Guołemolo, THURSDAY, February 22, 2007
MIEfIG '¥' ERIO DE GAkŁfDP ziB> zCA ASEG ‘¥’ AND ICEA GOC7A
DIAI2IO of CENTRO AMÉAÌCA
NUMBER 25
approval / favorable opinion of the study protocol, the capacity of the researcher (s) and
adequate supply of the facilities, methods and material to be used in obtaining and documenting the
informed consent of the subjects of the state.
2.8. Comparator (product). Research or marketed product used as reference for a trial
clinical.
.NsAvosmLlmcosE N'eUm N s. '
FOR THE REGULATION OF THE
2.s. Informed consent. Process through which a subject voluntarily confirms his decision to
participate in a particular school, voluntarily adopted by a person capable of giving
consent after being
MINISTERIAL AGREEMENT SP-M-466-2007
THE PUBLIC HEALTH MINISTER
AND CONSIDERING SOCIAL ASSISTANCE. '
Oue the Political Constitution of the Republic recognizes that the enjoