0A4F4F9BD490A749D5437F821CF06DF1
Regulation for the Approval, Development, Oversight, and Control of Clinical Trials
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Indigenous
Searching for indicator indigenous:
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p.000019: SPECIAL EDITION
p.000019: Year I - No. 23
p.000019: Quito, Friday June 30, 2017
p.000019: Value: US $ 1.25 + VAT
p.000019: ABG JAQUELINE VARGAS CAMACHO DIRECTOR - SUBROGANTE
p.000019: Quito: Avenida 12 de Octubre N23-99 and Wilson Second Floor
p.000019: Headquarters and sales: Tel. 3941-800
p.000019: Exts .: 2301 - 230
p.000019: Distribution (Warehouse): Mañosca Nº 201 and Av. 10 de Agosto
p.000019: MINISTRY OF PUBLIC HEALTH
p.000019: MINISTERIAL AGREEMENT No. 0075-2017
p.000019: Tel. 243-0 10
p.000019: Guayaquil Branch:
p.000019: Av. 9 de Octubre Nº 1616 and Av. Del Army corner, Building of the Bar Association of Guayas, first floor. Tel.
p.000019: 252-7107
p.000019: Annual Subscription:
p.000019: US $ 400 + VAT for the city of Quito US $ 450 + VAT for the rest of the country
p.000019: Printed in National Editor 32 pages www.registroficial.gob.ec
p.000019: At the service of the country since July 1, 1895
p.000019: EXPAND THE REGULATIONS FOR THE APPROVAL, DEVELOPMENT, SURVEILLANCE AND CONTROL OF CLINICAL TRIALS
p.000019: 2 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: No. 0075-2017
p.000019: THE MINISTER OF PUBLIC HEALTH
p.000019: Considering:
p.000019: That, the Constitution of the Republic of Ecuador mandates: “Art. 57.- Communes are recognized and guaranteed,
p.000019: indigenous communities, peoples and nationalities, in accordance with the Constitution and with the pacts,
p.000019: conventions, declarations and other international human rights instruments, the following rights
p.000019: groups: (…)
p.000019: 12. Maintain, protect and develop collective knowledge; their sciences, technologies and knowledge
p.000019: ancestral; genetic resources that contain biological diversity and agro-bio-diversity;
p.000019: its medicines and traditional medicine practices, including the right to recover, promote
p.000019: and protect ritual and sacred places, as well as plants, animals, minerals and ecosystems within their
p.000019: territories; and knowledge of the resources and properties of fauna and flora. (…) ”;
p.000019: That, the Constitution of the Republic of Ecuador in subparagraph d), numeral 3, of article 66, prohibits
p.000019: the use of genetic material and scientific experimentation that threaten human rights;
p.000019: That, article 350 of the Constitution of the Republic of Ecuador states that the Higher Education System
p.000019: Its purpose is academic and professional training with a scientific and humanistic vision; the investigation
p.000019: scientific and technological; innovation, promotion, development and dissemination of knowledge and
p.000019: cultures; the construction of solutions for the country's problems, in relation to the objectives of the
p.000019: development;
p.000019: rectory functions in health; as well as the responsibility for the application, control and monitoring of compliance with
p.000019: this law; and, the norms that it dictates for its full validity will be obligatory. ”;
p.000019: That, the aforementioned Organic Health Law, in its article 6, orders:
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Political / criminal
Searching for indicator criminal:
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p.000019: - A delegate of the National Health Control Directorate;
p.000019: An Academy professional with experience in clinical research; Y,
p.000019: 16 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: An Academy professional with proven experience in the area of the proposed clinical study.
p.000019: The proposal of professional academic experts will be made by the members of the
p.000019: Committee belonging to the Ministry of Public Health, with seven (7) days in advance of the day of
p.000019: the meeting, by written communication addressed to the Vice Ministry of Governance and Surveillance of the
p.000019: Health. The profile of the proposed professional academic expert must be justified.
p.000019: The meetings of the Committee shall participate with voice and without vote: the General Certification Technical Coordinator
p.000019: of the National Agency for Regulation, Control and Health Surveillance - ARCSA, who will act as secretary;
p.000019: the technician who evaluated the clinical study at the ARCSA; and, a delegate of the Research Ethics Committee in Beings
p.000019: Humans who evaluated the study previously.
p.000019: Art. 94.- The Technical Advisory Committee on Clinical Research will meet with a minimum of four of
p.000019: The five members with voice and vote. The members of the Committee and those who participate with voice in these
p.000019: meetings, they will be obliged to keep absolute discretion and confidentiality about the file being evaluated.
p.000019: Once the Committee is formed, the members must sign a confidentiality document and not present
p.000019: interest conflict.
p.000019: established in the Organic Law of Health and other regulations in force on the subject, notwithstanding the
p.000019: civil or criminal penalties where applicable.
p.000019: CHAPTER XVII GLOSSARY OF TERMS
p.000019: Art. 98.- For the purposes of this Regulation, it is understood as:
p.000019: • Good manufacturing practices (GMP): set of rules and procedures to ensure that
p.000019: medicines, medical devices and food are constantly produced and controlled by standards
p.000019: of quality, from the entry of the materials until their release as a finished product.
p.000019: • Good clinical practice (BPC): standard for design, conduction, performance, monitoring, audit,
p.000019: registration, analysis and report of clinical studies that provides a guarantee that the data and
p.000019: the reported results are credible and accurate and that the rights, integrity and
p.000019: confidentiality of study subjects.
p.000019: • Good Laboratory Practices o: set of rules and procedures or erati os that guarantee that
p.000019: Art. 95.- The delegate of the Vice Ministry of Governance
p.000019: the data generated by e
p.000019: control laboratory
p.000019: and Health Surveillance, through the secretary, will summon the members of the Committee for its formation, each
p.000019: Once the ARCSA requests it, for the evaluation of a new clinical investigation, with at least ten (10) days term
p.000019: from
p.000019: Quality are complete quality.
p.000019: • Interest conflict
p.000019: reliable, reproducible and of
p.000019: yes ua ion in which the trial
p.000019: anticipation of the day of the meeting, which will be held at the ARCSA facilities. Attached to the call
p.000019: de ind viduo -c ncerniente to your primary interest-
p.000019: and the integri ad of an action tend to be
p.000019: The technical evaluation report of the study, prepared by the ARCSA, will be included.
p.000019: Art. 96.- The secretary shall prepare the Minutes of the meeting itself, which must contain the analysis of the report.
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Political / vulnerable
Searching for indicator vulnerable:
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p.000019: participation to the extent of its possibilities and
p.000019: OF THE SUBJECTS IN CLINICAL RESEARCH
p.000019: Art. 28.- The persons who investigate
p.000019: That the informed consent is legal representative.
p.000019: granted by his
p.000019: voluntarily participate in a clinical trial, who Art. 33.- In clinical studies
p.000019: made in villages
p.000019: must be previously informed about it,
p.000019: and nationality
p.000019: d l Ecuador, in addition to consent
p.000019: which must be recorded in an individual informed consent document, must be
p.000019: make an enquiry
p.000019: informed. These people may be healthy or suffer
p.000019: common taria
p.000019: prior, which should be favorable to the
p.000019: diseases. The research product will be supplied to the research subjects, or the product used
p.000019: as a control, once your informed consent or that of your legal representative has been obtained, in the
p.000019: If applicable.
p.000019: conduct of the study; and obtain additional approval from the community authorities involved in the case.
p.000019: This approval must be recorded in a document duly signed by these authorities, whose copy will be attached to
p.000019: the approval request procedures for the realization of
p.000019: clinical trial No clinical trials may be conducted in
p.000019: Art. 29.- Clinical trials carried out in older adults, people with disabilities, private persons d
p.000019: freedom and those who suffer from catastrophic diseases and high complexity, because they are considered groups
p.000019: of priority or vulnerable attention, should be of specific interest and limited to those whose
p.000019: nature can only be done in this population group.
p.000019: Art. 30.- In women of reproductive age who have agreed to participate in a clinical study, prior to
p.000019: At the beginning of the confirmation will be made that the participant is not pregnant.
p.000019: Access to and use of an effective contraceptive method during development should be ensured
p.000019: of the clinical trial, which will be provided at no cost by the study sponsor, during the entire time of your
p.000019: participation in it, including subjects in male research.
p.000019: Art. 31.- In case of pregnancy during the clinical trial, the woman will be
p.000019: excluded as subject in investigation; In addition, the study sponsor will monitor the
p.000019: patient and newborn until he has reached at least two (2) years of age. The sponsor
p.000019: must compensate
p.000019: people in voluntary isolation (not contacted).
p.000019: In these clinical studies, sponsors and researchers must develop forms and
p.000019: culturally appropriate means with anthropologists, sociologists and translators, to communicate to
p.000019: Participants in the investigation, all the necessary information regarding the trial and fulfill the
p.000019: standard required in the informed consent process. In addition, in the research protocol
p.000019: the procedure they plan to use to communicate the information to should be described and justified
p.000019: the subjects under investigation.
p.000019: CHAPTER IV
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Health / Drug Usage
Searching for indicator drug:
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p.000019: the one that states the obligations of each of the parties.
p.000019: d) The research protocol.
p.000019: e) The researcher's manual, as established in the Good Clinical Practices.
p.000019: f) The corresponding informed consent form to which the
p.000019: version of the research protocol presented, which has been previously approved by a Committee of
p.000019: Research Ethics in Human Beings.
p.000019: g) The pharmacological report on the marketing approval of the product under investigation
p.000019: issued by the ARCSA, if it were the case of post-marketing studies.
p.000019: h) The letters of declaration of institutional interest and
p.000019: to show experience in the specialty being studied; and, development training of
p.000019: clinical trials, Good Clinical Practices and related subjects.
p.000019: m) The schedule of the study to be carried out in the country.
p.000019: n) A certificate of the quality management system of the clinical laboratory or of the institution in the
p.000019: that is the clinical laboratory that will participate in the study.
p.000019: o) The detail of the product under investigation and other medicines to be used in the test,
p.000019: according to the model in Annex 2 of these Regulations, as well as the label of the product under investigation
p.000019: and packing.
p.000019: p) Health risk assessment reports in the previous phases of the studies (Phase I, II and III), for
p.000019: that the ARCSA establish the risk-benefit balance of the product under investigation.
p.000019: q) Certification of Good Manufacturing Practices of the drug manufacturing plant
p.000019: in research.
p.000019: r) The batch certification of the investigational drug, with stability and expiration date.
p.000019: s) The general budget of the trial, according to the model that
p.000019: availability of the health establishment for the
p.000019: It appears in Annex 3 of this
p.000019: Regulation.
p.000019: clinical trial, issued by the maximum
p.000019: authority of the establishments that are proposed
p.000019: t) Co ia del
p.000019: contract concluded between the researcher
p.000019: as clinical research centers.
p.000019: i) The commitment letter signed by the researcher
p.000019: Principals and the promoter.
p.000019: u) In cases where clinical research centers
p.000019: principal of
p.000019: each center
p.000019: clinical research
p.000019: are located in health facilities of
p.000019: participant in the clinical trial, in which it is indicated that he will participate as a researcher in the study, which has
p.000019: been trained on the research protocol and therefore knows it and is in compliance with it, the
p.000019: monetary value that you will receive for your services, as well as the determination of your responsibilities in the study.
p.000019: j) The list of the clinical research center or centers, which includes the details of all researchers and their
p.000019: work team by center, who would participate in the trial in the country, specifying the type of
p.000019: health establishment, professional titles of each member and their role in the study.
p.000019: k) Enrollment of the principal investigators of the study, in the database of the Ministry of
p.000019: Public Health by the National Directorate of Health Intelligence, or who exercises their powers, as long as
p.000019: the National Secretariat of Higher Education, Science, Technology and Research - SENESCYT develop this
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p.000019: following cases: if its effectiveness is demonstrated; and, when its suspension jeopardizes the safety of the
p.000019: subject under investigation and there is no therapeutic option that can replace the study treatment
p.000019: in the market and until the product is marketed in the country.
p.000019: Art. 40.- In cases where the use of placebo is authorized in a clinical study, prior to obtaining the
p.000019: informed consent of the participants, they will be informed with sufficient time and clearly in what
p.000019: This process consists.
p.000019: The use of placebo should be considered in cases where there is no therapy, intervention,
p.000019: medication or procedure of proven efficacy for the problem investigated; and in others it must be analyzed
p.000019: on a case-by-case basis by the CEISH and by the ARCSA, in order to minimize risks and not affect the safety of
p.000019: subjects under investigation, ensuring that they do not run additional risks, serious adverse effects or damages
p.000019: irreversible as a result of not receiving the best proven intervention.
p.000019: Art. 45.- In the event that the product under investigation is manufactured in the country, the ARCSA will carry out inspections.
p.000019: to verify the manufacturing process.
p.000019: Art. 46.- The laboratory manufacturing the product under investigation must comply with the Standards of
p.000019: Good Manufacturing Practices established by national regulations for the elaboration of a product
p.000019: pharmacological, presenting the different quality and stability certifications in the product file
p.000019: of the drug.
p.000019: The product under investigation must be properly labeled on the primary container with ink
p.000019: indelible in Spanish language, indicating at least the data that identify the sponsor, to the clinical trial
p.000019: and to the product under investigation and its expiration date, protocol code, product code,
p.000019: lot number, number of units and dosage form, route of administration, storage conditions,
p.000019: conservation and use thereof. Additionally, the labeling must specify the phrases “Prohibited its
p.000019: sale ”and“ product for exclusive research use ”. In the case of primary packaging
p.000019: 10 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: that because of its space they do not allow to establish this information, it will be printed in a secondary container.
p.000019: Art. 47.- In the review of the clinical trial, the ARCSA will analyze how the management of the
p.000019: product under investigation, according to the Standards of Good Manufacturing Practices and studying, between
p.000019: Other points, control of records, packaging, labeling and coding, procedure for
p.000019: dispensing, storage and location thereof.
p.000019: Art. 48.- Surplus and / or expired research products at the conclusion or suspension of the trial
p.000019: clinical, should be destroyed by the sponsor or his delegate, according to the procedure established in the
p.000019: corresponding regulations.
p.000019: Leftover reagents not used in the investigation that are in good condition may be
p.000019: donated, in accordance with current regulations.
p.000019: Art. 49.- It may be exempted from the destruction referred to in the previous article to the products in
p.000019: investigation, prior authorization of the ARCSA, in the following cases:
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p.000019: del es udio, d
p.000019: compliance with regulations
p.000019: be your employment, according to the conditions of us in the sanitary registry.
p.000019: CHAPTER VI
p.000019: approves
p.000019: that for the effect or issue the ARCSA.
p.000019: CHAPTER VII
p.000019: ON THE USE OF MEDICINES IN
p.000019: OF THE NOTIFICATION OF E
p.000019: ADVERSE BETWEEN
p.000019: CLINICAL RESEARCH
p.000019: AND REACTIONS ADVE SAS
p.000019: Art. 50.- The principal investigator must notify the ARCSA, the sponsor or the Organization of
p.000019: Contract Research and the corresponding Research Ethics Committee in Human Beings, all
p.000019: serious adverse events and all suspicions of unexpected serious adverse reactions that occur during
p.000019: the clinical study, in a period not exceeding twenty-four (24) hours after the event was known, as well
p.000019: such as abnormal laboratory results that the protocol considers determinants and that may influence the
p.000019: safety assessment, within the periods specified in said protocol. It is also the obligation of
p.000019: Principal investigator send to the sponsor or the Contract Research Organization, to the ARCSA and
p.000019: to the corresponding Research Ethics Committee in Human Beings, a follow-up report and
p.000019: Causality assessment on suspicions of unexpected serious adverse reactions occurred.
p.000019: Art. 51.- In the case of a relevant safety problem in the development of the clinical trial, the
p.000019: Principal investigator is obliged to immediately notify the acquaintance, the ARCSA and the sponsor.
p.000019: Art. 56.- For the ARCSA to authorize the use of an investigational drug, which could be understood as
p.000019: extended use of this medicine, to treat patients in conditions in which their lives are in danger,
p.000019: will consider the following:
p.000019: a) Clinical report in which the attending physician justifies the use of the medicine, determining
p.000019: that there is no therapeutic alternative available for the patient's disease and that the risk for
p.000019: person is not older than the one faced by the disease he suffers.
p.000019: b) The informed consent of the patient or his legal representative, when applicable.
p.000019: c) That the producer of the medicine agrees with the free endowment of the drug, after the evaluation
p.000019: Case clinic and consultation of the attending physician
p.000019: Art. 57.- The doctor responsible for applying the medication under the conditions of this Chapter shall notify the
p.000019: ARCSA the results of it.
p.000019: Official Registry - Special Edition Nº 23
p.000019: Art. 58.- The use in exceptional conditions of a drug under investigation, to treat
p.000019: patients in conditions in which their lives are in danger, it is a process that does not correspond to a clinical trial of
p.000019: investigational medications, and will be performed when a doctor, under your responsibility,
p.000019: justify with a clinical report the use of the medicine because it considers its
p.000019: use. The ARCSA must authorize the use of any investigational medication under exceptional conditions.
p.000019: CHAPTER VIII
p.000019: OF THE REGISTRATION AND PUBLICATION BASE OF CLINICAL TRIALS
p.000019: Art. 59.- The ARCSA will create and maintain the National Registry of Clinical Trials, observing the requirements of the
p.000019: Primary Registry of the World Health Organization. This record will be a publicly accessible database. The
p.000019: Agency will provide access to this registry and additional information that the Ministry of Public Health requires
p.000019: for the purpose of monitoring and control of the investigation.
p.000019: Art. 60.- In the case of publication of results of a clinical trial developed in Ecuador in
p.000019: national or international scientific journals, the researcher will send a mandatory
p.000019: copy of said publication to the ARCSA and the Ministry of Public Health. Such publications in any case
p.000019: will contain identification data of the study subjects.
p.000019: Friday, June 30, 2017 - 11
p.000019: Art. 63.- CEISH members must prove knowledge and experience in relation to ethical aspects,
p.000019: methodological and legal clinical research, good clinical practices and clinical practice
p.000019: welfare. They must excuse their participation in the evaluation of research projects in which they could have
p.000019: interest conflict.
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p.000019: exact copies, microfiche, photographic negatives, magnetic media or microfilm, x-rays, records of
p.000019: subjects and records kept in the pharmacy, in laboratories and in medical-technical departments
p.000019: involved in the clinical study.
p.000019: • Amendment: written description of the change or changes to the research protocol to the researcher's manual
p.000019: and / or informed consent, which does not modify the objectives, the time of treatment and the product in
p.000019: investigation.
p.000019: Official Registry - Special Edition Nº 23
p.000019: • Clinical Trial: is any investigation that is carried out in humans with the intention of
p.000019: discover or verify the clinical, pharmacological and / or any other pharmacodynamic effects of
p.000019: product (s) under investigation and / or identify any adverse reaction to research product (s)
p.000019: and / or to study the absorption, distribution, metabolism and excretion of product (s) under investigation, with
p.000019: The purpose of checking its safety and / or effectiveness. In these Regulations the terms are used interchangeably
p.000019: "Essay" and "study", without there being, for the purpose of this instrument, any difference in its meaning and scope.
p.000019: • Adverse event (EA): any adverse health incident that occurs in a
p.000019: subject or participant in clinical research, to whom a research product has been administered,
p.000019: although it does not necessarily have a causal relationship with the product under study. An adverse event can be, by
p.000019: therefore, any unfavorable and unintended sign (including an abnormal laboratory finding),
p.000019: symptom or illness temporarily associated with the use of a drug or product under investigation, whether or not
p.000019: related to it.
p.000019: • Serious Adverse Event: any event that occurs in the context of a clinical trial, without
p.000019: it is necessarily related to causality with the product under investigation, and that produces: the death of the subject in
p.000019: investigation, put the subject's life at risk, make the subject's hospitalization necessary or prolong his
p.000019: stay, produce permanent or significant disability or disability, or place a
p.000019: Friday, June 30, 2017 - 17
p.000019: commercialization; provide additional information on efficacy, effectiveness and long-term safety (risk-
p.000019: benefit). They are performed under conditions of usual medical practice and in large numbers of subjects during a
p.000019: prolonged period Also known as post-marketing, post-registration or
p.000019: Pharmacovigilance
p.000019: • Inspection: for the purposes of this regulation, the verification or revision action is understood as such
p.000019: developed by the National Health Authority through the National Agency for Regulation, Control and
p.000019: Health Surveillance (ARCSA), to documents, facilities, files, quality assurance systems and
p.000019: Any other resource that ARCSA considers is related to a clinical study.
p.000019: • Nonprofit clinical research: research conducted by researchers without the
p.000019: Participation of the pharmaceutical or pharmaceutical industry that meets the following requirements: 1)
p.000019: Sponsor is the academy, a public hospital, a public research institute or entities
p.000019: public; 2) the ownership of the research data belongs to the sponsor from the first moment of the
p.000019: study;
p.000019: 3) there are no agreements between the sponsor and third parties that allow the use of the data for uses that
p.000019: generate an in ustrial property; 4) design, implementation, recruitment, data collection and
p.000019: the dissemination of research results is kept under the control of the sponsor; and, 4) for their
p.000019: characteristic, these studies cannot be part
p.000019: from a development program for an authorization of
p.000019: congenital anomaly or malformation.
p.000019: • Phase I: research in humans where a substance, new drug, is first used
p.000019: or new formulation to provide preliminary information on product safety and establish the
p.000019: tolerability and feasibility thereof. They are usually performed in healthy volunteers or in
p.000019: Some specific cases in patients. They comprise trials of pharmacokinetics and pharmacodynamics.
p.000019: They guide the most appropriate administration schedule for more advanced clinical trials.
p.000019: • Phase II: research in humans where dose / response relationships and the
p.000019: pharmacological effect of new drugs and new therapeutic regimens are identified.
p.000019: Its main objective is to provide preliminary information on the effectiveness of the product and expand the
p.000019: safety data obtained in previous studies. They are performed on patients affected by a certain
p.000019: disease or pathological condition under strict monitoring.
p.000019: • Phase III: research in human beings aimed at assessing the efficacy and safety of
p.000019: experimental treatment, trying to reproduce the usual conditions of use and considering the
p.000019: therapeutic alternatives available in the indication studied. They are controlled and randomized and ideally to
p.000019: triple blind They constitute the gold standard to evaluate new therapeutic alternatives.
p.000019: • Phase IV: investigations in human beings that are carried out once the product in
p.000019: investigation has obtained the sanitary record authorizing its
p.000019: Productization of a product.
p.000019: • Stigner's manual: it is a compilation of the clinical and non-clinical data of the
p.000019: product under investigation, which are relevant for the study of it in humans. Your goal is
p.000019: provide researchers and other people involved in the study with the information to
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Searching for indicator influence:
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p.000019: If a conflict of opinion arises between the subject under investigation and his legal representative, regarding his
p.000019: Participation in the clinical trial, at any time during or before the study, will exclude
p.000019: subject provided that such exclusion does not jeopardize your health.
p.000019: In any case of exclusion of a participant from a clinical trial, the investigator and the
p.000019: Sponsor will guarantee the monitoring of the subject for at least two (2) years.
p.000019: Art. 35.- The principal investigator or a delegate thereof who is part of the research team,
p.000019: inform in writing and verbally the subject under investigation or his legal representative, when
p.000019: appropriate, regarding the risks, discomforts and possible benefits of the study in which it is raised
p.000019: your participation, using simple, clear and warm terms.
p.000019: Art. 36.- In the case of illiterate persons, their fingerprint will be registered in the document of
p.000019: consent
p.000019: d) Selection criteria, exclusion and number of subjects under investigation.
p.000019: e) Duration, side effects, direct benefits of participation in the clinical trial, the expected risks
p.000019: for the subject, including possible adverse reactions, risks to the health and well-being of the couple or
p.000019: spouse. Possible benefits for the community or society.
p.000019: f) Alternative treatments that could be beneficial for the subject under investigation.
p.000019: g) Point out that the participation of the subject in the clinical trial is voluntary and that their decision to participate
p.000019: or not the study will not influence in any way the health care process that the subject requires in
p.000019: investigation.
p.000019: h) Information about the product or products under investigation.
p.000019: i) Causes that could cause the suspension of the subject's participation in the study.
p.000019: j) Point out the potential risks in case of pregnancy and the importance of using
p.000019: an effective contraceptive method, if the subjects that are part of the study are of age
p.000019: reproductive
p.000019: k) The responsibilities of the research team.
p.000019: informed and will sign as witnesses two people who e
p.000019: l) L li ertad que the subject in investigation of
p.000019: study participant choose, as long as they have no conflict of interest with the research that was developed
p.000019: It will be linked and not linked in any way with the research team.
p.000019: Art. 37.- The consent document informs or any other informative material, that in relation
p.000019: to the study be provided to the subjects under investigation must be previously reviewed and approved by a
p.000019: Committee of Research Ethics in Human Beings, recognized by the Ministry of Public Health.
p.000019: Art. 38.- The informed consent document may not contain any expression that gives rise to
p.000019: that the subject who consents to it, exempts the sponsor, researcher or his or her responsibility
p.000019: representatives before any responsibility for negligence, or for risks derived from the clinical trial.
p.000019: Art. 39.- The informed consent document for clinical research must contain the following (Annex 4):
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p.000019: used.
p.000019: Art. 55.- The ARCSA will maintain a pharmacovigilance system to monitor the
p.000019: reports of serious adverse events and about unexpected serious adverse reactions. A clinical assistant can
p.000019: be suspended by the ARCSA justifiably, after the analysis of the
p.000019: b) When delivered in donation, by means of an agreement
p.000019: number, graveda
p.000019: and frequency
p.000019: of adverse events, the
p.000019: between the sponsor and the beneficiary institution of the
p.000019: type of study and population of
p.000019: test, and inspection
p.000019: donation, only e
p.000019: the cases in which the product
p.000019: corresponding, in order to precautionary the security of
p.000019: have a sanitary record and the purpose of the gift
p.000019: the subject
p.000019: del es udio, d
p.000019: compliance with regulations
p.000019: be your employment, according to the conditions of us in the sanitary registry.
p.000019: CHAPTER VI
p.000019: approves
p.000019: that for the effect or issue the ARCSA.
p.000019: CHAPTER VII
p.000019: ON THE USE OF MEDICINES IN
p.000019: OF THE NOTIFICATION OF E
p.000019: ADVERSE BETWEEN
p.000019: CLINICAL RESEARCH
p.000019: AND REACTIONS ADVE SAS
p.000019: Art. 50.- The principal investigator must notify the ARCSA, the sponsor or the Organization of
p.000019: Contract Research and the corresponding Research Ethics Committee in Human Beings, all
p.000019: serious adverse events and all suspicions of unexpected serious adverse reactions that occur during
p.000019: the clinical study, in a period not exceeding twenty-four (24) hours after the event was known, as well
p.000019: such as abnormal laboratory results that the protocol considers determinants and that may influence the
p.000019: safety assessment, within the periods specified in said protocol. It is also the obligation of
p.000019: Principal investigator send to the sponsor or the Contract Research Organization, to the ARCSA and
p.000019: to the corresponding Research Ethics Committee in Human Beings, a follow-up report and
p.000019: Causality assessment on suspicions of unexpected serious adverse reactions occurred.
p.000019: Art. 51.- In the case of a relevant safety problem in the development of the clinical trial, the
p.000019: Principal investigator is obliged to immediately notify the acquaintance, the ARCSA and the sponsor.
p.000019: Art. 56.- For the ARCSA to authorize the use of an investigational drug, which could be understood as
p.000019: extended use of this medicine, to treat patients in conditions in which their lives are in danger,
p.000019: will consider the following:
p.000019: a) Clinical report in which the attending physician justifies the use of the medicine, determining
p.000019: that there is no therapeutic alternative available for the patient's disease and that the risk for
p.000019: person is not older than the one faced by the disease he suffers.
p.000019: b) The informed consent of the patient or his legal representative, when applicable.
p.000019: c) That the producer of the medicine agrees with the free endowment of the drug, after the evaluation
p.000019: Case clinic and consultation of the attending physician
...
p.000019: Identify as “Prohibited its sale” and “product for exclusive use in research”.
p.000019: p) Keep a main file of the clinical trial with all the documentation related to its realization.
p.000019: This file will be kept and will be available to the ARCSA and the Ministry of Public Health when
p.000019: request, during the following seven (7) years after the end of the investigation in the country.
p.000019: Art. 75.- Once the investigation is finished, in the cases in which the effectiveness and
p.000019: medication safety, after analysis of study data, the sponsor will be responsible for
p.000019: Provide the research product free of charge to the research subjects, when the
p.000019: interruption of life-threatening treatment or seriously affect the patient's condition, or there is no
p.000019: another therapeutic option marketed in the country that can replace the product under study.
p.000019: Art. 76.- The sponsor of the clinical trial will not offer any incentive or economic stimulus to the
p.000019: subject under investigation who suffers from any disease, or his legal representative. When applicable,
p.000019: will compensate the subject under investigation with the expenses inherent in transportation, accommodation, food and loss
p.000019: of productivity derived from their participation in the study. These expenses must be
p.000019: considered in the budget of the
p.000019: Official Registry - Special Edition Nº 23
p.000019: investigation and explicitly indicated in the informed consent document. The remuneration must have a
p.000019: reasonable amount, at the discretion of the Research Ethics Committee on Human Beings and the ARCSA, so that
p.000019: does not influence the informed consent of the subject under investigation.
p.000019: Art. 77.- Healthy volunteers participating in studies may receive incentives from the sponsor
p.000019: clinical. These incentives must be detailed in the informed consent document. A
p.000019: Healthy volunteer may not be recruited, or participate repeatedly in the development of clinical trials.
p.000019: CHAPTER XI
p.000019: OF CONTRACT RESEARCH ORGANIZATIONS
p.000019: Art. 78.- A Contract Research Organization is a public or private company,
p.000019: national or foreign, legally domiciled in the country, to which the sponsor officially transfers
p.000019: in writing some or all of its functions and / or obligations related to a research study
p.000019: by contract signed by both parties; however, the final responsibility for the execution of the protocol
p.000019: of research, of the results and of the clinical trial, in its entirety, is of the sponsor.
p.000019: Art. 79.- Contract Research Organizations
p.000019: Friday, June 30, 2017 - 13
p.000019: Art. 82.- Contract Research Organizations must implement a process of assurance and control of
p.000019: quality, documented in standard operating procedures. These procedures must be in writing,
p.000019: before the start of a clinical trial.
p.000019: Art. 83.- The sponsor of the clinical trial must specify through a contract or agreement
p.000019: legalized, the activity and function related to the study that are delegated to an Organization of
p.000019: Contract Research. Investigation procedures that are not specifically transferred to
p.000019: The Contract Research Organization must be performed by the sponsor.
...
Searching for indicator substance:
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p.000019: commercialization; provide additional information on efficacy, effectiveness and long-term safety (risk-
p.000019: benefit). They are performed under conditions of usual medical practice and in large numbers of subjects during a
p.000019: prolonged period Also known as post-marketing, post-registration or
p.000019: Pharmacovigilance
p.000019: • Inspection: for the purposes of this regulation, the verification or revision action is understood as such
p.000019: developed by the National Health Authority through the National Agency for Regulation, Control and
p.000019: Health Surveillance (ARCSA), to documents, facilities, files, quality assurance systems and
p.000019: Any other resource that ARCSA considers is related to a clinical study.
p.000019: • Nonprofit clinical research: research conducted by researchers without the
p.000019: Participation of the pharmaceutical or pharmaceutical industry that meets the following requirements: 1)
p.000019: Sponsor is the academy, a public hospital, a public research institute or entities
p.000019: public; 2) the ownership of the research data belongs to the sponsor from the first moment of the
p.000019: study;
p.000019: 3) there are no agreements between the sponsor and third parties that allow the use of the data for uses that
p.000019: generate an in ustrial property; 4) design, implementation, recruitment, data collection and
p.000019: the dissemination of research results is kept under the control of the sponsor; and, 4) for their
p.000019: characteristic, these studies cannot be part
p.000019: from a development program for an authorization of
p.000019: congenital anomaly or malformation.
p.000019: • Phase I: research in humans where a substance, new drug, is first used
p.000019: or new formulation to provide preliminary information on product safety and establish the
p.000019: tolerability and feasibility thereof. They are usually performed in healthy volunteers or in
p.000019: Some specific cases in patients. They comprise trials of pharmacokinetics and pharmacodynamics.
p.000019: They guide the most appropriate administration schedule for more advanced clinical trials.
p.000019: • Phase II: research in humans where dose / response relationships and the
p.000019: pharmacological effect of new drugs and new therapeutic regimens are identified.
p.000019: Its main objective is to provide preliminary information on the effectiveness of the product and expand the
p.000019: safety data obtained in previous studies. They are performed on patients affected by a certain
p.000019: disease or pathological condition under strict monitoring.
p.000019: • Phase III: research in human beings aimed at assessing the efficacy and safety of
p.000019: experimental treatment, trying to reproduce the usual conditions of use and considering the
p.000019: therapeutic alternatives available in the indication studied. They are controlled and randomized and ideally to
p.000019: triple blind They constitute the gold standard to evaluate new therapeutic alternatives.
p.000019: • Phase IV: investigations in human beings that are carried out once the product in
p.000019: investigation has obtained the sanitary record authorizing its
p.000019: Productization of a product.
p.000019: • Stigner's manual: it is a compilation of the clinical and non-clinical data of the
p.000019: product under investigation, which are relevant for the study of it in humans. Your goal is
p.000019: provide researchers and other people involved in the study with the information to
p.000019: facilitate the understanding of the foundation and the fulfillment of several important characteristics of the
p.000019: protocol, such as dose, frequency / dose range, administration methods and monitoring procedures for
p.000019: security.
p.000019: • Monitor: Qualified person to follow up the process of a clinical study and ensure that it
p.000019: be conducted, recorded and reported in accordance with the protocol, standard operating procedures, Good
p.000019: Clinical Practices and applicable regulatory requirements.
p.000019: • Placebo: Product with pharmaceutical form, which contains a pharmacologically inert substance that
p.000019: acts as a comparator in a clinical study, without it having specific pharmacological activity for
p.000019: condition studied.
p.000019: • Standard Operating Procedures (SOPs): Detailed and written instructions for
p.000019: achieve uniformity in the execution of a specific function.
p.000019: • Serious adverse reaction: Any adverse reaction that at any dose causes death threatens the
p.000019: life of the subject under investigation, produces permanent or substantial disability, requires hospitalization
p.000019: 18 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: or prolongs hospitalization time, causes anomaly or congenital malformation.
p.000019: • Serious and unexpected adverse reaction: Reaction whose nature, severity or outcome are not consistent
p.000019: with the reference safety information of the product under investigation.
p.000019: GENERAL DISPOSITION
p.000019: FIRST.- The National Agency for Regulation, Control and Health Surveillance - ARCSA will verify in
p.000019: the entire national territory, compliance with the suspension or cancellation of trials
p.000019: clinicians that run in the country and if necessary will request support from their Zonal Coordinations.
p.000019: SECOND.- If necessary, within the approval, control and surveillance processes of a clinical trial, the
p.000019: ARCSA will request additional information from the sponsor described in this instrument.
p.000019: THIRD.- In the case of import and / or export of biological samples for the purpose of
p.000019: investigation, the sponsor must request the corresponding authorization from the ARCSA, which will issue it
p.000019: verifying compliance with the constitutional provisions regarding the protection of
...
Health / Healthy People
Searching for indicator healthy volunteers:
(return to top)
p.000019: This file will be kept and will be available to the ARCSA and the Ministry of Public Health when
p.000019: request, during the following seven (7) years after the end of the investigation in the country.
p.000019: Art. 75.- Once the investigation is finished, in the cases in which the effectiveness and
p.000019: medication safety, after analysis of study data, the sponsor will be responsible for
p.000019: Provide the research product free of charge to the research subjects, when the
p.000019: interruption of life-threatening treatment or seriously affect the patient's condition, or there is no
p.000019: another therapeutic option marketed in the country that can replace the product under study.
p.000019: Art. 76.- The sponsor of the clinical trial will not offer any incentive or economic stimulus to the
p.000019: subject under investigation who suffers from any disease, or his legal representative. When applicable,
p.000019: will compensate the subject under investigation with the expenses inherent in transportation, accommodation, food and loss
p.000019: of productivity derived from their participation in the study. These expenses must be
p.000019: considered in the budget of the
p.000019: Official Registry - Special Edition Nº 23
p.000019: investigation and explicitly indicated in the informed consent document. The remuneration must have a
p.000019: reasonable amount, at the discretion of the Research Ethics Committee on Human Beings and the ARCSA, so that
p.000019: does not influence the informed consent of the subject under investigation.
p.000019: Art. 77.- Healthy volunteers participating in studies may receive incentives from the sponsor
p.000019: clinical. These incentives must be detailed in the informed consent document. A
p.000019: Healthy volunteer may not be recruited, or participate repeatedly in the development of clinical trials.
p.000019: CHAPTER XI
p.000019: OF CONTRACT RESEARCH ORGANIZATIONS
p.000019: Art. 78.- A Contract Research Organization is a public or private company,
p.000019: national or foreign, legally domiciled in the country, to which the sponsor officially transfers
p.000019: in writing some or all of its functions and / or obligations related to a research study
p.000019: by contract signed by both parties; however, the final responsibility for the execution of the protocol
p.000019: of research, of the results and of the clinical trial, in its entirety, is of the sponsor.
p.000019: Art. 79.- Contract Research Organizations
p.000019: Friday, June 30, 2017 - 13
p.000019: Art. 82.- Contract Research Organizations must implement a process of assurance and control of
p.000019: quality, documented in standard operating procedures. These procedures must be in writing,
p.000019: before the start of a clinical trial.
p.000019: Art. 83.- The sponsor of the clinical trial must specify through a contract or agreement
p.000019: legalized, the activity and function related to the study that are delegated to an Organization of
p.000019: Contract Research. Investigation procedures that are not specifically transferred to
p.000019: The Contract Research Organization must be performed by the sponsor.
p.000019: Art. 84.- Among the functions of the Research Organizations by Contract for the
p.000019: The development of a clinical trial, other than those delegated by the sponsor, may be carried out
p.000019: following:
...
p.000019: Pharmacovigilance
p.000019: • Inspection: for the purposes of this regulation, the verification or revision action is understood as such
p.000019: developed by the National Health Authority through the National Agency for Regulation, Control and
p.000019: Health Surveillance (ARCSA), to documents, facilities, files, quality assurance systems and
p.000019: Any other resource that ARCSA considers is related to a clinical study.
p.000019: • Nonprofit clinical research: research conducted by researchers without the
p.000019: Participation of the pharmaceutical or pharmaceutical industry that meets the following requirements: 1)
p.000019: Sponsor is the academy, a public hospital, a public research institute or entities
p.000019: public; 2) the ownership of the research data belongs to the sponsor from the first moment of the
p.000019: study;
p.000019: 3) there are no agreements between the sponsor and third parties that allow the use of the data for uses that
p.000019: generate an in ustrial property; 4) design, implementation, recruitment, data collection and
p.000019: the dissemination of research results is kept under the control of the sponsor; and, 4) for their
p.000019: characteristic, these studies cannot be part
p.000019: from a development program for an authorization of
p.000019: congenital anomaly or malformation.
p.000019: • Phase I: research in humans where a substance, new drug, is first used
p.000019: or new formulation to provide preliminary information on product safety and establish the
p.000019: tolerability and feasibility thereof. They are usually performed in healthy volunteers or in
p.000019: Some specific cases in patients. They comprise trials of pharmacokinetics and pharmacodynamics.
p.000019: They guide the most appropriate administration schedule for more advanced clinical trials.
p.000019: • Phase II: research in humans where dose / response relationships and the
p.000019: pharmacological effect of new drugs and new therapeutic regimens are identified.
p.000019: Its main objective is to provide preliminary information on the effectiveness of the product and expand the
p.000019: safety data obtained in previous studies. They are performed on patients affected by a certain
p.000019: disease or pathological condition under strict monitoring.
p.000019: • Phase III: research in human beings aimed at assessing the efficacy and safety of
p.000019: experimental treatment, trying to reproduce the usual conditions of use and considering the
p.000019: therapeutic alternatives available in the indication studied. They are controlled and randomized and ideally to
p.000019: triple blind They constitute the gold standard to evaluate new therapeutic alternatives.
p.000019: • Phase IV: investigations in human beings that are carried out once the product in
p.000019: investigation has obtained the sanitary record authorizing its
p.000019: Productization of a product.
p.000019: • Stigner's manual: it is a compilation of the clinical and non-clinical data of the
p.000019: product under investigation, which are relevant for the study of it in humans. Your goal is
p.000019: provide researchers and other people involved in the study with the information to
p.000019: facilitate the understanding of the foundation and the fulfillment of several important characteristics of the
p.000019: protocol, such as dose, frequency / dose range, administration methods and monitoring procedures for
p.000019: security.
...
Health / Mentally Disabled
Searching for indicator disability:
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p.000019: Started the execution of the clinical trial.
p.000019: j) Adulterate or falsify the information required in this Regulation or related data
p.000019: With the essay.
p.000019: k) Not guarantee the protection, benefits, rights and security of the subjects participating in the
p.000019: clinical research.
p.000019: l) Failure to comply with the provisions established in this Regulation.
p.000019: Art. 27.- In the event that the ARCSA detects and verifies the conduct and conduct of a clinical trial without
p.000019: the corresponding approval will provide both the cancellation of the study and the execution of measures that protect
p.000019: the subjects under investigation, in addition to applying the sanctions to which it may take place.
p.000019: CHAPTER III
p.000019: Friday, June 30, 2017 - 7
p.000019: both the mother and the newborn of presenting subsequent damages produced during pregnancy or
p.000019: would have caused the newborn due to the execution of the investigation.
p.000019: Art. 32.- Persons with disabilities may be subject to investigation, provided that the Committee on
p.000019: Research Ethics in Human Beings that evaluate the clinical trial, establish compliance with the
p.000019: following conditions:
p.000019: a) That the research responds to the health needs and priorities of the population with disabilities and
p.000019: cannot be done in other groups;
p.000019: b) That the research is designed to minimize the risks of the condition you suffer and that the benefits are
p.000019: exceeding the risks inherent in the study; Y,
p.000019: c) That in cases of mental disability, in the process of obtaining informed consent,
p.000019: people have received information from the clinical study adapted to their ability to understand, guaranteeing their
p.000019: participation to the extent of its possibilities and
p.000019: OF THE SUBJECTS IN CLINICAL RESEARCH
p.000019: Art. 28.- The persons who investigate
p.000019: That the informed consent is legal representative.
p.000019: granted by his
p.000019: voluntarily participate in a clinical trial, who Art. 33.- In clinical studies
p.000019: made in villages
p.000019: must be previously informed about it,
p.000019: and nationality
p.000019: d l Ecuador, in addition to consent
p.000019: which must be recorded in an individual informed consent document, must be
p.000019: make an enquiry
p.000019: informed. These people may be healthy or suffer
p.000019: common taria
p.000019: prior, which should be favorable to the
p.000019: diseases. The research product will be supplied to the research subjects, or the product used
p.000019: as a control, once your informed consent or that of your legal representative has been obtained, in the
p.000019: If applicable.
p.000019: conduct of the study; and obtain additional approval from the community authorities involved in the case.
p.000019: This approval must be recorded in a document duly signed by these authorities, whose copy will be attached to
p.000019: the approval request procedures for the realization of
p.000019: clinical trial No clinical trials may be conducted in
p.000019: Art. 29.- Clinical trials carried out in older adults, people with disabilities, private persons d
...
p.000019: Official Registry - Special Edition Nº 23
p.000019: • Clinical Trial: is any investigation that is carried out in humans with the intention of
p.000019: discover or verify the clinical, pharmacological and / or any other pharmacodynamic effects of
p.000019: product (s) under investigation and / or identify any adverse reaction to research product (s)
p.000019: and / or to study the absorption, distribution, metabolism and excretion of product (s) under investigation, with
p.000019: The purpose of checking its safety and / or effectiveness. In these Regulations the terms are used interchangeably
p.000019: "Essay" and "study", without there being, for the purpose of this instrument, any difference in its meaning and scope.
p.000019: • Adverse event (EA): any adverse health incident that occurs in a
p.000019: subject or participant in clinical research, to whom a research product has been administered,
p.000019: although it does not necessarily have a causal relationship with the product under study. An adverse event can be, by
p.000019: therefore, any unfavorable and unintended sign (including an abnormal laboratory finding),
p.000019: symptom or illness temporarily associated with the use of a drug or product under investigation, whether or not
p.000019: related to it.
p.000019: • Serious Adverse Event: any event that occurs in the context of a clinical trial, without
p.000019: it is necessarily related to causality with the product under investigation, and that produces: the death of the subject in
p.000019: investigation, put the subject's life at risk, make the subject's hospitalization necessary or prolong his
p.000019: stay, produce permanent or significant disability or disability, or place a
p.000019: Friday, June 30, 2017 - 17
p.000019: commercialization; provide additional information on efficacy, effectiveness and long-term safety (risk-
p.000019: benefit). They are performed under conditions of usual medical practice and in large numbers of subjects during a
p.000019: prolonged period Also known as post-marketing, post-registration or
p.000019: Pharmacovigilance
p.000019: • Inspection: for the purposes of this regulation, the verification or revision action is understood as such
p.000019: developed by the National Health Authority through the National Agency for Regulation, Control and
p.000019: Health Surveillance (ARCSA), to documents, facilities, files, quality assurance systems and
p.000019: Any other resource that ARCSA considers is related to a clinical study.
p.000019: • Nonprofit clinical research: research conducted by researchers without the
p.000019: Participation of the pharmaceutical or pharmaceutical industry that meets the following requirements: 1)
p.000019: Sponsor is the academy, a public hospital, a public research institute or entities
p.000019: public; 2) the ownership of the research data belongs to the sponsor from the first moment of the
p.000019: study;
p.000019: 3) there are no agreements between the sponsor and third parties that allow the use of the data for uses that
p.000019: generate an in ustrial property; 4) design, implementation, recruitment, data collection and
p.000019: the dissemination of research results is kept under the control of the sponsor; and, 4) for their
p.000019: characteristic, these studies cannot be part
p.000019: from a development program for an authorization of
p.000019: congenital anomaly or malformation.
...
p.000019: triple blind They constitute the gold standard to evaluate new therapeutic alternatives.
p.000019: • Phase IV: investigations in human beings that are carried out once the product in
p.000019: investigation has obtained the sanitary record authorizing its
p.000019: Productization of a product.
p.000019: • Stigner's manual: it is a compilation of the clinical and non-clinical data of the
p.000019: product under investigation, which are relevant for the study of it in humans. Your goal is
p.000019: provide researchers and other people involved in the study with the information to
p.000019: facilitate the understanding of the foundation and the fulfillment of several important characteristics of the
p.000019: protocol, such as dose, frequency / dose range, administration methods and monitoring procedures for
p.000019: security.
p.000019: • Monitor: Qualified person to follow up the process of a clinical study and ensure that it
p.000019: be conducted, recorded and reported in accordance with the protocol, standard operating procedures, Good
p.000019: Clinical Practices and applicable regulatory requirements.
p.000019: • Placebo: Product with pharmaceutical form, which contains a pharmacologically inert substance that
p.000019: acts as a comparator in a clinical study, without it having specific pharmacological activity for
p.000019: condition studied.
p.000019: • Standard Operating Procedures (SOPs): Detailed and written instructions for
p.000019: achieve uniformity in the execution of a specific function.
p.000019: • Serious adverse reaction: Any adverse reaction that at any dose causes death threatens the
p.000019: life of the subject under investigation, produces permanent or substantial disability, requires hospitalization
p.000019: 18 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: or prolongs hospitalization time, causes anomaly or congenital malformation.
p.000019: • Serious and unexpected adverse reaction: Reaction whose nature, severity or outcome are not consistent
p.000019: with the reference safety information of the product under investigation.
p.000019: GENERAL DISPOSITION
p.000019: FIRST.- The National Agency for Regulation, Control and Health Surveillance - ARCSA will verify in
p.000019: the entire national territory, compliance with the suspension or cancellation of trials
p.000019: clinicians that run in the country and if necessary will request support from their Zonal Coordinations.
p.000019: SECOND.- If necessary, within the approval, control and surveillance processes of a clinical trial, the
p.000019: ARCSA will request additional information from the sponsor described in this instrument.
p.000019: THIRD.- In the case of import and / or export of biological samples for the purpose of
p.000019: investigation, the sponsor must request the corresponding authorization from the ARCSA, which will issue it
p.000019: verifying compliance with the constitutional provisions regarding the protection of
p.000019: genetic resources In order to avoid the loss of quality of the samples that need to be
p.000019: analyzed immediately and that need to be processed outside the country, said sponsor will start
p.000019: the authorization process with at least twenty days before taking the samples. The ARCSA
p.000019: shall
p.000019: national legislation in force.
p.000019: SEVENTH.- The ARCSA must meet all information requirements made by the Ministry of Public Health on
p.000019: clinical trials
p.000019: EIGHTH.- It will be the responsibility of the ARCSA to keep the records of a clinical trial that rest in
...
Health / Motherhood/Family
Searching for indicator family:
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p.000019: to formulate the national health policy, and to regulate, regulate and control all activities related to
p.000019: health, as well as the functioning of the entities of the sector;
p.000019: That, the Constitution of the Republic of Ecuador, in its article 387, numeral 2, indicates that it is
p.000019: State responsibility to promote the generation and production of knowledge, promote
p.000019: scientific and technological research, and enhance ancestral knowledge, in order to contribute to the
p.000019: realization of good living, to sumak kawsay;
p.000019: That, the Universal Declaration on Bioethics and Human Rights approved by the General Conference of the
p.000019: UNESCO in 2005, in its article 19, urges countries to create, promote and support committees of
p.000019: independent, multidisciplinary and pluralistic ethics with a view to assessing ethical, legal,
p.000019: relevant scientific and social, raised by research projects relating to human beings;
p.000019: to provide advice on ethical problems in clinical contexts; and to evaluate the progress of the
p.000019: science and technology;
p.000019: That, the Organic Health Law provides: “Art. 4. The national health authority is the Ministry of
p.000019: Public Health, entity to which the exercise of the
p.000019: informed and in writing, respecting confidentiality;
p.000019: That, the Code of Children and Adolescents, in the article
p.000019: 20 prescribes: “Right to life.- Children and adolescents have the right to life from their
p.000019: conception. It is the obligation of the State, society and the family to ensure, by all means at their disposal, their
p.000019: Survival and development Medical and genetic experiments and manipulations are prohibited from fertilization of
p.000019: ovum until the birth of children and adolescents; and the use of any technique or practice that
p.000019: endanger your life or affect your integrity or integral development. ”;
p.000019: That, the Helsinki Declaration of the World Medical Association - Ethical Principles for
p.000019: Medical Research in Human Beings, in its article 8, indicates that in medical research in beings
p.000019: human, the rights of the person participating in the investigation must always have the primacy over all
p.000019: other interests; and that for such research a prior evaluation and approval by a
p.000019: independent ethics committee;
p.000019: That, the International Ethical Guidelines for Biomedical Research in Human Beings, prepared by the Council of
p.000019: International Medical Sciences Organizations (CIOMS), in collaboration with the World Organization of
p.000019: Health, establishes among its articles that all proposals for research in humans
p.000019: Official Registry - Special Edition Nº 23
p.000019: they must be submitted to a scientific and ethical evaluation committee; and emphasize the importance of
p.000019: individual informed consent in all biomedical research;
p.000019: That, is the attribution and responsibility of the National Agency for Regulation, Control and Surveillance
p.000019: Sanitaria- ARCSA, “approve clinical trials of medications, medical devices. Natural products for use
p.000019: medicinal products and other products subject to registration and sanitary control based on regulations issued by the
...
Health / Physically Disabled
Searching for indicator illness:
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p.000019: Registered automated instruments, copies or certified transcripts after verifying that they are
p.000019: exact copies, microfiche, photographic negatives, magnetic media or microfilm, x-rays, records of
p.000019: subjects and records kept in the pharmacy, in laboratories and in medical-technical departments
p.000019: involved in the clinical study.
p.000019: • Amendment: written description of the change or changes to the research protocol to the researcher's manual
p.000019: and / or informed consent, which does not modify the objectives, the time of treatment and the product in
p.000019: investigation.
p.000019: Official Registry - Special Edition Nº 23
p.000019: • Clinical Trial: is any investigation that is carried out in humans with the intention of
p.000019: discover or verify the clinical, pharmacological and / or any other pharmacodynamic effects of
p.000019: product (s) under investigation and / or identify any adverse reaction to research product (s)
p.000019: and / or to study the absorption, distribution, metabolism and excretion of product (s) under investigation, with
p.000019: The purpose of checking its safety and / or effectiveness. In these Regulations the terms are used interchangeably
p.000019: "Essay" and "study", without there being, for the purpose of this instrument, any difference in its meaning and scope.
p.000019: • Adverse event (EA): any adverse health incident that occurs in a
p.000019: subject or participant in clinical research, to whom a research product has been administered,
p.000019: although it does not necessarily have a causal relationship with the product under study. An adverse event can be, by
p.000019: therefore, any unfavorable and unintended sign (including an abnormal laboratory finding),
p.000019: symptom or illness temporarily associated with the use of a drug or product under investigation, whether or not
p.000019: related to it.
p.000019: • Serious Adverse Event: any event that occurs in the context of a clinical trial, without
p.000019: it is necessarily related to causality with the product under investigation, and that produces: the death of the subject in
p.000019: investigation, put the subject's life at risk, make the subject's hospitalization necessary or prolong his
p.000019: stay, produce permanent or significant disability or disability, or place a
p.000019: Friday, June 30, 2017 - 17
p.000019: commercialization; provide additional information on efficacy, effectiveness and long-term safety (risk-
p.000019: benefit). They are performed under conditions of usual medical practice and in large numbers of subjects during a
p.000019: prolonged period Also known as post-marketing, post-registration or
p.000019: Pharmacovigilance
p.000019: • Inspection: for the purposes of this regulation, the verification or revision action is understood as such
p.000019: developed by the National Health Authority through the National Agency for Regulation, Control and
p.000019: Health Surveillance (ARCSA), to documents, facilities, files, quality assurance systems and
p.000019: Any other resource that ARCSA considers is related to a clinical study.
p.000019: • Nonprofit clinical research: research conducted by researchers without the
p.000019: Participation of the pharmaceutical or pharmaceutical industry that meets the following requirements: 1)
...
Health / Pregnant
Searching for indicator pregnant:
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p.000019: and nationality
p.000019: d l Ecuador, in addition to consent
p.000019: which must be recorded in an individual informed consent document, must be
p.000019: make an enquiry
p.000019: informed. These people may be healthy or suffer
p.000019: common taria
p.000019: prior, which should be favorable to the
p.000019: diseases. The research product will be supplied to the research subjects, or the product used
p.000019: as a control, once your informed consent or that of your legal representative has been obtained, in the
p.000019: If applicable.
p.000019: conduct of the study; and obtain additional approval from the community authorities involved in the case.
p.000019: This approval must be recorded in a document duly signed by these authorities, whose copy will be attached to
p.000019: the approval request procedures for the realization of
p.000019: clinical trial No clinical trials may be conducted in
p.000019: Art. 29.- Clinical trials carried out in older adults, people with disabilities, private persons d
p.000019: freedom and those who suffer from catastrophic diseases and high complexity, because they are considered groups
p.000019: of priority or vulnerable attention, should be of specific interest and limited to those whose
p.000019: nature can only be done in this population group.
p.000019: Art. 30.- In women of reproductive age who have agreed to participate in a clinical study, prior to
p.000019: At the beginning of the confirmation will be made that the participant is not pregnant.
p.000019: Access to and use of an effective contraceptive method during development should be ensured
p.000019: of the clinical trial, which will be provided at no cost by the study sponsor, during the entire time of your
p.000019: participation in it, including subjects in male research.
p.000019: Art. 31.- In case of pregnancy during the clinical trial, the woman will be
p.000019: excluded as subject in investigation; In addition, the study sponsor will monitor the
p.000019: patient and newborn until he has reached at least two (2) years of age. The sponsor
p.000019: must compensate
p.000019: people in voluntary isolation (not contacted).
p.000019: In these clinical studies, sponsors and researchers must develop forms and
p.000019: culturally appropriate means with anthropologists, sociologists and translators, to communicate to
p.000019: Participants in the investigation, all the necessary information regarding the trial and fulfill the
p.000019: standard required in the informed consent process. In addition, in the research protocol
p.000019: the procedure they plan to use to communicate the information to should be described and justified
p.000019: the subjects under investigation.
p.000019: CHAPTER IV
p.000019: OF INFORMED CONSENT IN CLINICAL RESEARCH
p.000019: Art. 34.- Informed consent is the communication process that ends in a dated document
p.000019: and signed by the principal investigator and the participant of a clinical study or its legal representative,
...
p.000019: FOUR.- In the health establishments of the Comprehensive Public Health Network in which they perform
p.000019: clinical trials, direct and indirect costs generated by l
p.000019: counted from the publication of this Ministerial Agreement in the Official Register, the ARCSA
p.000019: will create the National Registry of Clinical Research Centers, which will be subject to the requirements
p.000019: that this Agency
p.000019: Realization of the essay will be covered in full by the sponsor of the same.
p.000019: It was close to the effect.
p.000019: FOUR.- Within one hundred eighty (180) days,
p.000019: All hospital care that is carried out in a public health facility, in
p.000019: the phases of recruitment, execution, and possible complications that occur during or after
p.000019: Once completed, they will be covered by the sponsor of the essay in accordance with the Tariff of Benefits
p.000019: l National Health System in force.
p.000019: These individuals must be included in the agreement signed between the promoter and the health establishment of the Network
p.000019: Comprehensive Public Health.
p.000019: FIFTH.- The incentives received by researchers working in establishments of the Integral Public Network of
p.000019: Health (RPIS) for its services provided, in the execution of a clinical trial, which are developed in a
p.000019: Establishment of this type, outside their working day, must be recorded in the agreement signed by the promoter and the
p.000019: health establishment of the Comprehensive Public Health Network.
p.000019: In the agreement, additionally the authorization of the health establishment for the researcher
p.000019: you can use the facilities of the establishment for the purposes of the clinical trial, outside your working day
p.000019: labor.
p.000019: SIXTH.- Concerning clinical trials in pregnant women and minors will be subject to
p.000019: a specific regulation based on the content of the
p.000019: counted from the publication of this Ministerial Agreement in the Official Register, the ARCSA
p.000019: will create the National Registry of Clinical Trials, which will be subject to the requirements established by the Agency for
p.000019: The effect.
p.000019: FIFTH.- In the term of one hundred eighty (180) days, counted from the publication of this
p.000019: Ministerial Agreement in the Official Registry, the Ministry of Public Health will create the National Repository of
p.000019: Health Research (RENISA).
p.000019: FINAL DISPOSITION
p.000019: On the execution of this Ministerial Agreement that will come into effect as of its publication in the Registry
p.000019: Official, entrust yourself to the National Agency for Regulation, Control and Health Surveillance ARCSA and the Ministry of Health
p.000019: Public
p.000019: Given in the Metropolitan District of Quito on May 19, 2017.
p.000019: f.) Dr. María Verónica Espinosa Serrano, Minister of Public Health.
p.000019: It is a faithful copy of the document that appears in the file of the National Directorate of the General Secretariat, to which I refer
p.000019: if necessary.- I certify it.- Quito a, May 23, 2017.- f.) Illegible, General Secretariat, Ministry of
p.000019: Public health.
p.000019: Official Registry - Special Edition Nº 23 Friday, June 30, 2017 -
p.000019: 19
p.000019: 20 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: Official Registry - Special Edition Nº 23 Friday, June 30, 2017 -
p.000019: twenty-one
p.000019: 22 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: Official Registry - Special Edition Nº 23 Friday, June 30, 2017 -
p.000019: 2. 3
...
Health / patients in emergency situations
Searching for indicator emergencies:
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p.000019: appropriate means for development
p.000019: the Research Ethics Committee in Hu Beings
p.000019: years
p.000019: del est gave, among them, suitable conditions for
p.000019: by the National Health Authority and Good Clinical Practices
p.000019: k) Review the investigator's file making sure it is complete and up to date and identify errors in
p.000019: case of presenting
p.000019: l) Verify that the backups of all types of resources are recorded in the investigator's file
p.000019: adverse events and reactions, during the development of the clinical trial.
p.000019: m) Review the handling of the product under investigation, its provision and storage conditions, in order to
p.000019: verify if the established in the investigation protocol is fulfilled.
p.000019: n) Verify the existence and application of the procedure for receiving, using and returning the
p.000019: products under investigation in clinical research centers.
p.000019: o) Verify if the correct instructions on research subjects have been provided
p.000019: the use, handling, storage and return of the products under investigation.
p.000019: p) Inform the investigator in writing of errors and deviations from the application of the protocol, in case of
p.000019: have them, as well as the measures that must be implemented to prevent them from recurring.
p.000019: product research soul according to its characteristics; appropriate conditions for
p.000019: consultation and training; guarantee of immediate attention before a potential emergency-medical emergency. From
p.000019: there is no capacity to attend emergencies / emergencies in the clinical research center itself, its
p.000019: benefit must be duly guaranteed by means of a contract or agreement with another health facility, without
p.000019: restriction of any type of attention for the study subjects.
p.000019: CHAPTER XIV
p.000019: FROM THE MAIN RESEARCHER
p.000019: Art. 90.- The principal investigator is the professional responsible for conducting the test.
p.000019: clinician in a clinical research center and who leads the research team. According to
p.000019: complexity of the study determined by the ARCSA, the principal investigator must be a health professional
p.000019: with a fourth level degree, related to the area to investigate. These titles must be registered in the
p.000019: National Secretary of Higher Education, Science, Technology and Innovation (SENESCYT) and before the Ministry of
p.000019: Public health.
p.000019: The principal investigator must prove that they have participated in at least one previous clinical trial and
p.000019: have certificates with academic endorsement of training in Good Clinical Practices and Ethics of the
p.000019: Investigation.
p.000019: Official Registry - Special Edition Nº 23
p.000019: Art. 91.- The responsibilities of the principal investigator in the clinical trial are:
p.000019: a) Know in detail the research protocol and all available information about the product
p.000019: in research.
p.000019: b) Know and comply with Good Clinical Practices and applicable national health regulations.
p.000019: c) Obtain, prior to the start of the clinical trial, the letter of declaration of institutional interest of
p.000019: execution of the study, signed by the legal representative of the health establishment in which
p.000019: will develop the same.
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000019: which must be recorded in an individual informed consent document, must be
p.000019: make an enquiry
p.000019: informed. These people may be healthy or suffer
p.000019: common taria
p.000019: prior, which should be favorable to the
p.000019: diseases. The research product will be supplied to the research subjects, or the product used
p.000019: as a control, once your informed consent or that of your legal representative has been obtained, in the
p.000019: If applicable.
p.000019: conduct of the study; and obtain additional approval from the community authorities involved in the case.
p.000019: This approval must be recorded in a document duly signed by these authorities, whose copy will be attached to
p.000019: the approval request procedures for the realization of
p.000019: clinical trial No clinical trials may be conducted in
p.000019: Art. 29.- Clinical trials carried out in older adults, people with disabilities, private persons d
p.000019: freedom and those who suffer from catastrophic diseases and high complexity, because they are considered groups
p.000019: of priority or vulnerable attention, should be of specific interest and limited to those whose
p.000019: nature can only be done in this population group.
p.000019: Art. 30.- In women of reproductive age who have agreed to participate in a clinical study, prior to
p.000019: At the beginning of the confirmation will be made that the participant is not pregnant.
p.000019: Access to and use of an effective contraceptive method during development should be ensured
p.000019: of the clinical trial, which will be provided at no cost by the study sponsor, during the entire time of your
p.000019: participation in it, including subjects in male research.
p.000019: Art. 31.- In case of pregnancy during the clinical trial, the woman will be
p.000019: excluded as subject in investigation; In addition, the study sponsor will monitor the
p.000019: patient and newborn until he has reached at least two (2) years of age. The sponsor
p.000019: must compensate
p.000019: people in voluntary isolation (not contacted).
p.000019: In these clinical studies, sponsors and researchers must develop forms and
p.000019: culturally appropriate means with anthropologists, sociologists and translators, to communicate to
p.000019: Participants in the investigation, all the necessary information regarding the trial and fulfill the
p.000019: standard required in the informed consent process. In addition, in the research protocol
p.000019: the procedure they plan to use to communicate the information to should be described and justified
p.000019: the subjects under investigation.
p.000019: CHAPTER IV
p.000019: OF INFORMED CONSENT IN CLINICAL RESEARCH
p.000019: Art. 34.- Informed consent is the communication process that ends in a dated document
p.000019: and signed by the principal investigator and the participant of a clinical study or its legal representative,
p.000019: when appropriate, who should be able to express their opinion freely and without coercion. The
...
p.000019: informed and will sign as witnesses two people who e
p.000019: l) L li ertad que the subject in investigation of
p.000019: study participant choose, as long as they have no conflict of interest with the research that was developed
p.000019: It will be linked and not linked in any way with the research team.
p.000019: Art. 37.- The consent document informs or any other informative material, that in relation
p.000019: to the study be provided to the subjects under investigation must be previously reviewed and approved by a
p.000019: Committee of Research Ethics in Human Beings, recognized by the Ministry of Public Health.
p.000019: Art. 38.- The informed consent document may not contain any expression that gives rise to
p.000019: that the subject who consents to it, exempts the sponsor, researcher or his or her responsibility
p.000019: representatives before any responsibility for negligence, or for risks derived from the clinical trial.
p.000019: Art. 39.- The informed consent document for clinical research must contain the following (Annex 4):
p.000019: a) Clear information that the participant will be part of a study that may or may not have
p.000019: positive results.
p.000019: b) The justification and objective of the clinical trial.
p.000019: c) All procedures to be performed, clearly specifying the aspects that
p.000019: Be experimental and your purpose.
p.000019: revoke your mind at any time and stop participating in the study, for which the researcher
p.000019: it must ensure the proper process for the exclusion of the participant while preserving their safety, and without affecting their
p.000019: access to the medical care you require.
p.000019: m) The measures to be taken to guarantee the privacy and confidentiality of the
p.000019: information of the subjects under investigation.
p.000019: n) If biological samples are required as part of the research protocol, it must be specified
p.000019: that they will serve exclusively for the essay for which the subject gives his consent.
p.000019: Additional express consent will be required, in the case of consulting the participant about their consent
p.000019: for the future use of these samples, for other investigations defined as priorities for the Authority
p.000019: National Health. This last document should indicate how long the samples will be stored, where and
p.000019: under what custodian This new investigation must comply with all the requirements to carry out a
p.000019: health research, and obtain the approval of a CEISH and the National Health Authority prior to its
p.000019: execution.
p.000019: o) The obligation of the investigator to inform the subject under investigation in due course and timely
p.000019: the product under investigation, although the information could affect your decision to continue participating in the
p.000019: clinical trial
p.000019: Official Registry - Special Edition Nº 23
p.000019: p) The free delivery of the product under investigation, the time during which the
p.000019: same, the complementary exams that are required for research purposes and the
p.000019: standardized procedure, which according to the study protocol, research subjects should receive.
p.000019: q) The participant's right to obtain additional information, through the researcher, on
...
p.000019: that there is no therapeutic alternative available for the patient's disease and that the risk for
p.000019: person is not older than the one faced by the disease he suffers.
p.000019: b) The informed consent of the patient or his legal representative, when applicable.
p.000019: c) That the producer of the medicine agrees with the free endowment of the drug, after the evaluation
p.000019: Case clinic and consultation of the attending physician
p.000019: Art. 57.- The doctor responsible for applying the medication under the conditions of this Chapter shall notify the
p.000019: ARCSA the results of it.
p.000019: Official Registry - Special Edition Nº 23
p.000019: Art. 58.- The use in exceptional conditions of a drug under investigation, to treat
p.000019: patients in conditions in which their lives are in danger, it is a process that does not correspond to a clinical trial of
p.000019: investigational medications, and will be performed when a doctor, under your responsibility,
p.000019: justify with a clinical report the use of the medicine because it considers its
p.000019: use. The ARCSA must authorize the use of any investigational medication under exceptional conditions.
p.000019: CHAPTER VIII
p.000019: OF THE REGISTRATION AND PUBLICATION BASE OF CLINICAL TRIALS
p.000019: Art. 59.- The ARCSA will create and maintain the National Registry of Clinical Trials, observing the requirements of the
p.000019: Primary Registry of the World Health Organization. This record will be a publicly accessible database. The
p.000019: Agency will provide access to this registry and additional information that the Ministry of Public Health requires
p.000019: for the purpose of monitoring and control of the investigation.
p.000019: Art. 60.- In the case of publication of results of a clinical trial developed in Ecuador in
p.000019: national or international scientific journals, the researcher will send a mandatory
p.000019: copy of said publication to the ARCSA and the Ministry of Public Health. Such publications in any case
p.000019: will contain identification data of the study subjects.
p.000019: Friday, June 30, 2017 - 11
p.000019: Art. 63.- CEISH members must prove knowledge and experience in relation to ethical aspects,
p.000019: methodological and legal clinical research, good clinical practices and clinical practice
p.000019: welfare. They must excuse their participation in the evaluation of research projects in which they could have
p.000019: interest conflict.
p.000019: Art. 64.- The CEISH shall be governed by conventions, declarations, instruments and norms.
p.000019: internationals related to biomedical and bioethical research, due to sanitary regulations
p.000019: specific current and the regulations issued by the National Health Authority.
p.000019: SPONSOR CHAPTER X
p.000019: Art. 65.- The sponsor is the individual, company, institution or organization, including
p.000019: academics, with legal representation in the country, responsible for financing, administration,
p.000019: initiation, development, monitoring and closure of a clinical trial.
p.000019: Art. 66.- In cases in which the insurance policy does not cover all damages, it will be the sponsor who solvent
p.000019: the expenses for the damage that the subjects under investigation have on their health. In addition, the sponsor will be
...
p.000019: Art. 69.- If the sponsor does not have its headquarters in Ecuador, it must necessarily have a representative
p.000019: Legal domiciled in the country, which must be a Contract Research Organization registered in the
p.000019: ARCSA The Contract Research Organization must additionally fulfill the functions that are
p.000019: delegates by the sponsor in the contract signed for this purpose.
p.000019: Art. 70.- The sponsor must guarantee the confidentiality of the data obtained from the subjects under investigation and
p.000019: the protection and security of the participants in it, through the implementation of a system of
p.000019: Safety monitoring and reports of adverse reactions that are disseminated worldwide.
p.000019: Art. 71.- In addition to the insurance policy that each clinical trial must have, the sponsor
p.000019: guarantee the provision of free medical care, until the resolution of health problems that may arise
p.000019: appear in the subjects under investigation, if these problems arise as a result of their
p.000019: Participation in the study.
p.000019: 12 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: Art. 72.- The sponsor of a clinical trial will be responsible for guaranteeing the
p.000019: implementation of a quality assurance and control system, through operational procedures
p.000019: standard, to ensure that studies are carried out in compliance with Good Clinical Practices. These
p.000019: Procedures must be documented.
p.000019: Art. 73.- The sponsor will verify that all the documentation corresponding to the essay
p.000019: clinic is properly detailed, ensuring that the data generated is correctly
p.000019: communicated to the ARCSA, in the corresponding cases or when required by the Agency. Shall
p.000019: guarantee access to all documentation requested by ARCSA in relation to clinical trials under
p.000019: your responsibility
p.000019: Art. 74.- The sponsor's functions in relation to a clinical trial, in addition to those described above, are
p.000019: the following:
p.000019: a) Select and hire qualified researchers for their training, training and / or experience
p.000019: to participate in a clinical trial, as well as select clinical research centers
p.000019: that have all the necessary resources for the clinical trial to be developed, following the
p.000019: Good Clinical Practices and guaranteeing the safety of the subject under investigation.
p.000019: i) Timely inform the participants of the trial, the researchers, the Committee of
p.000019: Research Ethics in Human Beings and ARCSA on new findings and updated information regarding the
p.000019: product or products under investigation.
p.000019: j) Notify ARCSA of suspected serious adverse reactions or events
p.000019: serious adverse effects that may affect the benefit-risk ratio of the clinical trial, taking urgent measures to
p.000019: security to protect test subjects.
p.000019: k) Provide free of charge to the study participants the product under investigation and the
p.000019: auxiliary medications, and provide coverage for the complementary exams that are required during the
p.000019: clinical trial development.
p.000019: l) Designate a national monitor that will monitor the development of the clinical trial and have a
p.000019: appropriate monitoring system.
p.000019: m) Send timely monitoring reports to the clinical trial to the ARCSA.
p.000019: n) Submit a progress report to ARCSA at least once a year and when required by said Agency
p.000019: on and unfolding the clinical trial, as well as
...
p.000019: with the reference safety information of the product under investigation.
p.000019: GENERAL DISPOSITION
p.000019: FIRST.- The National Agency for Regulation, Control and Health Surveillance - ARCSA will verify in
p.000019: the entire national territory, compliance with the suspension or cancellation of trials
p.000019: clinicians that run in the country and if necessary will request support from their Zonal Coordinations.
p.000019: SECOND.- If necessary, within the approval, control and surveillance processes of a clinical trial, the
p.000019: ARCSA will request additional information from the sponsor described in this instrument.
p.000019: THIRD.- In the case of import and / or export of biological samples for the purpose of
p.000019: investigation, the sponsor must request the corresponding authorization from the ARCSA, which will issue it
p.000019: verifying compliance with the constitutional provisions regarding the protection of
p.000019: genetic resources In order to avoid the loss of quality of the samples that need to be
p.000019: analyzed immediately and that need to be processed outside the country, said sponsor will start
p.000019: the authorization process with at least twenty days before taking the samples. The ARCSA
p.000019: shall
p.000019: national legislation in force.
p.000019: SEVENTH.- The ARCSA must meet all information requirements made by the Ministry of Public Health on
p.000019: clinical trials
p.000019: EIGHTH.- It will be the responsibility of the ARCSA to keep the records of a clinical trial that rest in
p.000019: said Agency, therefore, when the members of the Technical Advisory Committee on Clinical Research, require
p.000019: analyze the files, they will have access to them in the facilities of the ARCSA.
p.000019: TRANSITORY DISPOSITIONS
p.000019: FIRST.- Within one hundred and twenty (120) days, counted from the publication of this
p.000019: Ministerial Agreement in the Official Registry, the National Agency for Regulation, Control and Surveillance
p.000019: Healthcare - ARCSA will prepare the “Guide of procedures for conducting clinical trials in Ecuador”
p.000019: and other technical and administrative instructions necessary for the application of this Regulation, including
p.000019: the instructions for the import and export of biological samples for research purposes and
p.000019: health care
p.000019: SECOND.- Within a term of one hundred eighty (180) days, as of the publication of this Agreement
p.000019: Ministerial in the Registry Office, the National Registry of Research Organizations will be created by
p.000019: Contract, which will be in charge of the ARCSA, for which it will coordinate with the National Directorate of Health Intelligence
p.000019: of the Ministry of Public Health.
p.000019: respond to the requirement within twenty (20) days,
p.000019: THIRD RA.- Within one hundred eighty (180) days,
p.000019: counted from the date you receive the request.
p.000019: FOUR.- In the health establishments of the Comprehensive Public Health Network in which they perform
p.000019: clinical trials, direct and indirect costs generated by l
p.000019: counted from the publication of this Ministerial Agreement in the Official Register, the ARCSA
p.000019: will create the National Registry of Clinical Research Centers, which will be subject to the requirements
p.000019: that this Agency
p.000019: Realization of the essay will be covered in full by the sponsor of the same.
p.000019: It was close to the effect.
p.000019: FOUR.- Within one hundred eighty (180) days,
p.000019: All hospital care that is carried out in a public health facility, in
...
Social / Age
Searching for indicator age:
(return to top)
p.000019: granted by his
p.000019: voluntarily participate in a clinical trial, who Art. 33.- In clinical studies
p.000019: made in villages
p.000019: must be previously informed about it,
p.000019: and nationality
p.000019: d l Ecuador, in addition to consent
p.000019: which must be recorded in an individual informed consent document, must be
p.000019: make an enquiry
p.000019: informed. These people may be healthy or suffer
p.000019: common taria
p.000019: prior, which should be favorable to the
p.000019: diseases. The research product will be supplied to the research subjects, or the product used
p.000019: as a control, once your informed consent or that of your legal representative has been obtained, in the
p.000019: If applicable.
p.000019: conduct of the study; and obtain additional approval from the community authorities involved in the case.
p.000019: This approval must be recorded in a document duly signed by these authorities, whose copy will be attached to
p.000019: the approval request procedures for the realization of
p.000019: clinical trial No clinical trials may be conducted in
p.000019: Art. 29.- Clinical trials carried out in older adults, people with disabilities, private persons d
p.000019: freedom and those who suffer from catastrophic diseases and high complexity, because they are considered groups
p.000019: of priority or vulnerable attention, should be of specific interest and limited to those whose
p.000019: nature can only be done in this population group.
p.000019: Art. 30.- In women of reproductive age who have agreed to participate in a clinical study, prior to
p.000019: At the beginning of the confirmation will be made that the participant is not pregnant.
p.000019: Access to and use of an effective contraceptive method during development should be ensured
p.000019: of the clinical trial, which will be provided at no cost by the study sponsor, during the entire time of your
p.000019: participation in it, including subjects in male research.
p.000019: Art. 31.- In case of pregnancy during the clinical trial, the woman will be
p.000019: excluded as subject in investigation; In addition, the study sponsor will monitor the
p.000019: patient and newborn until he has reached at least two (2) years of age. The sponsor
p.000019: must compensate
p.000019: people in voluntary isolation (not contacted).
p.000019: In these clinical studies, sponsors and researchers must develop forms and
p.000019: culturally appropriate means with anthropologists, sociologists and translators, to communicate to
p.000019: Participants in the investigation, all the necessary information regarding the trial and fulfill the
p.000019: standard required in the informed consent process. In addition, in the research protocol
p.000019: the procedure they plan to use to communicate the information to should be described and justified
p.000019: the subjects under investigation.
p.000019: CHAPTER IV
p.000019: OF INFORMED CONSENT IN CLINICAL RESEARCH
p.000019: Art. 34.- Informed consent is the communication process that ends in a dated document
p.000019: and signed by the principal investigator and the participant of a clinical study or its legal representative,
p.000019: when appropriate, who should be able to express their opinion freely and without coercion. The
p.000019: Participant or his legal representative, through informed consent, will express their willingness to be part of the
p.000019: I study with full
p.000019: 8 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: knowledge of its purpose, the procedures, benefits and risks to which it will be submitted, the
p.000019: possible treatment alternatives and the grounds for exclusion from the investigation, being able to revoke
p.000019: Your consent at any time.
...
p.000019: Sponsor will guarantee the monitoring of the subject for at least two (2) years.
p.000019: Art. 35.- The principal investigator or a delegate thereof who is part of the research team,
p.000019: inform in writing and verbally the subject under investigation or his legal representative, when
p.000019: appropriate, regarding the risks, discomforts and possible benefits of the study in which it is raised
p.000019: your participation, using simple, clear and warm terms.
p.000019: Art. 36.- In the case of illiterate persons, their fingerprint will be registered in the document of
p.000019: consent
p.000019: d) Selection criteria, exclusion and number of subjects under investigation.
p.000019: e) Duration, side effects, direct benefits of participation in the clinical trial, the expected risks
p.000019: for the subject, including possible adverse reactions, risks to the health and well-being of the couple or
p.000019: spouse. Possible benefits for the community or society.
p.000019: f) Alternative treatments that could be beneficial for the subject under investigation.
p.000019: g) Point out that the participation of the subject in the clinical trial is voluntary and that their decision to participate
p.000019: or not the study will not influence in any way the health care process that the subject requires in
p.000019: investigation.
p.000019: h) Information about the product or products under investigation.
p.000019: i) Causes that could cause the suspension of the subject's participation in the study.
p.000019: j) Point out the potential risks in case of pregnancy and the importance of using
p.000019: an effective contraceptive method, if the subjects that are part of the study are of age
p.000019: reproductive
p.000019: k) The responsibilities of the research team.
p.000019: informed and will sign as witnesses two people who e
p.000019: l) L li ertad que the subject in investigation of
p.000019: study participant choose, as long as they have no conflict of interest with the research that was developed
p.000019: It will be linked and not linked in any way with the research team.
p.000019: Art. 37.- The consent document informs or any other informative material, that in relation
p.000019: to the study be provided to the subjects under investigation must be previously reviewed and approved by a
p.000019: Committee of Research Ethics in Human Beings, recognized by the Ministry of Public Health.
p.000019: Art. 38.- The informed consent document may not contain any expression that gives rise to
p.000019: that the subject who consents to it, exempts the sponsor, researcher or his or her responsibility
p.000019: representatives before any responsibility for negligence, or for risks derived from the clinical trial.
p.000019: Art. 39.- The informed consent document for clinical research must contain the following (Annex 4):
p.000019: a) Clear information that the participant will be part of a study that may or may not have
p.000019: positive results.
p.000019: b) The justification and objective of the clinical trial.
p.000019: c) All procedures to be performed, clearly specifying the aspects that
p.000019: Be experimental and your purpose.
p.000019: revoke your mind at any time and stop participating in the study, for which the researcher
p.000019: it must ensure the proper process for the exclusion of the participant while preserving their safety, and without affecting their
...
Social / Child
Searching for indicator children:
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p.000019: competent, subject to bioethical rights and rights, prior
p.000019: That, the aforementioned Constitution of the Republic of the United States provides, in article 361, that the State shall exercise the
p.000019: Rectory of the National Health System through the National Health Authority, which will be responsible
p.000019: to formulate the national health policy, and to regulate, regulate and control all activities related to
p.000019: health, as well as the functioning of the entities of the sector;
p.000019: That, the Constitution of the Republic of Ecuador, in its article 387, numeral 2, indicates that it is
p.000019: State responsibility to promote the generation and production of knowledge, promote
p.000019: scientific and technological research, and enhance ancestral knowledge, in order to contribute to the
p.000019: realization of good living, to sumak kawsay;
p.000019: That, the Universal Declaration on Bioethics and Human Rights approved by the General Conference of the
p.000019: UNESCO in 2005, in its article 19, urges countries to create, promote and support committees of
p.000019: independent, multidisciplinary and pluralistic ethics with a view to assessing ethical, legal,
p.000019: relevant scientific and social, raised by research projects relating to human beings;
p.000019: to provide advice on ethical problems in clinical contexts; and to evaluate the progress of the
p.000019: science and technology;
p.000019: That, the Organic Health Law provides: “Art. 4. The national health authority is the Ministry of
p.000019: Public Health, entity to which the exercise of the
p.000019: informed and in writing, respecting confidentiality;
p.000019: That, the Code of Children and Adolescents, in the article
p.000019: 20 prescribes: “Right to life.- Children and adolescents have the right to life from their
p.000019: conception. It is the obligation of the State, society and the family to ensure, by all means at their disposal, their
p.000019: Survival and development Medical and genetic experiments and manipulations are prohibited from fertilization of
p.000019: ovum until the birth of children and adolescents; and the use of any technique or practice that
p.000019: endanger your life or affect your integrity or integral development. ”;
p.000019: That, the Helsinki Declaration of the World Medical Association - Ethical Principles for
p.000019: Medical Research in Human Beings, in its article 8, indicates that in medical research in beings
p.000019: human, the rights of the person participating in the investigation must always have the primacy over all
p.000019: other interests; and that for such research a prior evaluation and approval by a
p.000019: independent ethics committee;
p.000019: That, the International Ethical Guidelines for Biomedical Research in Human Beings, prepared by the Council of
p.000019: International Medical Sciences Organizations (CIOMS), in collaboration with the World Organization of
p.000019: Health, establishes among its articles that all proposals for research in humans
p.000019: Official Registry - Special Edition Nº 23
p.000019: they must be submitted to a scientific and ethical evaluation committee; and emphasize the importance of
p.000019: individual informed consent in all biomedical research;
p.000019: That, is the attribution and responsibility of the National Agency for Regulation, Control and Surveillance
p.000019: Sanitaria- ARCSA, “approve clinical trials of medications, medical devices. Natural products for use
p.000019: medicinal products and other products subject to registration and sanitary control based on regulations issued by the
p.000019: Ministry of Public Health ”, as indicated in article 10, number 8, of the Decree
p.000019: Executive No. 1290 published in the Supplement to Official Registry No. 788 of September 13, 2012;
p.000019: That, by Executive Decree No. 1293 published in the Supplement of the Official Registry No. 934 of January 31
...
Social / Linguistic Proficiency
Searching for indicator language:
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p.000019: clinical trial
p.000019: z) The sponsor's sworn commitment to deliver the final report of the essay to the ARCSA.
p.000019: aa) Copy of the civil liability insurance policy issued by an established insurance company
p.000019: in Ecuador, empowered for this purpose. The policy will cover the responsibilities of all those involved in the
p.000019: research, as well as those of the clinical research center where the clinical trial is conducted. The
p.000019: coverage should cover the execution of the clinical trial
p.000019: Official Registry - Special Edition Nº 23
p.000019: and it will be extended at least one (1) year after its completion, in order to cover the consequences that are demonstrated to be
p.000019: derived from the clinical trial in question. After passing an essay, if it lasts more than one (1) year, the
p.000019: promoter will present to the ARCSA a commitment to renew the policy, at least three (3) months of
p.000019: anticipation of its expiration; and present the renewed policy once it is issued.
p.000019: The civil liability policy must be subject to the provisions of the Monetary Organic Code and
p.000019: Financial, Book III General Insurance Law, Commercial Code and other regulations in force on the subject; Y
p.000019: It will contain at least the following: the title of the study, duration of the study, coverage of care
p.000019: required, types of insured risks, covered clinical tests, limit value of coverage to the insured by
p.000019: event and the amount of the policy, which will be determined according to the risk of the clinical investigation that appears in the
p.000019: approved protocol.
p.000019: Art. 9.- For the approval of the clinical trial, the ARCSA will request that all documents be presented in
p.000019: Spanish language. Documents prepared in another language must be submitted with an official translation,
p.000019: duly apostilled or legalized, as appropriate, in the country of origin. Additionally, the ARCSA
p.000019: You may request some documents in your original language for translation review or for the purposes that
p.000019: The Agency deems pertinent.
p.000019: Friday, June 30, 2017 - 5
p.000019: of the five (5) days after receipt of the documentation, so that within thirty (30)
p.000019: days counted from the receipt of the notification, correct the observations made. Of not existing
p.000019: Answer will be automatically terminated.
p.000019: Art. 13.- All modifications presented within a clinical trial must be authorized.
p.000019: by the ARCSA. Those amendments related to the Protocol, the Investigator Manual and the Consent
p.000019: Informed, they must be previously approved by the Research Ethics Committee on Human Beings that approved the
p.000019: research protocol.
p.000019: Art. 14.- Requests for modifications to authorized clinical trials will receive a response.
p.000019: favorable or unfavorable of the ARCSA in a term of forty-five (45) days, counted from
p.000019: the presentation of the procedure. In exceptional cases, if the sponsor justifies with documentation of
p.000019: adequate support that the clinical trial modification will imply a benefit for the patient, the time of
p.000019: ARCSA analysis for said modification will be a maximum of fifteen (5) days.
p.000019: Art. 15.- The ARCSA does not increase amendments that modify the product under investigation, the
p.000019: treatment time, nor the objectives of the study. As long as a change or requested is not approved, it
p.000019: it cannot be implemented and the study must follow its execution
p.000019: join the conditions with which he was authorized, always
p.000019: Art. 10.- Once the ARCSA verifies that the request
p.000019: and when it does not imply damage to the health or life of the subjects
p.000019: and the documentation presented c mplen with all l s
p.000019: In est gación.
...
p.000019: subject under investigation and there is no therapeutic option that can replace the study treatment
p.000019: in the market and until the product is marketed in the country.
p.000019: Art. 40.- In cases where the use of placebo is authorized in a clinical study, prior to obtaining the
p.000019: informed consent of the participants, they will be informed with sufficient time and clearly in what
p.000019: This process consists.
p.000019: The use of placebo should be considered in cases where there is no therapy, intervention,
p.000019: medication or procedure of proven efficacy for the problem investigated; and in others it must be analyzed
p.000019: on a case-by-case basis by the CEISH and by the ARCSA, in order to minimize risks and not affect the safety of
p.000019: subjects under investigation, ensuring that they do not run additional risks, serious adverse effects or damages
p.000019: irreversible as a result of not receiving the best proven intervention.
p.000019: Art. 45.- In the event that the product under investigation is manufactured in the country, the ARCSA will carry out inspections.
p.000019: to verify the manufacturing process.
p.000019: Art. 46.- The laboratory manufacturing the product under investigation must comply with the Standards of
p.000019: Good Manufacturing Practices established by national regulations for the elaboration of a product
p.000019: pharmacological, presenting the different quality and stability certifications in the product file
p.000019: of the drug.
p.000019: The product under investigation must be properly labeled on the primary container with ink
p.000019: indelible in Spanish language, indicating at least the data that identify the sponsor, to the clinical trial
p.000019: and to the product under investigation and its expiration date, protocol code, product code,
p.000019: lot number, number of units and dosage form, route of administration, storage conditions,
p.000019: conservation and use thereof. Additionally, the labeling must specify the phrases “Prohibited its
p.000019: sale ”and“ product for exclusive research use ”. In the case of primary packaging
p.000019: 10 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: that because of its space they do not allow to establish this information, it will be printed in a secondary container.
p.000019: Art. 47.- In the review of the clinical trial, the ARCSA will analyze how the management of the
p.000019: product under investigation, according to the Standards of Good Manufacturing Practices and studying, between
p.000019: Other points, control of records, packaging, labeling and coding, procedure for
p.000019: dispensing, storage and location thereof.
p.000019: Art. 48.- Surplus and / or expired research products at the conclusion or suspension of the trial
p.000019: clinical, should be destroyed by the sponsor or his delegate, according to the procedure established in the
p.000019: corresponding regulations.
p.000019: Leftover reagents not used in the investigation that are in good condition may be
p.000019: donated, in accordance with current regulations.
p.000019: Art. 49.- It may be exempted from the destruction referred to in the previous article to the products in
p.000019: investigation, prior authorization of the ARCSA, in the following cases:
p.000019: a) When the product is not expired and can be used for exceptional cases in patients whose
p.000019: Life is at risk.
...
Social / Literacy
Searching for indicator illiterate:
(return to top)
p.000019: Participant or his legal representative, through informed consent, will express their willingness to be part of the
p.000019: I study with full
p.000019: 8 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: knowledge of its purpose, the procedures, benefits and risks to which it will be submitted, the
p.000019: possible treatment alternatives and the grounds for exclusion from the investigation, being able to revoke
p.000019: Your consent at any time.
p.000019: The withdrawal of the informed consent of the participant will be accepted at any time, ensuring that
p.000019: their disengagement from the study does not affect or endanger the health of the subject under investigation.
p.000019: If a conflict of opinion arises between the subject under investigation and his legal representative, regarding his
p.000019: Participation in the clinical trial, at any time during or before the study, will exclude
p.000019: subject provided that such exclusion does not jeopardize your health.
p.000019: In any case of exclusion of a participant from a clinical trial, the investigator and the
p.000019: Sponsor will guarantee the monitoring of the subject for at least two (2) years.
p.000019: Art. 35.- The principal investigator or a delegate thereof who is part of the research team,
p.000019: inform in writing and verbally the subject under investigation or his legal representative, when
p.000019: appropriate, regarding the risks, discomforts and possible benefits of the study in which it is raised
p.000019: your participation, using simple, clear and warm terms.
p.000019: Art. 36.- In the case of illiterate persons, their fingerprint will be registered in the document of
p.000019: consent
p.000019: d) Selection criteria, exclusion and number of subjects under investigation.
p.000019: e) Duration, side effects, direct benefits of participation in the clinical trial, the expected risks
p.000019: for the subject, including possible adverse reactions, risks to the health and well-being of the couple or
p.000019: spouse. Possible benefits for the community or society.
p.000019: f) Alternative treatments that could be beneficial for the subject under investigation.
p.000019: g) Point out that the participation of the subject in the clinical trial is voluntary and that their decision to participate
p.000019: or not the study will not influence in any way the health care process that the subject requires in
p.000019: investigation.
p.000019: h) Information about the product or products under investigation.
p.000019: i) Causes that could cause the suspension of the subject's participation in the study.
p.000019: j) Point out the potential risks in case of pregnancy and the importance of using
p.000019: an effective contraceptive method, if the subjects that are part of the study are of age
p.000019: reproductive
p.000019: k) The responsibilities of the research team.
p.000019: informed and will sign as witnesses two people who e
p.000019: l) L li ertad que the subject in investigation of
p.000019: study participant choose, as long as they have no conflict of interest with the research that was developed
p.000019: It will be linked and not linked in any way with the research team.
p.000019: Art. 37.- The consent document informs or any other informative material, that in relation
...
Social / Marital Status
Searching for indicator single:
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p.000019: CHAPTER I
p.000019: PURPOSE AND SCOPE
p.000019: Art. 1.- Purpose.- The purpose of this Regulation is to regulate the approval, execution, monitoring,
p.000019: surveillance and control of clinical trials in Ecuador, which are carried out with medications,
p.000019: biological products and processed natural products for medicinal use.
p.000019: For the purposes of this Regulation, the terms "trial" and "study" shall be used interchangeably.
p.000019: mainly the therapeutic benefits and the risks and inconveniences for the test subject and
p.000019: for public health.
p.000019: Art. 6.- For the realization of a clinical trial in Ecuador it is required that every natural person or
p.000019: legal, public, private, national or foreign that is sponsor of the realization of the essay, request the
p.000019: prior approval to the National Agency for Regulation, Control and Health Surveillance - ARCSA.
p.000019: Art. 7.- The ARCSA will verify and inspect compliance with legal, ethical and
p.000019: methodologies for the development of the clinical trial in the country, before, during and after it
p.000019: perform, as well as all aspects related to research technology.
p.000019: Art. 8.- To authorize a clinical trial, ARCSA will request the sponsor of the study to
p.000019: presentation, at least of the following documentation:
p.000019: 4 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: a) A descriptive sheet of the clinical trial (Annex 1.)
p.000019: b) The approval of the clinical trial protocol by a Research Ethics Committee in Beings
p.000019: Humans (CEISH), officially recognized by the Ministry of Public Health.
p.000019: c) In the cases that apply, the delegation of the sponsor for the development of the trial
p.000019: clinical in the country to a single Contract Research Organization, through a contract or agreement legalized in
p.000019: the one that states the obligations of each of the parties.
p.000019: d) The research protocol.
p.000019: e) The researcher's manual, as established in the Good Clinical Practices.
p.000019: f) The corresponding informed consent form to which the
p.000019: version of the research protocol presented, which has been previously approved by a Committee of
p.000019: Research Ethics in Human Beings.
p.000019: g) The pharmacological report on the marketing approval of the product under investigation
p.000019: issued by the ARCSA, if it were the case of post-marketing studies.
p.000019: h) The letters of declaration of institutional interest and
p.000019: to show experience in the specialty being studied; and, development training of
p.000019: clinical trials, Good Clinical Practices and related subjects.
p.000019: m) The schedule of the study to be carried out in the country.
p.000019: n) A certificate of the quality management system of the clinical laboratory or of the institution in the
p.000019: that is the clinical laboratory that will participate in the study.
p.000019: o) The detail of the product under investigation and other medicines to be used in the test,
p.000019: according to the model in Annex 2 of these Regulations, as well as the label of the product under investigation
p.000019: and packing.
p.000019: p) Health risk assessment reports in the previous phases of the studies (Phase I, II and III), for
p.000019: that the ARCSA establish the risk-benefit balance of the product under investigation.
...
p.000019: interest conflict.
p.000019: Art. 64.- The CEISH shall be governed by conventions, declarations, instruments and norms.
p.000019: internationals related to biomedical and bioethical research, due to sanitary regulations
p.000019: specific current and the regulations issued by the National Health Authority.
p.000019: SPONSOR CHAPTER X
p.000019: Art. 65.- The sponsor is the individual, company, institution or organization, including
p.000019: academics, with legal representation in the country, responsible for financing, administration,
p.000019: initiation, development, monitoring and closure of a clinical trial.
p.000019: Art. 66.- In cases in which the insurance policy does not cover all damages, it will be the sponsor who solvent
p.000019: the expenses for the damage that the subjects under investigation have on their health. In addition, the sponsor will be
p.000019: responsible for the economic damages arising as a result of the clinical trial.
p.000019: Art. 67 - If the sponsor is an individual who investigates
p.000019: CHAPTER IX ba or with time with the academy, this will be the one that
p.000019: hire
p.000019: the insurance policy for the risks arising from the
p.000019: OF THE RESEARCH ETHICS COMMITTEES IN HUMAN BEINGS
p.000019: research qu
p.000019: perform.
p.000019: Art. 61.-
p.000019: The
p.000019: Committees of
p.000019: Ethics of
p.000019: Research on
p.000019: Art. 6 .- All sponsors, without prejudice to their responsibility, may delegate a part or the
p.000019: totality of
p.000019: Human Beings, CEISH, are organs linked to a
p.000019: its functions to a single Research Organization by
p.000019: public or private institution, responsible for approving
p.000019: Contract registered in the ARCSA.
p.000019: the investigations involving human beings
p.000019: or that use biological samples. Any clinical trial protocol carried out in the country, before
p.000019: If it begins its execution, it must first be approved by a Research Ethics Committee on Human Beings and
p.000019: then it will be submitted to the approval of the ARCSA.
p.000019: Art. 62.- Within their functions, the CEISH will carry out the ethical, methodological and legal evaluation
p.000019: of clinical research in order to ensure the protection of rights, security and
p.000019: welfare of the subjects under investigation. The CEISH must evaluate the clinical research protocol and
p.000019: Other study documents such as informed consent, research product manual, manual
p.000019: of the researcher and ensure the follow-up of the studies approved during its development, through the
p.000019: Implementation of monitoring mechanisms according to the inherent risk of clinical research.
p.000019: The ethical evaluation carried out by the CEISH of the clinical trial protocols should be oriented, between
p.000019: others, for the principles of transparency and impartiality and must be expressed in a report justifying the
p.000019: evaluation carried out
p.000019: Art. 69.- If the sponsor does not have its headquarters in Ecuador, it must necessarily have a representative
p.000019: Legal domiciled in the country, which must be a Contract Research Organization registered in the
...
Social / Property Ownership
Searching for indicator property:
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p.000019: investigation, put the subject's life at risk, make the subject's hospitalization necessary or prolong his
p.000019: stay, produce permanent or significant disability or disability, or place a
p.000019: Friday, June 30, 2017 - 17
p.000019: commercialization; provide additional information on efficacy, effectiveness and long-term safety (risk-
p.000019: benefit). They are performed under conditions of usual medical practice and in large numbers of subjects during a
p.000019: prolonged period Also known as post-marketing, post-registration or
p.000019: Pharmacovigilance
p.000019: • Inspection: for the purposes of this regulation, the verification or revision action is understood as such
p.000019: developed by the National Health Authority through the National Agency for Regulation, Control and
p.000019: Health Surveillance (ARCSA), to documents, facilities, files, quality assurance systems and
p.000019: Any other resource that ARCSA considers is related to a clinical study.
p.000019: • Nonprofit clinical research: research conducted by researchers without the
p.000019: Participation of the pharmaceutical or pharmaceutical industry that meets the following requirements: 1)
p.000019: Sponsor is the academy, a public hospital, a public research institute or entities
p.000019: public; 2) the ownership of the research data belongs to the sponsor from the first moment of the
p.000019: study;
p.000019: 3) there are no agreements between the sponsor and third parties that allow the use of the data for uses that
p.000019: generate an in ustrial property; 4) design, implementation, recruitment, data collection and
p.000019: the dissemination of research results is kept under the control of the sponsor; and, 4) for their
p.000019: characteristic, these studies cannot be part
p.000019: from a development program for an authorization of
p.000019: congenital anomaly or malformation.
p.000019: • Phase I: research in humans where a substance, new drug, is first used
p.000019: or new formulation to provide preliminary information on product safety and establish the
p.000019: tolerability and feasibility thereof. They are usually performed in healthy volunteers or in
p.000019: Some specific cases in patients. They comprise trials of pharmacokinetics and pharmacodynamics.
p.000019: They guide the most appropriate administration schedule for more advanced clinical trials.
p.000019: • Phase II: research in humans where dose / response relationships and the
p.000019: pharmacological effect of new drugs and new therapeutic regimens are identified.
p.000019: Its main objective is to provide preliminary information on the effectiveness of the product and expand the
p.000019: safety data obtained in previous studies. They are performed on patients affected by a certain
p.000019: disease or pathological condition under strict monitoring.
p.000019: • Phase III: research in human beings aimed at assessing the efficacy and safety of
p.000019: experimental treatment, trying to reproduce the usual conditions of use and considering the
p.000019: therapeutic alternatives available in the indication studied. They are controlled and randomized and ideally to
p.000019: triple blind They constitute the gold standard to evaluate new therapeutic alternatives.
...
Social / Soldier
Searching for indicator army:
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p.000019: SPECIAL EDITION
p.000019: Year I - No. 23
p.000019: Quito, Friday June 30, 2017
p.000019: Value: US $ 1.25 + VAT
p.000019: ABG JAQUELINE VARGAS CAMACHO DIRECTOR - SUBROGANTE
p.000019: Quito: Avenida 12 de Octubre N23-99 and Wilson Second Floor
p.000019: Headquarters and sales: Tel. 3941-800
p.000019: Exts .: 2301 - 230
p.000019: Distribution (Warehouse): Mañosca Nº 201 and Av. 10 de Agosto
p.000019: MINISTRY OF PUBLIC HEALTH
p.000019: MINISTERIAL AGREEMENT No. 0075-2017
p.000019: Tel. 243-0 10
p.000019: Guayaquil Branch:
p.000019: Av. 9 de Octubre Nº 1616 and Av. Del Army corner, Building of the Bar Association of Guayas, first floor. Tel.
p.000019: 252-7107
p.000019: Annual Subscription:
p.000019: US $ 400 + VAT for the city of Quito US $ 450 + VAT for the rest of the country
p.000019: Printed in National Editor 32 pages www.registroficial.gob.ec
p.000019: At the service of the country since July 1, 1895
p.000019: EXPAND THE REGULATIONS FOR THE APPROVAL, DEVELOPMENT, SURVEILLANCE AND CONTROL OF CLINICAL TRIALS
p.000019: 2 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: No. 0075-2017
p.000019: THE MINISTER OF PUBLIC HEALTH
p.000019: Considering:
p.000019: That, the Constitution of the Republic of Ecuador mandates: “Art. 57.- Communes are recognized and guaranteed,
p.000019: indigenous communities, peoples and nationalities, in accordance with the Constitution and with the pacts,
p.000019: conventions, declarations and other international human rights instruments, the following rights
p.000019: groups: (…)
p.000019: 12. Maintain, protect and develop collective knowledge; their sciences, technologies and knowledge
p.000019: ancestral; genetic resources that contain biological diversity and agro-bio-diversity;
p.000019: its medicines and traditional medicine practices, including the right to recover, promote
p.000019: and protect ritual and sacred places, as well as plants, animals, minerals and ecosystems within their
p.000019: territories; and knowledge of the resources and properties of fauna and flora. (…) ”;
p.000019: That, the Constitution of the Republic of Ecuador in subparagraph d), numeral 3, of article 66, prohibits
p.000019: the use of genetic material and scientific experimentation that threaten human rights;
...
Social / Women
Searching for indicator women:
(return to top)
p.000019: That the informed consent is legal representative.
p.000019: granted by his
p.000019: voluntarily participate in a clinical trial, who Art. 33.- In clinical studies
p.000019: made in villages
p.000019: must be previously informed about it,
p.000019: and nationality
p.000019: d l Ecuador, in addition to consent
p.000019: which must be recorded in an individual informed consent document, must be
p.000019: make an enquiry
p.000019: informed. These people may be healthy or suffer
p.000019: common taria
p.000019: prior, which should be favorable to the
p.000019: diseases. The research product will be supplied to the research subjects, or the product used
p.000019: as a control, once your informed consent or that of your legal representative has been obtained, in the
p.000019: If applicable.
p.000019: conduct of the study; and obtain additional approval from the community authorities involved in the case.
p.000019: This approval must be recorded in a document duly signed by these authorities, whose copy will be attached to
p.000019: the approval request procedures for the realization of
p.000019: clinical trial No clinical trials may be conducted in
p.000019: Art. 29.- Clinical trials carried out in older adults, people with disabilities, private persons d
p.000019: freedom and those who suffer from catastrophic diseases and high complexity, because they are considered groups
p.000019: of priority or vulnerable attention, should be of specific interest and limited to those whose
p.000019: nature can only be done in this population group.
p.000019: Art. 30.- In women of reproductive age who have agreed to participate in a clinical study, prior to
p.000019: At the beginning of the confirmation will be made that the participant is not pregnant.
p.000019: Access to and use of an effective contraceptive method during development should be ensured
p.000019: of the clinical trial, which will be provided at no cost by the study sponsor, during the entire time of your
p.000019: participation in it, including subjects in male research.
p.000019: Art. 31.- In case of pregnancy during the clinical trial, the woman will be
p.000019: excluded as subject in investigation; In addition, the study sponsor will monitor the
p.000019: patient and newborn until he has reached at least two (2) years of age. The sponsor
p.000019: must compensate
p.000019: people in voluntary isolation (not contacted).
p.000019: In these clinical studies, sponsors and researchers must develop forms and
p.000019: culturally appropriate means with anthropologists, sociologists and translators, to communicate to
p.000019: Participants in the investigation, all the necessary information regarding the trial and fulfill the
p.000019: standard required in the informed consent process. In addition, in the research protocol
p.000019: the procedure they plan to use to communicate the information to should be described and justified
p.000019: the subjects under investigation.
p.000019: CHAPTER IV
p.000019: OF INFORMED CONSENT IN CLINICAL RESEARCH
p.000019: Art. 34.- Informed consent is the communication process that ends in a dated document
...
p.000019: clinical trials, direct and indirect costs generated by l
p.000019: counted from the publication of this Ministerial Agreement in the Official Register, the ARCSA
p.000019: will create the National Registry of Clinical Research Centers, which will be subject to the requirements
p.000019: that this Agency
p.000019: Realization of the essay will be covered in full by the sponsor of the same.
p.000019: It was close to the effect.
p.000019: FOUR.- Within one hundred eighty (180) days,
p.000019: All hospital care that is carried out in a public health facility, in
p.000019: the phases of recruitment, execution, and possible complications that occur during or after
p.000019: Once completed, they will be covered by the sponsor of the essay in accordance with the Tariff of Benefits
p.000019: l National Health System in force.
p.000019: These individuals must be included in the agreement signed between the promoter and the health establishment of the Network
p.000019: Comprehensive Public Health.
p.000019: FIFTH.- The incentives received by researchers working in establishments of the Integral Public Network of
p.000019: Health (RPIS) for its services provided, in the execution of a clinical trial, which are developed in a
p.000019: Establishment of this type, outside their working day, must be recorded in the agreement signed by the promoter and the
p.000019: health establishment of the Comprehensive Public Health Network.
p.000019: In the agreement, additionally the authorization of the health establishment for the researcher
p.000019: you can use the facilities of the establishment for the purposes of the clinical trial, outside your working day
p.000019: labor.
p.000019: SIXTH.- Concerning clinical trials in pregnant women and minors will be subject to
p.000019: a specific regulation based on the content of the
p.000019: counted from the publication of this Ministerial Agreement in the Official Register, the ARCSA
p.000019: will create the National Registry of Clinical Trials, which will be subject to the requirements established by the Agency for
p.000019: The effect.
p.000019: FIFTH.- In the term of one hundred eighty (180) days, counted from the publication of this
p.000019: Ministerial Agreement in the Official Registry, the Ministry of Public Health will create the National Repository of
p.000019: Health Research (RENISA).
p.000019: FINAL DISPOSITION
p.000019: On the execution of this Ministerial Agreement that will come into effect as of its publication in the Registry
p.000019: Official, entrust yourself to the National Agency for Regulation, Control and Health Surveillance ARCSA and the Ministry of Health
p.000019: Public
p.000019: Given in the Metropolitan District of Quito on May 19, 2017.
p.000019: f.) Dr. María Verónica Espinosa Serrano, Minister of Public Health.
p.000019: It is a faithful copy of the document that appears in the file of the National Directorate of the General Secretariat, to which I refer
p.000019: if necessary.- I certify it.- Quito a, May 23, 2017.- f.) Illegible, General Secretariat, Ministry of
p.000019: Public health.
p.000019: Official Registry - Special Edition Nº 23 Friday, June 30, 2017 -
p.000019: 19
p.000019: 20 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: Official Registry - Special Edition Nº 23 Friday, June 30, 2017 -
p.000019: twenty-one
p.000019: 22 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: Official Registry - Special Edition Nº 23 Friday, June 30, 2017 -
p.000019: 2. 3
p.000019: 24 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
...
Social / education
Searching for indicator education:
(return to top)
p.000019: US $ 400 + VAT for the city of Quito US $ 450 + VAT for the rest of the country
p.000019: Printed in National Editor 32 pages www.registroficial.gob.ec
p.000019: At the service of the country since July 1, 1895
p.000019: EXPAND THE REGULATIONS FOR THE APPROVAL, DEVELOPMENT, SURVEILLANCE AND CONTROL OF CLINICAL TRIALS
p.000019: 2 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: No. 0075-2017
p.000019: THE MINISTER OF PUBLIC HEALTH
p.000019: Considering:
p.000019: That, the Constitution of the Republic of Ecuador mandates: “Art. 57.- Communes are recognized and guaranteed,
p.000019: indigenous communities, peoples and nationalities, in accordance with the Constitution and with the pacts,
p.000019: conventions, declarations and other international human rights instruments, the following rights
p.000019: groups: (…)
p.000019: 12. Maintain, protect and develop collective knowledge; their sciences, technologies and knowledge
p.000019: ancestral; genetic resources that contain biological diversity and agro-bio-diversity;
p.000019: its medicines and traditional medicine practices, including the right to recover, promote
p.000019: and protect ritual and sacred places, as well as plants, animals, minerals and ecosystems within their
p.000019: territories; and knowledge of the resources and properties of fauna and flora. (…) ”;
p.000019: That, the Constitution of the Republic of Ecuador in subparagraph d), numeral 3, of article 66, prohibits
p.000019: the use of genetic material and scientific experimentation that threaten human rights;
p.000019: That, article 350 of the Constitution of the Republic of Ecuador states that the Higher Education System
p.000019: Its purpose is academic and professional training with a scientific and humanistic vision; the investigation
p.000019: scientific and technological; innovation, promotion, development and dissemination of knowledge and
p.000019: cultures; the construction of solutions for the country's problems, in relation to the objectives of the
p.000019: development;
p.000019: rectory functions in health; as well as the responsibility for the application, control and monitoring of compliance with
p.000019: this law; and, the norms that it dictates for its full validity will be obligatory. ”;
p.000019: That, the aforementioned Organic Health Law, in its article 6, orders:
p.000019: “It is the responsibility of the Ministry of Public Health: (…)
p.000019: 32. Participate, in coordination with the competent national body, in the research and development of science
p.000019: and health technology, safeguarding the validity of human rights, under bioethical principles; (…). ”;
p.000019: That, every person, without discrimination for any reason, has in relation to health the right not to be subject to
p.000019: tests, clinical, laboratory or research trials, without your prior written knowledge and consent,
p.000019: nor be subjected to diagnostic tests or exams, except when expressly determined by law or in case
p.000019: of emergency or urgency in which your life is in danger, as determined by article 7, literal l) of the Law
p.000019: Organic Health;
p.000019: That, the Organic Health Law, in article 207, prescribes that scientific research in health as well as
p.000019: the use and development of biotechnology, will be oriented to priorities and needs na
...
p.000019: r) The batch certification of the investigational drug, with stability and expiration date.
p.000019: s) The general budget of the trial, according to the model that
p.000019: availability of the health establishment for the
p.000019: It appears in Annex 3 of this
p.000019: Regulation.
p.000019: clinical trial, issued by the maximum
p.000019: authority of the establishments that are proposed
p.000019: t) Co ia del
p.000019: contract concluded between the researcher
p.000019: as clinical research centers.
p.000019: i) The commitment letter signed by the researcher
p.000019: Principals and the promoter.
p.000019: u) In cases where clinical research centers
p.000019: principal of
p.000019: each center
p.000019: clinical research
p.000019: are located in health facilities of
p.000019: participant in the clinical trial, in which it is indicated that he will participate as a researcher in the study, which has
p.000019: been trained on the research protocol and therefore knows it and is in compliance with it, the
p.000019: monetary value that you will receive for your services, as well as the determination of your responsibilities in the study.
p.000019: j) The list of the clinical research center or centers, which includes the details of all researchers and their
p.000019: work team by center, who would participate in the trial in the country, specifying the type of
p.000019: health establishment, professional titles of each member and their role in the study.
p.000019: k) Enrollment of the principal investigators of the study, in the database of the Ministry of
p.000019: Public Health by the National Directorate of Health Intelligence, or who exercises their powers, as long as
p.000019: the National Secretariat of Higher Education, Science, Technology and Research - SENESCYT develop this
p.000019: tool and coordinate with the Ministry of Public Health the existence of a unique database of
p.000019: researchers.
p.000019: l) The resume of the principal investigator and his collaborators for each research center
p.000019: clinic
p.000019: the Comprehensive Public Health Network, a copy of the agreement between the health establishment and the
p.000019: promoter.
p.000019: v) The list of supplies necessary for the development of the clinical trial.
p.000019: w) The data collection notebook.
p.000019: x) The flowchart of handling adverse events and adverse reactions.
p.000019: and) The notification form of suspicion of unexpected serious adverse reactions and / or serious adverse event of the
p.000019: clinical trial
p.000019: z) The sponsor's sworn commitment to deliver the final report of the essay to the ARCSA.
p.000019: aa) Copy of the civil liability insurance policy issued by an established insurance company
p.000019: in Ecuador, empowered for this purpose. The policy will cover the responsibilities of all those involved in the
p.000019: research, as well as those of the clinical research center where the clinical trial is conducted. The
p.000019: coverage should cover the execution of the clinical trial
p.000019: Official Registry - Special Edition Nº 23
p.000019: and it will be extended at least one (1) year after its completion, in order to cover the consequences that are demonstrated to be
p.000019: derived from the clinical trial in question. After passing an essay, if it lasts more than one (1) year, the
p.000019: promoter will present to the ARCSA a commitment to renew the policy, at least three (3) months of
p.000019: anticipation of its expiration; and present the renewed policy once it is issued.
p.000019: The civil liability policy must be subject to the provisions of the Monetary Organic Code and
...
p.000019: following:
p.000019: a) Select and evaluate research centers in clinical trials and researchers, to
p.000019: Develop the clinical trial.
p.000019: b) Ensure, through monitoring visits, that clinical trials are carried out according to
p.000019: ethical standards and methodology established in Good Clinical Practices, ensuring compliance with the
p.000019: Authenticated protocol.
p.000019: they must develop actions in the field of health and
p.000019: c) An liza
p.000019: the data obtained during the process of
p.000019: have technical personnel trained in Good Clinical Practices or with experience to carry out the functions
p.000019: to be legally delegated by the sponsor for the development of clinical trials.
p.000019: research, generating partial and final results of the project.
p.000019: d) Forward to ARCSA and the Research Ethics Committee in Human Beings the updates
p.000019: of the
p.000019: Art. 80.-
p.000019: The
p.000019: Research Organizations by
p.000019: Researcher's Manual, immediately produced
p.000019: Contract, to start and develop their activities, must be registered in the National Registry of
p.000019: Contract Research Organizations in charge of ARCSA and for this purpose they will present:
p.000019: a) Registration request addressed to the ARCSA.
p.000019: b) Copy of the constitution document of the Contract Research Organization.
p.000019: c) Structural organization chart.
p.000019: d) Standard operating procedures.
p.000019: e) List of personnel and specific functions assigned to each one.
p.000019: f) Updated resumes of the organization's officers.
p.000019: Art. 81.- Contract Research Organizations must have researchers duly registered in the
p.000019: database of the Ministry of Public Health, until the Ministry of Higher Education, Science, Technology and
p.000019: Research - SENESCYT develop the tool for such registration.
p.000019: these updates.
p.000019: CHAPTER XII OF THE MONITOR
p.000019: Art. 85.- Monitor is the health professional with experience in biomedical or clinical research,
p.000019: designated by the sponsor or by the Contract Research Organization to follow up
p.000019: direct from the execution of the trial, who acts as a link between the sponsor and the researcher
p.000019: principal. Monitors must have an academic degree related to health and / or biomedical sciences, accredit
p.000019: experience to monitor a clinical trial and have training certificates in Good Clinical Practices and
p.000019: in Ethics of Clinical Research.
p.000019: Art. 86.- The responsibilities of the monitor in relation to clinical trials are the following:
p.000019: a) Verify that the clinical trial being carried out is authorized by the ARCSA.
p.000019: b) Verify the protection, exercise of the rights and well-being of the subjects under investigation.
p.000019: 14 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: c) Verify that the research team is correctly informed and trained
p.000019: on the content of the protocol and the responsibility of the researchers in the clinical trial.
p.000019: d) Verify that the research team and the health establishment where the trial is carried out
p.000019: clinical, meet the requirements for the development of the research, as well as the functions
p.000019: specific assigned to each one.
p.000019: e) Verify the process and availability of informed consents of all
p.000019: subjects involved in the clinical trial, before inclusion in the study.
p.000019: f) Verify, according to the Good Cynical Practices, the update of the documents for the
...
p.000019: products under investigation in clinical research centers.
p.000019: o) Verify if the correct instructions on research subjects have been provided
p.000019: the use, handling, storage and return of the products under investigation.
p.000019: p) Inform the investigator in writing of errors and deviations from the application of the protocol, in case of
p.000019: have them, as well as the measures that must be implemented to prevent them from recurring.
p.000019: product research soul according to its characteristics; appropriate conditions for
p.000019: consultation and training; guarantee of immediate attention before a potential emergency-medical emergency. From
p.000019: there is no capacity to attend emergencies / emergencies in the clinical research center itself, its
p.000019: benefit must be duly guaranteed by means of a contract or agreement with another health facility, without
p.000019: restriction of any type of attention for the study subjects.
p.000019: CHAPTER XIV
p.000019: FROM THE MAIN RESEARCHER
p.000019: Art. 90.- The principal investigator is the professional responsible for conducting the test.
p.000019: clinician in a clinical research center and who leads the research team. According to
p.000019: complexity of the study determined by the ARCSA, the principal investigator must be a health professional
p.000019: with a fourth level degree, related to the area to investigate. These titles must be registered in the
p.000019: National Secretary of Higher Education, Science, Technology and Innovation (SENESCYT) and before the Ministry of
p.000019: Public health.
p.000019: The principal investigator must prove that they have participated in at least one previous clinical trial and
p.000019: have certificates with academic endorsement of training in Good Clinical Practices and Ethics of the
p.000019: Investigation.
p.000019: Official Registry - Special Edition Nº 23
p.000019: Art. 91.- The responsibilities of the principal investigator in the clinical trial are:
p.000019: a) Know in detail the research protocol and all available information about the product
p.000019: in research.
p.000019: b) Know and comply with Good Clinical Practices and applicable national health regulations.
p.000019: c) Obtain, prior to the start of the clinical trial, the letter of declaration of institutional interest of
p.000019: execution of the study, signed by the legal representative of the health establishment in which
p.000019: will develop the same.
p.000019: d) Obtain the informed consent of the subjects participating in the study.
p.000019: e) Obtain the approval of the protocol, of the informed consent, of the Manual of
p.000019: Researcher and other documents described in Good Clinical Practices, by a
p.000019: Research Ethics Committee on Human Beings approved by the Ministry of Public Health, prior to
p.000019: Start of clinical trial.
p.000019: f) Select the personnel involved in the clinical trial and verify that it is properly
p.000019: informed and trained regarding the study.
p.000019: g) Clearly establish the procedures to follow
p.000019: Friday, June 30, 2017 - 15
...
Social / gender
Searching for indicator gender:
(return to top)
p.000019: scientific and technological; innovation, promotion, development and dissemination of knowledge and
p.000019: cultures; the construction of solutions for the country's problems, in relation to the objectives of the
p.000019: development;
p.000019: rectory functions in health; as well as the responsibility for the application, control and monitoring of compliance with
p.000019: this law; and, the norms that it dictates for its full validity will be obligatory. ”;
p.000019: That, the aforementioned Organic Health Law, in its article 6, orders:
p.000019: “It is the responsibility of the Ministry of Public Health: (…)
p.000019: 32. Participate, in coordination with the competent national body, in the research and development of science
p.000019: and health technology, safeguarding the validity of human rights, under bioethical principles; (…). ”;
p.000019: That, every person, without discrimination for any reason, has in relation to health the right not to be subject to
p.000019: tests, clinical, laboratory or research trials, without your prior written knowledge and consent,
p.000019: nor be subjected to diagnostic tests or exams, except when expressly determined by law or in case
p.000019: of emergency or urgency in which your life is in danger, as determined by article 7, literal l) of the Law
p.000019: Organic Health;
p.000019: That, the Organic Health Law, in article 207, prescribes that scientific research in health as well as
p.000019: the use and development of biotechnology, will be oriented to priorities and needs na
p.000019: Regional, subject to bioethical principles, with multi-cultural, rights and gender foundations, incorporated
p.000019: l s traditional and alternative medicines;
p.000019: Q e, as established in article 208 of the Ibid Law, scientific scientific research in
p.000019: health will be regulated and controlled by the National Health Authority, in coordination with the agencies
p.000019: competent, subject to bioethical rights and rights, prior
p.000019: That, the aforementioned Constitution of the Republic of the United States provides, in article 361, that the State shall exercise the
p.000019: Rectory of the National Health System through the National Health Authority, which will be responsible
p.000019: to formulate the national health policy, and to regulate, regulate and control all activities related to
p.000019: health, as well as the functioning of the entities of the sector;
p.000019: That, the Constitution of the Republic of Ecuador, in its article 387, numeral 2, indicates that it is
p.000019: State responsibility to promote the generation and production of knowledge, promote
p.000019: scientific and technological research, and enhance ancestral knowledge, in order to contribute to the
p.000019: realization of good living, to sumak kawsay;
p.000019: That, the Universal Declaration on Bioethics and Human Rights approved by the General Conference of the
p.000019: UNESCO in 2005, in its article 19, urges countries to create, promote and support committees of
p.000019: independent, multidisciplinary and pluralistic ethics with a view to assessing ethical, legal,
p.000019: relevant scientific and social, raised by research projects relating to human beings;
p.000019: to provide advice on ethical problems in clinical contexts; and to evaluate the progress of the
p.000019: science and technology;
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.000019: Access to and use of an effective contraceptive method during development should be ensured
p.000019: of the clinical trial, which will be provided at no cost by the study sponsor, during the entire time of your
p.000019: participation in it, including subjects in male research.
p.000019: Art. 31.- In case of pregnancy during the clinical trial, the woman will be
p.000019: excluded as subject in investigation; In addition, the study sponsor will monitor the
p.000019: patient and newborn until he has reached at least two (2) years of age. The sponsor
p.000019: must compensate
p.000019: people in voluntary isolation (not contacted).
p.000019: In these clinical studies, sponsors and researchers must develop forms and
p.000019: culturally appropriate means with anthropologists, sociologists and translators, to communicate to
p.000019: Participants in the investigation, all the necessary information regarding the trial and fulfill the
p.000019: standard required in the informed consent process. In addition, in the research protocol
p.000019: the procedure they plan to use to communicate the information to should be described and justified
p.000019: the subjects under investigation.
p.000019: CHAPTER IV
p.000019: OF INFORMED CONSENT IN CLINICAL RESEARCH
p.000019: Art. 34.- Informed consent is the communication process that ends in a dated document
p.000019: and signed by the principal investigator and the participant of a clinical study or its legal representative,
p.000019: when appropriate, who should be able to express their opinion freely and without coercion. The
p.000019: Participant or his legal representative, through informed consent, will express their willingness to be part of the
p.000019: I study with full
p.000019: 8 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: knowledge of its purpose, the procedures, benefits and risks to which it will be submitted, the
p.000019: possible treatment alternatives and the grounds for exclusion from the investigation, being able to revoke
p.000019: Your consent at any time.
p.000019: The withdrawal of the informed consent of the participant will be accepted at any time, ensuring that
p.000019: their disengagement from the study does not affect or endanger the health of the subject under investigation.
p.000019: If a conflict of opinion arises between the subject under investigation and his legal representative, regarding his
p.000019: Participation in the clinical trial, at any time during or before the study, will exclude
p.000019: subject provided that such exclusion does not jeopardize your health.
p.000019: In any case of exclusion of a participant from a clinical trial, the investigator and the
p.000019: Sponsor will guarantee the monitoring of the subject for at least two (2) years.
p.000019: Art. 35.- The principal investigator or a delegate thereof who is part of the research team,
p.000019: inform in writing and verbally the subject under investigation or his legal representative, when
p.000019: appropriate, regarding the risks, discomforts and possible benefits of the study in which it is raised
p.000019: your participation, using simple, clear and warm terms.
p.000019: Art. 36.- In the case of illiterate persons, their fingerprint will be registered in the document of
p.000019: consent
p.000019: d) Selection criteria, exclusion and number of subjects under investigation.
p.000019: e) Duration, side effects, direct benefits of participation in the clinical trial, the expected risks
p.000019: for the subject, including possible adverse reactions, risks to the health and well-being of the couple or
p.000019: spouse. Possible benefits for the community or society.
p.000019: f) Alternative treatments that could be beneficial for the subject under investigation.
p.000019: g) Point out that the participation of the subject in the clinical trial is voluntary and that their decision to participate
p.000019: or not the study will not influence in any way the health care process that the subject requires in
p.000019: investigation.
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000019: the National Agency for Regulation, Control and Health Surveillance - ARCSA, an instance to exercise
p.000019: This attribution must strictly comply with the provisions of the Constitution of the Republic, regulations
p.000019: international, the Organic Law of Health and other norms related to the subject.
p.000019: The ARCSA will also be guided by the guidelines of the Helsinki Declaration of the
p.000019: World Medical Association; of the Pan American Network for the Harmonization of Pharmaceutical Regulation (Network
p.000019: PARF); International Ethical Guidelines for Biomedical Research
p.000019: the Regulations for the approval and monitoring of
p.000019: in Human Beings of the Council of
p.000019: Organizations
p.000019: Research Ethics Committees in Human Beings
p.000019: Science Internationals
p.000019: Medical (CIOMS); Y,
p.000019: (CEISH) and of the Ethical Committees of Assistance for
p.000019: Good Clinical Practices
p.000019: (both of the Conference
p.000019: Health (CEAS); and, International of
p.000019: Harmonization like those of the Parf Network),
p.000019: as well as the succinct declarations and revisions that
p.000019: That, there are universal regulatory bodies related to the generation of safety conditions,
p.000019: well-being, respect and dignity of human beings in the
p.000019: update the referred documents; or others of which is equal to the Ecuadorian State
p.000019: conducting scientific research, which is why it is necessary for Ecuador to have an instrument
p.000019: Art. 4.- The conditions qu
p.000019: clinical trials will be conducted under ensure respect for dignity
p.000019: which based on ethical and scientific fundamentals
p.000019: all
p.000019: human
p.000019: human rights, autonomy, consent
p.000019: activities related to clinical trials in humans.
p.000019: info mado, precautionary principle, personal integrity, privacy, confidentiality, equality, justice,
p.000019: equity, non-discrimination, cultural diversity and welfare of
p.000019: IN EXCERCISE
p.000019: OF THE ATTRIBU
p.000019: IONS
p.000019: persons.
p.000019: CONFERED PO
p.000019: THE ARTICLES
p.000019: 151 Y
p.000019: 154, NUMBER 1,
p.000019: OF THE CONSTITUTION
p.000019: Art. 5.- In clinical trials, rights, security
p.000019: OF THE REPUBLIC AND BY ARTICLE 17 and welfare of persons and of society,
p.000019: prevail
p.000019: OF THE STATUTE
p.000019: OF THE LEGAL REGIME AND
p.000019: on scientific and economic interests. Will be evaluated
p.000019: ADMINISTRATIVE OF THE EXECUTIVE FUNCTION
p.000019: Agree:
p.000019: ISSUE THE REGULATIONS FOR THE APPROVAL, DEVELOPMENT, SURVEILLANCE AND CONTROL OF CLINICAL TRIALS
p.000019: CHAPTER I
p.000019: PURPOSE AND SCOPE
p.000019: Art. 1.- Purpose.- The purpose of this Regulation is to regulate the approval, execution, monitoring,
p.000019: surveillance and control of clinical trials in Ecuador, which are carried out with medications,
p.000019: biological products and processed natural products for medicinal use.
p.000019: For the purposes of this Regulation, the terms "trial" and "study" shall be used interchangeably.
p.000019: mainly the therapeutic benefits and the risks and inconveniences for the test subject and
p.000019: for public health.
p.000019: Art. 6.- For the realization of a clinical trial in Ecuador it is required that every natural person or
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General/Other / Public Emergency
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p.000019: territories; and knowledge of the resources and properties of fauna and flora. (…) ”;
p.000019: That, the Constitution of the Republic of Ecuador in subparagraph d), numeral 3, of article 66, prohibits
p.000019: the use of genetic material and scientific experimentation that threaten human rights;
p.000019: That, article 350 of the Constitution of the Republic of Ecuador states that the Higher Education System
p.000019: Its purpose is academic and professional training with a scientific and humanistic vision; the investigation
p.000019: scientific and technological; innovation, promotion, development and dissemination of knowledge and
p.000019: cultures; the construction of solutions for the country's problems, in relation to the objectives of the
p.000019: development;
p.000019: rectory functions in health; as well as the responsibility for the application, control and monitoring of compliance with
p.000019: this law; and, the norms that it dictates for its full validity will be obligatory. ”;
p.000019: That, the aforementioned Organic Health Law, in its article 6, orders:
p.000019: “It is the responsibility of the Ministry of Public Health: (…)
p.000019: 32. Participate, in coordination with the competent national body, in the research and development of science
p.000019: and health technology, safeguarding the validity of human rights, under bioethical principles; (…). ”;
p.000019: That, every person, without discrimination for any reason, has in relation to health the right not to be subject to
p.000019: tests, clinical, laboratory or research trials, without your prior written knowledge and consent,
p.000019: nor be subjected to diagnostic tests or exams, except when expressly determined by law or in case
p.000019: of emergency or urgency in which your life is in danger, as determined by article 7, literal l) of the Law
p.000019: Organic Health;
p.000019: That, the Organic Health Law, in article 207, prescribes that scientific research in health as well as
p.000019: the use and development of biotechnology, will be oriented to priorities and needs na
p.000019: Regional, subject to bioethical principles, with multi-cultural, rights and gender foundations, incorporated
p.000019: l s traditional and alternative medicines;
p.000019: Q e, as established in article 208 of the Ibid Law, scientific scientific research in
p.000019: health will be regulated and controlled by the National Health Authority, in coordination with the agencies
p.000019: competent, subject to bioethical rights and rights, prior
p.000019: That, the aforementioned Constitution of the Republic of the United States provides, in article 361, that the State shall exercise the
p.000019: Rectory of the National Health System through the National Health Authority, which will be responsible
p.000019: to formulate the national health policy, and to regulate, regulate and control all activities related to
p.000019: health, as well as the functioning of the entities of the sector;
p.000019: That, the Constitution of the Republic of Ecuador, in its article 387, numeral 2, indicates that it is
p.000019: State responsibility to promote the generation and production of knowledge, promote
p.000019: scientific and technological research, and enhance ancestral knowledge, in order to contribute to the
p.000019: realization of good living, to sumak kawsay;
p.000019: That, the Universal Declaration on Bioethics and Human Rights approved by the General Conference of the
...
p.000019: protocol and its approved modifications
p.000019: in ca o of
p.000019: clinical research count on qualified researchers,
p.000019: have them, as well as the requirements
p.000019: inados by
p.000019: equipment and
p.000019: appropriate means for development
p.000019: the Research Ethics Committee in Hu Beings
p.000019: years
p.000019: del est gave, among them, suitable conditions for
p.000019: by the National Health Authority and Good Clinical Practices
p.000019: k) Review the investigator's file making sure it is complete and up to date and identify errors in
p.000019: case of presenting
p.000019: l) Verify that the backups of all types of resources are recorded in the investigator's file
p.000019: adverse events and reactions, during the development of the clinical trial.
p.000019: m) Review the handling of the product under investigation, its provision and storage conditions, in order to
p.000019: verify if the established in the investigation protocol is fulfilled.
p.000019: n) Verify the existence and application of the procedure for receiving, using and returning the
p.000019: products under investigation in clinical research centers.
p.000019: o) Verify if the correct instructions on research subjects have been provided
p.000019: the use, handling, storage and return of the products under investigation.
p.000019: p) Inform the investigator in writing of errors and deviations from the application of the protocol, in case of
p.000019: have them, as well as the measures that must be implemented to prevent them from recurring.
p.000019: product research soul according to its characteristics; appropriate conditions for
p.000019: consultation and training; guarantee of immediate attention before a potential emergency-medical emergency. From
p.000019: there is no capacity to attend emergencies / emergencies in the clinical research center itself, its
p.000019: benefit must be duly guaranteed by means of a contract or agreement with another health facility, without
p.000019: restriction of any type of attention for the study subjects.
p.000019: CHAPTER XIV
p.000019: FROM THE MAIN RESEARCHER
p.000019: Art. 90.- The principal investigator is the professional responsible for conducting the test.
p.000019: clinician in a clinical research center and who leads the research team. According to
p.000019: complexity of the study determined by the ARCSA, the principal investigator must be a health professional
p.000019: with a fourth level degree, related to the area to investigate. These titles must be registered in the
p.000019: National Secretary of Higher Education, Science, Technology and Innovation (SENESCYT) and before the Ministry of
p.000019: Public health.
p.000019: The principal investigator must prove that they have participated in at least one previous clinical trial and
p.000019: have certificates with academic endorsement of training in Good Clinical Practices and Ethics of the
p.000019: Investigation.
p.000019: Official Registry - Special Edition Nº 23
p.000019: Art. 91.- The responsibilities of the principal investigator in the clinical trial are:
p.000019: a) Know in detail the research protocol and all available information about the product
p.000019: in research.
p.000019: b) Know and comply with Good Clinical Practices and applicable national health regulations.
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p.000019: rectory functions in health; as well as the responsibility for the application, control and monitoring of compliance with
p.000019: this law; and, the norms that it dictates for its full validity will be obligatory. ”;
p.000019: That, the aforementioned Organic Health Law, in its article 6, orders:
p.000019: “It is the responsibility of the Ministry of Public Health: (…)
p.000019: 32. Participate, in coordination with the competent national body, in the research and development of science
p.000019: and health technology, safeguarding the validity of human rights, under bioethical principles; (…). ”;
p.000019: That, every person, without discrimination for any reason, has in relation to health the right not to be subject to
p.000019: tests, clinical, laboratory or research trials, without your prior written knowledge and consent,
p.000019: nor be subjected to diagnostic tests or exams, except when expressly determined by law or in case
p.000019: of emergency or urgency in which your life is in danger, as determined by article 7, literal l) of the Law
p.000019: Organic Health;
p.000019: That, the Organic Health Law, in article 207, prescribes that scientific research in health as well as
p.000019: the use and development of biotechnology, will be oriented to priorities and needs na
p.000019: Regional, subject to bioethical principles, with multi-cultural, rights and gender foundations, incorporated
p.000019: l s traditional and alternative medicines;
p.000019: Q e, as established in article 208 of the Ibid Law, scientific scientific research in
p.000019: health will be regulated and controlled by the National Health Authority, in coordination with the agencies
p.000019: competent, subject to bioethical rights and rights, prior
p.000019: That, the aforementioned Constitution of the Republic of the United States provides, in article 361, that the State shall exercise the
p.000019: Rectory of the National Health System through the National Health Authority, which will be responsible
p.000019: to formulate the national health policy, and to regulate, regulate and control all activities related to
p.000019: health, as well as the functioning of the entities of the sector;
p.000019: That, the Constitution of the Republic of Ecuador, in its article 387, numeral 2, indicates that it is
p.000019: State responsibility to promote the generation and production of knowledge, promote
p.000019: scientific and technological research, and enhance ancestral knowledge, in order to contribute to the
p.000019: realization of good living, to sumak kawsay;
p.000019: That, the Universal Declaration on Bioethics and Human Rights approved by the General Conference of the
p.000019: UNESCO in 2005, in its article 19, urges countries to create, promote and support committees of
p.000019: independent, multidisciplinary and pluralistic ethics with a view to assessing ethical, legal,
p.000019: relevant scientific and social, raised by research projects relating to human beings;
p.000019: to provide advice on ethical problems in clinical contexts; and to evaluate the progress of the
p.000019: science and technology;
p.000019: That, the Organic Health Law provides: “Art. 4. The national health authority is the Ministry of
p.000019: Public Health, entity to which the exercise of the
p.000019: informed and in writing, respecting confidentiality;
p.000019: That, the Code of Children and Adolescents, in the article
p.000019: 20 prescribes: “Right to life.- Children and adolescents have the right to life from their
p.000019: conception. It is the obligation of the State, society and the family to ensure, by all means at their disposal, their
p.000019: Survival and development Medical and genetic experiments and manipulations are prohibited from fertilization of
p.000019: ovum until the birth of children and adolescents; and the use of any technique or practice that
p.000019: endanger your life or affect your integrity or integral development. ”;
p.000019: That, the Helsinki Declaration of the World Medical Association - Ethical Principles for
p.000019: Medical Research in Human Beings, in its article 8, indicates that in medical research in beings
p.000019: human, the rights of the person participating in the investigation must always have the primacy over all
p.000019: other interests; and that for such research a prior evaluation and approval by a
p.000019: independent ethics committee;
p.000019: That, the International Ethical Guidelines for Biomedical Research in Human Beings, prepared by the Council of
p.000019: International Medical Sciences Organizations (CIOMS), in collaboration with the World Organization of
p.000019: Health, establishes among its articles that all proposals for research in humans
p.000019: Official Registry - Special Edition Nº 23
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p.000019: g) The pharmacological report on the marketing approval of the product under investigation
p.000019: issued by the ARCSA, if it were the case of post-marketing studies.
p.000019: h) The letters of declaration of institutional interest and
p.000019: to show experience in the specialty being studied; and, development training of
p.000019: clinical trials, Good Clinical Practices and related subjects.
p.000019: m) The schedule of the study to be carried out in the country.
p.000019: n) A certificate of the quality management system of the clinical laboratory or of the institution in the
p.000019: that is the clinical laboratory that will participate in the study.
p.000019: o) The detail of the product under investigation and other medicines to be used in the test,
p.000019: according to the model in Annex 2 of these Regulations, as well as the label of the product under investigation
p.000019: and packing.
p.000019: p) Health risk assessment reports in the previous phases of the studies (Phase I, II and III), for
p.000019: that the ARCSA establish the risk-benefit balance of the product under investigation.
p.000019: q) Certification of Good Manufacturing Practices of the drug manufacturing plant
p.000019: in research.
p.000019: r) The batch certification of the investigational drug, with stability and expiration date.
p.000019: s) The general budget of the trial, according to the model that
p.000019: availability of the health establishment for the
p.000019: It appears in Annex 3 of this
p.000019: Regulation.
p.000019: clinical trial, issued by the maximum
p.000019: authority of the establishments that are proposed
p.000019: t) Co ia del
p.000019: contract concluded between the researcher
p.000019: as clinical research centers.
p.000019: i) The commitment letter signed by the researcher
p.000019: Principals and the promoter.
p.000019: u) In cases where clinical research centers
p.000019: principal of
p.000019: each center
p.000019: clinical research
p.000019: are located in health facilities of
p.000019: participant in the clinical trial, in which it is indicated that he will participate as a researcher in the study, which has
p.000019: been trained on the research protocol and therefore knows it and is in compliance with it, the
p.000019: monetary value that you will receive for your services, as well as the determination of your responsibilities in the study.
p.000019: j) The list of the clinical research center or centers, which includes the details of all researchers and their
p.000019: work team by center, who would participate in the trial in the country, specifying the type of
p.000019: health establishment, professional titles of each member and their role in the study.
p.000019: k) Enrollment of the principal investigators of the study, in the database of the Ministry of
p.000019: Public Health by the National Directorate of Health Intelligence, or who exercises their powers, as long as
p.000019: the National Secretariat of Higher Education, Science, Technology and Research - SENESCYT develop this
p.000019: tool and coordinate with the Ministry of Public Health the existence of a unique database of
p.000019: researchers.
p.000019: l) The resume of the principal investigator and his collaborators for each research center
p.000019: clinic
p.000019: the Comprehensive Public Health Network, a copy of the agreement between the health establishment and the
p.000019: promoter.
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p.000019: necessary.
p.000019: d) Establish deadlines for compliance with the plans to solve the nonconformities detected by the
p.000019: ARCSA during the inspections you perform.
p.000019: e) Temporarily or definitively suspend the start / execution of a clinical trial, according to
p.000019: corresponding, due to the lack of guarantees for the security of the subject under investigation.
p.000019: f) Revoke the approval of a clinical trial at any stage, if there is no security for
p.000019: Research participants
p.000019: g) Others deemed necessary.
p.000019: Art. 26.- The ARCSA will suspend or cancel a clinical trial that is being carried out in the country and will revoke the
p.000019: approval granted, depending on the severity of the case, for the following causes:
p.000019: a) Prevent by any person related to the clinical trial, the actions of the inspectors of the
p.000019: ARCSA
p.000019: b) Use a product under investigation in humans for approval of the clinical trial protocol
p.000019: by the ARCSA.
p.000019: c) R alizar the clinical trial without adjusting to the content of the protocols on the basis of which
p.000019: granted approval or modifications to the research protocol authorized for the trial
p.000019: clinical or make amendments to it, without prior authorization from the ARCSA.
p.000019: d) Failure to comply with the obligation to timely inform the ARCSA and the Research Ethics Committee in Beings
p.000019: Corresponding human, serious adverse events and unexpected serious adverse reactions of the product in
p.000019: investigation.
p.000019: e) Disseminate information to identify the subject under investigation, except when said information has been
p.000019: requested by the National Health Authority or by judicial means to investigate a human rights violation.
p.000019: f) Carry out promotion or advertising of the product in the investigation phase.
p.000019: g) Breach of the BPC, which puts the security of the subject under investigation at risk.
p.000019: h) Perform the clinical trial without the informed consent of the subject in
p.000019: investigation or, where appropriate, of the person empowered to grant it.
p.000019: Official Registry - Special Edition Nº 23
p.000019: i) Sign the informed consent with the participants in the investigation, after
p.000019: Started the execution of the clinical trial.
p.000019: j) Adulterate or falsify the information required in this Regulation or related data
p.000019: With the essay.
p.000019: k) Not guarantee the protection, benefits, rights and security of the subjects participating in the
p.000019: clinical research.
p.000019: l) Failure to comply with the provisions established in this Regulation.
p.000019: Art. 27.- In the event that the ARCSA detects and verifies the conduct and conduct of a clinical trial without
p.000019: the corresponding approval will provide both the cancellation of the study and the execution of measures that protect
p.000019: the subjects under investigation, in addition to applying the sanctions to which it may take place.
p.000019: CHAPTER III
p.000019: Friday, June 30, 2017 - 7
p.000019: both the mother and the newborn of presenting subsequent damages produced during pregnancy or
p.000019: would have caused the newborn due to the execution of the investigation.
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p.000019: that the subject who consents to it, exempts the sponsor, researcher or his or her responsibility
p.000019: representatives before any responsibility for negligence, or for risks derived from the clinical trial.
p.000019: Art. 39.- The informed consent document for clinical research must contain the following (Annex 4):
p.000019: a) Clear information that the participant will be part of a study that may or may not have
p.000019: positive results.
p.000019: b) The justification and objective of the clinical trial.
p.000019: c) All procedures to be performed, clearly specifying the aspects that
p.000019: Be experimental and your purpose.
p.000019: revoke your mind at any time and stop participating in the study, for which the researcher
p.000019: it must ensure the proper process for the exclusion of the participant while preserving their safety, and without affecting their
p.000019: access to the medical care you require.
p.000019: m) The measures to be taken to guarantee the privacy and confidentiality of the
p.000019: information of the subjects under investigation.
p.000019: n) If biological samples are required as part of the research protocol, it must be specified
p.000019: that they will serve exclusively for the essay for which the subject gives his consent.
p.000019: Additional express consent will be required, in the case of consulting the participant about their consent
p.000019: for the future use of these samples, for other investigations defined as priorities for the Authority
p.000019: National Health. This last document should indicate how long the samples will be stored, where and
p.000019: under what custodian This new investigation must comply with all the requirements to carry out a
p.000019: health research, and obtain the approval of a CEISH and the National Health Authority prior to its
p.000019: execution.
p.000019: o) The obligation of the investigator to inform the subject under investigation in due course and timely
p.000019: the product under investigation, although the information could affect your decision to continue participating in the
p.000019: clinical trial
p.000019: Official Registry - Special Edition Nº 23
p.000019: p) The free delivery of the product under investigation, the time during which the
p.000019: same, the complementary exams that are required for research purposes and the
p.000019: standardized procedure, which according to the study protocol, research subjects should receive.
p.000019: q) The participant's right to obtain additional information, through the researcher, on
p.000019: any aspect of the study, if required.
p.000019: r) The availability of medical treatment and the compensation legally entitled to
p.000019: subject under investigation, according to the insurance policy of the study contracted by the promoter, to cover possible damages
p.000019: caused directly or indirectly by the product under investigation.
p.000019: s) The contact information of the principal investigator and the clinical research center to which the
p.000019: subject under investigation, if there were any health effects related to the clinical study.
p.000019: t) The obligation of the investigator to inform, in verbal and written form, the subjects in
p.000019: investigation or its legal representative, when applicable, any new information or changes
p.000019: in the study protocol that could affect the participant's safety or his decision to continue in
p.000019: the study. In these cases the need to obtain a new consent will be evaluated.
p.000019: u) The obligation to communicate the results of the investigation to the subjects under investigation.
...
p.000019: use. The ARCSA must authorize the use of any investigational medication under exceptional conditions.
p.000019: CHAPTER VIII
p.000019: OF THE REGISTRATION AND PUBLICATION BASE OF CLINICAL TRIALS
p.000019: Art. 59.- The ARCSA will create and maintain the National Registry of Clinical Trials, observing the requirements of the
p.000019: Primary Registry of the World Health Organization. This record will be a publicly accessible database. The
p.000019: Agency will provide access to this registry and additional information that the Ministry of Public Health requires
p.000019: for the purpose of monitoring and control of the investigation.
p.000019: Art. 60.- In the case of publication of results of a clinical trial developed in Ecuador in
p.000019: national or international scientific journals, the researcher will send a mandatory
p.000019: copy of said publication to the ARCSA and the Ministry of Public Health. Such publications in any case
p.000019: will contain identification data of the study subjects.
p.000019: Friday, June 30, 2017 - 11
p.000019: Art. 63.- CEISH members must prove knowledge and experience in relation to ethical aspects,
p.000019: methodological and legal clinical research, good clinical practices and clinical practice
p.000019: welfare. They must excuse their participation in the evaluation of research projects in which they could have
p.000019: interest conflict.
p.000019: Art. 64.- The CEISH shall be governed by conventions, declarations, instruments and norms.
p.000019: internationals related to biomedical and bioethical research, due to sanitary regulations
p.000019: specific current and the regulations issued by the National Health Authority.
p.000019: SPONSOR CHAPTER X
p.000019: Art. 65.- The sponsor is the individual, company, institution or organization, including
p.000019: academics, with legal representation in the country, responsible for financing, administration,
p.000019: initiation, development, monitoring and closure of a clinical trial.
p.000019: Art. 66.- In cases in which the insurance policy does not cover all damages, it will be the sponsor who solvent
p.000019: the expenses for the damage that the subjects under investigation have on their health. In addition, the sponsor will be
p.000019: responsible for the economic damages arising as a result of the clinical trial.
p.000019: Art. 67 - If the sponsor is an individual who investigates
p.000019: CHAPTER IX ba or with time with the academy, this will be the one that
p.000019: hire
p.000019: the insurance policy for the risks arising from the
p.000019: OF THE RESEARCH ETHICS COMMITTEES IN HUMAN BEINGS
p.000019: research qu
p.000019: perform.
p.000019: Art. 61.-
p.000019: The
p.000019: Committees of
p.000019: Ethics of
p.000019: Research on
p.000019: Art. 6 .- All sponsors, without prejudice to their responsibility, may delegate a part or the
p.000019: totality of
p.000019: Human Beings, CEISH, are organs linked to a
p.000019: its functions to a single Research Organization by
p.000019: public or private institution, responsible for approving
p.000019: Contract registered in the ARCSA.
p.000019: the investigations involving human beings
p.000019: or that use biological samples. Any clinical trial protocol carried out in the country, before
p.000019: If it begins its execution, it must first be approved by a Research Ethics Committee on Human Beings and
...
p.000019: constituted in the country, where clinical trials are developed, which must comply with the
p.000019: infrastructure, human talent and management requirements established by the ARCSA, which allow the correct
p.000019: study execution These centers must be registered in the National Registry of Centers of
p.000019: ARCSA Clinical Research.
p.000019: Art. 88.- The clinical research centers are responsible for the safety of the subject that
p.000019: Participate in a clinical trial. They will be evaluated before, during and after the clinical trial, by
p.000019: ARCSA inspections to ensure compliance with Good Clinical Practices. Prior to
p.000019: After the start of the clinical trial, the ARCSA will carry out an inspection at the research centers
p.000019: cynical that will participate in the study, to ensure that the conditions of the center
p.000019: i) Perform random verifications of the data registered in the clinical research center.
p.000019: j) Develop a clinical trial monitoring plan and
p.000019: meet the requirements to develop the type of study proposed.
p.000019: Art. 89 - The Research Ethics Committee in Beings
p.000019: verify that this s
p.000019: development in compliance with
p.000019: Hum nos and AR
p.000019: SA must analyze that the center of
p.000019: protocol and its approved modifications
p.000019: in ca o of
p.000019: clinical research count on qualified researchers,
p.000019: have them, as well as the requirements
p.000019: inados by
p.000019: equipment and
p.000019: appropriate means for development
p.000019: the Research Ethics Committee in Hu Beings
p.000019: years
p.000019: del est gave, among them, suitable conditions for
p.000019: by the National Health Authority and Good Clinical Practices
p.000019: k) Review the investigator's file making sure it is complete and up to date and identify errors in
p.000019: case of presenting
p.000019: l) Verify that the backups of all types of resources are recorded in the investigator's file
p.000019: adverse events and reactions, during the development of the clinical trial.
p.000019: m) Review the handling of the product under investigation, its provision and storage conditions, in order to
p.000019: verify if the established in the investigation protocol is fulfilled.
p.000019: n) Verify the existence and application of the procedure for receiving, using and returning the
p.000019: products under investigation in clinical research centers.
p.000019: o) Verify if the correct instructions on research subjects have been provided
p.000019: the use, handling, storage and return of the products under investigation.
p.000019: p) Inform the investigator in writing of errors and deviations from the application of the protocol, in case of
p.000019: have them, as well as the measures that must be implemented to prevent them from recurring.
p.000019: product research soul according to its characteristics; appropriate conditions for
p.000019: consultation and training; guarantee of immediate attention before a potential emergency-medical emergency. From
p.000019: there is no capacity to attend emergencies / emergencies in the clinical research center itself, its
p.000019: benefit must be duly guaranteed by means of a contract or agreement with another health facility, without
p.000019: restriction of any type of attention for the study subjects.
p.000019: CHAPTER XIV
...
p.000019: • Adverse event (EA): any adverse health incident that occurs in a
p.000019: subject or participant in clinical research, to whom a research product has been administered,
p.000019: although it does not necessarily have a causal relationship with the product under study. An adverse event can be, by
p.000019: therefore, any unfavorable and unintended sign (including an abnormal laboratory finding),
p.000019: symptom or illness temporarily associated with the use of a drug or product under investigation, whether or not
p.000019: related to it.
p.000019: • Serious Adverse Event: any event that occurs in the context of a clinical trial, without
p.000019: it is necessarily related to causality with the product under investigation, and that produces: the death of the subject in
p.000019: investigation, put the subject's life at risk, make the subject's hospitalization necessary or prolong his
p.000019: stay, produce permanent or significant disability or disability, or place a
p.000019: Friday, June 30, 2017 - 17
p.000019: commercialization; provide additional information on efficacy, effectiveness and long-term safety (risk-
p.000019: benefit). They are performed under conditions of usual medical practice and in large numbers of subjects during a
p.000019: prolonged period Also known as post-marketing, post-registration or
p.000019: Pharmacovigilance
p.000019: • Inspection: for the purposes of this regulation, the verification or revision action is understood as such
p.000019: developed by the National Health Authority through the National Agency for Regulation, Control and
p.000019: Health Surveillance (ARCSA), to documents, facilities, files, quality assurance systems and
p.000019: Any other resource that ARCSA considers is related to a clinical study.
p.000019: • Nonprofit clinical research: research conducted by researchers without the
p.000019: Participation of the pharmaceutical or pharmaceutical industry that meets the following requirements: 1)
p.000019: Sponsor is the academy, a public hospital, a public research institute or entities
p.000019: public; 2) the ownership of the research data belongs to the sponsor from the first moment of the
p.000019: study;
p.000019: 3) there are no agreements between the sponsor and third parties that allow the use of the data for uses that
p.000019: generate an in ustrial property; 4) design, implementation, recruitment, data collection and
p.000019: the dissemination of research results is kept under the control of the sponsor; and, 4) for their
p.000019: characteristic, these studies cannot be part
p.000019: from a development program for an authorization of
p.000019: congenital anomaly or malformation.
p.000019: • Phase I: research in humans where a substance, new drug, is first used
p.000019: or new formulation to provide preliminary information on product safety and establish the
p.000019: tolerability and feasibility thereof. They are usually performed in healthy volunteers or in
p.000019: Some specific cases in patients. They comprise trials of pharmacokinetics and pharmacodynamics.
p.000019: They guide the most appropriate administration schedule for more advanced clinical trials.
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Searching for indicator placebo:
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p.000019: any aspect of the study, if required.
p.000019: r) The availability of medical treatment and the compensation legally entitled to
p.000019: subject under investigation, according to the insurance policy of the study contracted by the promoter, to cover possible damages
p.000019: caused directly or indirectly by the product under investigation.
p.000019: s) The contact information of the principal investigator and the clinical research center to which the
p.000019: subject under investigation, if there were any health effects related to the clinical study.
p.000019: t) The obligation of the investigator to inform, in verbal and written form, the subjects in
p.000019: investigation or its legal representative, when applicable, any new information or changes
p.000019: in the study protocol that could affect the participant's safety or his decision to continue in
p.000019: the study. In these cases the need to obtain a new consent will be evaluated.
p.000019: u) The obligation to communicate the results of the investigation to the subjects under investigation.
p.000019: v) Data on the Research Ethics Committee in Human Beings that approved the protocol and the possibility
p.000019: to contact the same Committee in case of doubts regarding your right as a participant in the study.
p.000019: Friday, June 30, 2017 - 9
p.000019: CHAPTER V
p.000019: OF THE RESEARCH PRODUCTS
p.000019: Art. 41.- For the purposes of applying this Regulation, the product shall be understood as
p.000019: research, for phase I, II and III studies, drugs in general, biological products and products
p.000019: Natural processed medicinal products, that is, a pharmaceutical form of an active ingredient or placebo
p.000019: which is being tested or used as a reference in a clinical study. For phase IV studies, it will be understood as
p.000019: product under investigation to those indicated above and that have a sanitary registration in Ecuador;
p.000019: when they are used or conditioned in a therapeutic indication or in a manner other than those authorized in the country; when
p.000019: used in combination with other medicines than those authorized; or, in cases where
p.000019: conduct post-marketing studies.
p.000019: Art. 42.- The manufacture or import of the product under investigation, for use in a test
p.000019: clinical, will be authorized by the ARCSA and will be subject to the standards of Good Manufacturing Practices and other standards that
p.000019: This Agency determines for this purpose.
p.000019: Art. 43.- For the manufacture or delivery of a product under investigation, the sponsor shall
p.000019: request the authorization of importation from the ARCSA, specifying at least the type and characteristics
p.000019: Product statistics, place of manufacture, certificate of quality of the lot to be imported, labeling,
p.000019: traceability and transport of the same and must attach the requirements established in the instructions that the
p.000019: ARCSA issues for the purpose.
p.000019: Art. 44.- The sponsor shall submit to the ARCSA the certifications of the product under investigation issued by
p.000019: the department of quality of the pharmaceutical company do de said product is being produced, so
p.000019: such as batch releases with their stability and the extent of
p.000019: w) Report that a
p.000019: once finished
p.000019: the investigation,
p.000019: Stability, if applicable.
p.000019: After data analysis, the promoter will deliver the product under investigation for free in the
p.000019: following cases: if its effectiveness is demonstrated; and, when its suspension jeopardizes the safety of the
p.000019: subject under investigation and there is no therapeutic option that can replace the study treatment
p.000019: in the market and until the product is marketed in the country.
p.000019: Art. 40.- In cases where the use of placebo is authorized in a clinical study, prior to obtaining the
p.000019: informed consent of the participants, they will be informed with sufficient time and clearly in what
p.000019: This process consists.
p.000019: The use of placebo should be considered in cases where there is no therapy, intervention,
p.000019: medication or procedure of proven efficacy for the problem investigated; and in others it must be analyzed
p.000019: on a case-by-case basis by the CEISH and by the ARCSA, in order to minimize risks and not affect the safety of
p.000019: subjects under investigation, ensuring that they do not run additional risks, serious adverse effects or damages
p.000019: irreversible as a result of not receiving the best proven intervention.
p.000019: Art. 45.- In the event that the product under investigation is manufactured in the country, the ARCSA will carry out inspections.
p.000019: to verify the manufacturing process.
p.000019: Art. 46.- The laboratory manufacturing the product under investigation must comply with the Standards of
p.000019: Good Manufacturing Practices established by national regulations for the elaboration of a product
p.000019: pharmacological, presenting the different quality and stability certifications in the product file
p.000019: of the drug.
p.000019: The product under investigation must be properly labeled on the primary container with ink
p.000019: indelible in Spanish language, indicating at least the data that identify the sponsor, to the clinical trial
p.000019: and to the product under investigation and its expiration date, protocol code, product code,
p.000019: lot number, number of units and dosage form, route of administration, storage conditions,
p.000019: conservation and use thereof. Additionally, the labeling must specify the phrases “Prohibited its
p.000019: sale ”and“ product for exclusive research use ”. In the case of primary packaging
p.000019: 10 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
...
p.000019: Art. 48.- Surplus and / or expired research products at the conclusion or suspension of the trial
p.000019: clinical, should be destroyed by the sponsor or his delegate, according to the procedure established in the
p.000019: corresponding regulations.
p.000019: Leftover reagents not used in the investigation that are in good condition may be
p.000019: donated, in accordance with current regulations.
p.000019: Art. 49.- It may be exempted from the destruction referred to in the previous article to the products in
p.000019: investigation, prior authorization of the ARCSA, in the following cases:
p.000019: a) When the product is not expired and can be used for exceptional cases in patients whose
p.000019: Life is at risk.
p.000019: Art. 52.- The sponsor will keep a detailed record of all adverse events that the investigator will
p.000019: notify. In the event of an unexpected serious adverse reaction or a serious adverse event,
p.000019: the sponsor or the Contract Research Organization contracted, must notify the ARCSA, in both
p.000019: (2) following days of known, by any means of communication, using the format defined for this purpose
p.000019: (Annex 5)
p.000019: Art. 53- After the notification of a serious adverse event or a suspicion of an unexpected serious adverse reaction, in the
p.000019: within seven (7) days as of the fact known, the investigator must send a partial report to the
p.000019: ARCSA and within fifteen (15) days, will send the corresponding full report.
p.000019: Art. 54.- From the beginning of the clinical study, the sponsor will present annually to the ARCSA,
p.000019: During the study, a report on the safety of the medicines used in their trials
p.000019: clinical, which also includes each medication in unregistered research and the placebo, if this is
p.000019: used.
p.000019: Art. 55.- The ARCSA will maintain a pharmacovigilance system to monitor the
p.000019: reports of serious adverse events and about unexpected serious adverse reactions. A clinical assistant can
p.000019: be suspended by the ARCSA justifiably, after the analysis of the
p.000019: b) When delivered in donation, by means of an agreement
p.000019: number, graveda
p.000019: and frequency
p.000019: of adverse events, the
p.000019: between the sponsor and the beneficiary institution of the
p.000019: type of study and population of
p.000019: test, and inspection
p.000019: donation, only e
p.000019: the cases in which the product
p.000019: corresponding, in order to precautionary the security of
p.000019: have a sanitary record and the purpose of the gift
p.000019: the subject
p.000019: del es udio, d
p.000019: compliance with regulations
p.000019: be your employment, according to the conditions of us in the sanitary registry.
p.000019: CHAPTER VI
p.000019: approves
p.000019: that for the effect or issue the ARCSA.
p.000019: CHAPTER VII
p.000019: ON THE USE OF MEDICINES IN
p.000019: OF THE NOTIFICATION OF E
p.000019: ADVERSE BETWEEN
p.000019: CLINICAL RESEARCH
p.000019: AND REACTIONS ADVE SAS
p.000019: Art. 50.- The principal investigator must notify the ARCSA, the sponsor or the Organization of
p.000019: Contract Research and the corresponding Research Ethics Committee in Human Beings, all
p.000019: serious adverse events and all suspicions of unexpected serious adverse reactions that occur during
p.000019: the clinical study, in a period not exceeding twenty-four (24) hours after the event was known, as well
p.000019: such as abnormal laboratory results that the protocol considers determinants and that may influence the
...
p.000019: pharmacological effect of new drugs and new therapeutic regimens are identified.
p.000019: Its main objective is to provide preliminary information on the effectiveness of the product and expand the
p.000019: safety data obtained in previous studies. They are performed on patients affected by a certain
p.000019: disease or pathological condition under strict monitoring.
p.000019: • Phase III: research in human beings aimed at assessing the efficacy and safety of
p.000019: experimental treatment, trying to reproduce the usual conditions of use and considering the
p.000019: therapeutic alternatives available in the indication studied. They are controlled and randomized and ideally to
p.000019: triple blind They constitute the gold standard to evaluate new therapeutic alternatives.
p.000019: • Phase IV: investigations in human beings that are carried out once the product in
p.000019: investigation has obtained the sanitary record authorizing its
p.000019: Productization of a product.
p.000019: • Stigner's manual: it is a compilation of the clinical and non-clinical data of the
p.000019: product under investigation, which are relevant for the study of it in humans. Your goal is
p.000019: provide researchers and other people involved in the study with the information to
p.000019: facilitate the understanding of the foundation and the fulfillment of several important characteristics of the
p.000019: protocol, such as dose, frequency / dose range, administration methods and monitoring procedures for
p.000019: security.
p.000019: • Monitor: Qualified person to follow up the process of a clinical study and ensure that it
p.000019: be conducted, recorded and reported in accordance with the protocol, standard operating procedures, Good
p.000019: Clinical Practices and applicable regulatory requirements.
p.000019: • Placebo: Product with pharmaceutical form, which contains a pharmacologically inert substance that
p.000019: acts as a comparator in a clinical study, without it having specific pharmacological activity for
p.000019: condition studied.
p.000019: • Standard Operating Procedures (SOPs): Detailed and written instructions for
p.000019: achieve uniformity in the execution of a specific function.
p.000019: • Serious adverse reaction: Any adverse reaction that at any dose causes death threatens the
p.000019: life of the subject under investigation, produces permanent or substantial disability, requires hospitalization
p.000019: 18 - Friday, June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: or prolongs hospitalization time, causes anomaly or congenital malformation.
p.000019: • Serious and unexpected adverse reaction: Reaction whose nature, severity or outcome are not consistent
p.000019: with the reference safety information of the product under investigation.
p.000019: GENERAL DISPOSITION
p.000019: FIRST.- The National Agency for Regulation, Control and Health Surveillance - ARCSA will verify in
p.000019: the entire national territory, compliance with the suspension or cancellation of trials
p.000019: clinicians that run in the country and if necessary will request support from their Zonal Coordinations.
p.000019: SECOND.- If necessary, within the approval, control and surveillance processes of a clinical trial, the
p.000019: ARCSA will request additional information from the sponsor described in this instrument.
p.000019: THIRD.- In the case of import and / or export of biological samples for the purpose of
p.000019: investigation, the sponsor must request the corresponding authorization from the ARCSA, which will issue it
...
Orphaned Trigger Words
p.000019: and when it does not imply damage to the health or life of the subjects
p.000019: and the documentation presented c mplen with all l s
p.000019: In est gación.
p.000019: requirements established in this Regulation or, will prepare the corresponding technical report, regardless of
p.000019: whether or not it is favorable to the approval of the proposed study. This report will be sent by the Agency to the Technical Committee
p.000019: Clinical Research Advisor, an instance created in this instrument, to support specifically
p.000019: and specialized in the evaluation process of a clinical trial.
p.000019: Art. 11.- The ARCSA will have sixty (60) term days from the date the procedure was admitted,
p.000019: for the issuance of the evaluation report of the research protocol and will communicate to the applicants, through
p.000019: its Executive Director, the approval, non-approval or request for further information regarding the clinical trial
p.000019: In analysis. Only in case of phase IV clinical trials, the report will be issued in forty-five (45) days
p.000019: term, counted from the date it was admitted for processing.
p.000019: Nonprofit clinical trials and those sponsored by state entities, or by the
p.000019: alliance between a public institution and a private institution will have priority attention times,
p.000019: this is forty five
p.000019: (45) days after receiving all the documentation requested by the ARCSA, for phase I, phase II and phase tests
p.000019: III.
p.000019: Art. 12.- In the event that the documentation presented does not meet the requirements for approval
p.000019: of the clinical trial, the ARCSA will notify the applicant within
p.000019: Art. 16.- To authorize an amendment to the clinical documents, the ARCSA will analyze at least the following:
p.000019: a) The protocol, the investigator's manual and the informed consent that include and
p.000019: highlight the changes, in relation to the approved version.
p.000019: b) The justification and technical argumentation of the changes made.
p.000019: c) The approval of the changes by the Research Ethics Committee in Human Beings that approved the
p.000019: clinical trial protocol, where applicable.
p.000019: Art. 17.- If the ARCSA needs to clarify information or complete documentation in a process of modification of
p.000019: a clinical trial, the applicant must respond within thirty (30) days, counted from
p.000019: Received the notification in which you are required to submit the documentation. In case of not getting an answer
p.000019: The process will be terminated automatically. If a proposed change was not duly justified, and
p.000019: ARCSA issued a negative response on two (2) occasions, no further modification requests may be made
p.000019: About that change.
p.000019: Art. 18.- The approval of a clinical trial will be valid for the period that lasts the same, unless the ARCSA
p.000019: Justifiably revoke such approval.
p.000019: 6 - Friday June 30, 2017 Special Edition No. 23 - Registration
p.000019: Official
p.000019: Art. 19.- The ARCSA may carry out inspections of the establishments or review the documentation.
p.000019: related to a clinical trial in execution, when there is any request for modification to it, which
p.000019: It could cause the response to that request to be conditional on the results of the inspection.
p.000019: Art. 20.- In order to protect the rights and well-being of the subjects under investigation, the ARCSA will carry out
p.000019: inspections to any instance related to the execution of an approved clinical trial in the country, the
p.000019: times that it considers pertinent, before, during or after the execution of the same, with or without notice
p.000019: prior, according to the type of inspection performed; and, in order to verify compliance with
p.000019: the Standards of Good Manufacturing Practices, Good Clinical Practices and Good Practices
p.000019: Laboratory practices.
p.000019: Art. 21.- Inspections may be carried out at the clinical research center, at the place of manufacture of the
p.000019: product under investigation, to the facilities of the sponsor, to the facilities of the Organization of
p.000019: Contract Research or the Research Ethics Committee on Human Beings that approved the protocol. The
p.000019: ARCSA will define the particular conditions under which inspections will be carried out.
p.000019: Art. 22.- The inspectors of the ARCSA, in forty-five (45) days after the completion of the
p.000019: inspection, submit a report to the sponsor of the clinical trial and the inspected place on the
p.000019: Conformities or disagreements found in relation to Good Clinical Practices (PCB), which determines whether or not
p.000019: The continuity of the clinical study.
p.000019: Art. 23.- In case of non-compliance of the BPCs that attempt against the safety and well-being of
p.000019: participant in the investigation, the corresponding clinical research center, or if applicable, the
p.000019: clinical study, will be suspended. The sponsor will establish a plan of measures to be taken to correct the
p.000019: nonconformities, which will be sent through a written report to the ARCSA, within a term of forty-five
p.000019: (45) days, as of the receipt of the communication of non-compliance of said Regulatory Agency.
p.000019: Art. 24.- If after an inspection it is verified that there are no circumstances that threaten the
p.000019: Research participant safety, the study will continue its course. However, in a term of forty and
p.000019: five (45) days from the receipt of the ARCSA report, the sponsor must correct the
p.000019: observations.
p.000019: Art. 25.- After the inspection, if the ARCSA finds that there are circumstances that put at risk
p.000019: The integrity of the participant will apply corrective measures, including:
p.000019: a) Provide for the separation of researchers from the execution of the clinical trial, if they do not comply with the PCBs in
p.000019: the study.
p.000019: b) Suspend a clinical research center as executor of a clinical trial, if it does not comply
p.000019: with
p.000019: Good Clinical Practices and attentive to the safety of research participants.
p.000019: c) Demand training in BPC from professionals and staff participating in the trials, when considered
p.000019: necessary.
p.000019: d) Establish deadlines for compliance with the plans to solve the nonconformities detected by the
p.000019: ARCSA during the inspections you perform.
p.000019: e) Temporarily or definitively suspend the start / execution of a clinical trial, according to
p.000019: corresponding, due to the lack of guarantees for the security of the subject under investigation.
p.000019: f) Revoke the approval of a clinical trial at any stage, if there is no security for
p.000019: Research participants
p.000019: g) Others deemed necessary.
p.000019: Art. 26.- The ARCSA will suspend or cancel a clinical trial that is being carried out in the country and will revoke the
p.000019: approval granted, depending on the severity of the case, for the following causes:
p.000019: a) Prevent by any person related to the clinical trial, the actions of the inspectors of the
p.000019: ARCSA
p.000019: b) Use a product under investigation in humans for approval of the clinical trial protocol
p.000019: by the ARCSA.
p.000019: c) R alizar the clinical trial without adjusting to the content of the protocols on the basis of which
p.000019: granted approval or modifications to the research protocol authorized for the trial
p.000019: clinical or make amendments to it, without prior authorization from the ARCSA.
...
p.000019: the following:
p.000019: a) Select and hire qualified researchers for their training, training and / or experience
p.000019: to participate in a clinical trial, as well as select clinical research centers
p.000019: that have all the necessary resources for the clinical trial to be developed, following the
p.000019: Good Clinical Practices and guaranteeing the safety of the subject under investigation.
p.000019: i) Timely inform the participants of the trial, the researchers, the Committee of
p.000019: Research Ethics in Human Beings and ARCSA on new findings and updated information regarding the
p.000019: product or products under investigation.
p.000019: j) Notify ARCSA of suspected serious adverse reactions or events
p.000019: serious adverse effects that may affect the benefit-risk ratio of the clinical trial, taking urgent measures to
p.000019: security to protect test subjects.
p.000019: k) Provide free of charge to the study participants the product under investigation and the
p.000019: auxiliary medications, and provide coverage for the complementary exams that are required during the
p.000019: clinical trial development.
p.000019: l) Designate a national monitor that will monitor the development of the clinical trial and have a
p.000019: appropriate monitoring system.
p.000019: m) Send timely monitoring reports to the clinical trial to the ARCSA.
p.000019: n) Submit a progress report to ARCSA at least once a year and when required by said Agency
p.000019: on and unfolding the clinical trial, as well as
p.000019: b) Verify that the investigated
p.000019: principal has obtained the
p.000019: the final report of it.
p.000019: Approval of the protocol for the development of the clinical trial by a Research Ethics Committee in
p.000019: Human Beings approved by the Ministry of Public Health.
p.000019: c) Request ARCSA approval for the start and development of the clinical trial, attaching the requirements
p.000019: established for this purpose. In the event that the sponsor is a foreigner, the request will be made
p.000019: the Contract Investigation Organization that legally represents you in Ecuador.
p.000019: d) Verify that all documentation and procedures comply with the requirements of Good
p.000019: Clinical Practices and regulations related to the subject.
p.000019: e) Contract an insurance policy in favor of the subjects under investigation and deliver the
p.000019: corresponding financial compensation, if any damage is demonstrated and its causal relationship with
p.000019: The product under investigation.
p.000019: f) Provide the researcher with the “Investigator Manual”.
p.000019: g) Ensure strict compliance with the protocol through the clinical study monitoring.
p.000019: h) Record, process, manage and keep the clinical trial information in order to communicate, interpret and
p.000019: accurately verify the results of the investigation, ensuring the confidentiality of medical records and
p.000019: the personal data of the test subjects.
p.000019: o) Ensure that the products under investigation have been developed in compliance with the Good Practices Standards of Man
p.000019: fa tur and the regulations established by the ARC A, and that are provided with a label that
p.000019: Identify as “Prohibited its sale” and “product for exclusive use in research”.
p.000019: p) Keep a main file of the clinical trial with all the documentation related to its realization.
p.000019: This file will be kept and will be available to the ARCSA and the Ministry of Public Health when
p.000019: request, during the following seven (7) years after the end of the investigation in the country.
...
p.000019: The principal investigator must prove that they have participated in at least one previous clinical trial and
p.000019: have certificates with academic endorsement of training in Good Clinical Practices and Ethics of the
p.000019: Investigation.
p.000019: Official Registry - Special Edition Nº 23
p.000019: Art. 91.- The responsibilities of the principal investigator in the clinical trial are:
p.000019: a) Know in detail the research protocol and all available information about the product
p.000019: in research.
p.000019: b) Know and comply with Good Clinical Practices and applicable national health regulations.
p.000019: c) Obtain, prior to the start of the clinical trial, the letter of declaration of institutional interest of
p.000019: execution of the study, signed by the legal representative of the health establishment in which
p.000019: will develop the same.
p.000019: d) Obtain the informed consent of the subjects participating in the study.
p.000019: e) Obtain the approval of the protocol, of the informed consent, of the Manual of
p.000019: Researcher and other documents described in Good Clinical Practices, by a
p.000019: Research Ethics Committee on Human Beings approved by the Ministry of Public Health, prior to
p.000019: Start of clinical trial.
p.000019: f) Select the personnel involved in the clinical trial and verify that it is properly
p.000019: informed and trained regarding the study.
p.000019: g) Clearly establish the procedures to follow
p.000019: Friday, June 30, 2017 - 15
p.000019: during the development of the clinical trial to the ARCSA, the sponsor or the Research Organization
p.000019: by Contract, as appropriate and to the Research Ethics Committee on Human Beings that approved the protocol
p.000019: of investigation, observing the established reporting periods, according to the severity of the event or the
p.000019: adverse reaction.
p.000019: o) Ensure that the informed consent complies with the provisions of this Regulation.
p.000019: p) Take the necessary measures to guarantee the protection of the confidentiality of the information
p.000019: of the subject under investigation and the data obtained in the clinical trial.
p.000019: q) Facilitate the inspection visits of the sponsor, of the monitor, of the Ethics Committee of Research in Beings
p.000019: Human or ARCSA before, during or at the end of the clinical trial.
p.000019: r) Present the partial reports and the final report to the sponsor, as well as other reports that
p.000019: are requested by the ARCSA, in relation to the development of the clinical trial based on the protocol d
p.000019: Authorized investigation
p.000019: s) Prepare a progress report of the clinical trial, at least once a year, to deliver it to the
p.000019: sponsor, to the Research Ethics Committee in Human Beings
p.000019: in the event of any situation that may arise and the functions that may be delegated to the members of the
p.000019: and to the A
p.000019: CSA
p.000019: research team, among others, storage t) Dedicate, according to the complexity of the
p.000019: research and the
p.000019: of the product in
p.000019: research and the
p.000019: management
p.000019: subject number
p.000019: in research, the necessary time
p.000019: documentation. to cum lir with him
p.000019: role of principal investigator.
p.000019: h) Ensure that the study is carried out according to the authorized research protocol and that the
p.000019: Product under investigation is stored, dispensed and used as established in said protocol.
p.000019: i) Take the necessary measures so that the recruitment process of the participants in the
p.000019: investigation, be carried out in accordance with the provisions of the authorized research protocol.
p.000019: j) Ensure the safety of the subjects under investigation and adequately monitor the treatment to which
p.000019: undergo, in order to identify possible adverse reactions and adverse events that could
p.000019: alter your health conditions.
p.000019: k) Take responsibility for the medical decisions taken with the subjects under investigation, in
p.000019: relationship with the clinical trial and, in case of presenting any possible adverse event, ensure that
p.000019: Research subjects receive appropriate medical attention.
p.000019: l) Take responsibility for the custody and handling of the product under investigation.
p.000019: m) Keep all records and documents corresponding to the clinical trial updated.
p.000019: n) Submit safety reports, including reports of serious adverse events and suspicions
p.000019: of unexpected serious adverse reactions that occur
p.000019: CHAPTER XV
p.000019: OF THE TECHNICAL ADVISORY COMMITTEE ON CLINICAL RESEARCH
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| army | Soldier |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| children | Child |
| criminal | criminal |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| emergencies | patients in emergency situations |
| emergency | Public Emergency |
| family | Motherhood/Family |
| gender | gender |
| healthy volunteers | Healthy People |
| illiterate | Literacy |
| illness | Physically Disabled |
| indigenous | Indigenous |
| influence | Drug Usage |
| language | Linguistic Proficiency |
| opinion | philosophical differences/differences of opinion |
| placebo | participants in a control group |
| pregnant | Pregnant |
| property | Property Ownership |
| single | Marital Status |
| substance | Drug Usage |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| drug | ['influence', 'substance'] |
| influence | ['drug', 'substance'] |
| substance | ['drug', 'influence'] |
Trigger Words
capacity
coercion
consent
cultural
ethics
justice
protect
protection
risk
volunteer
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input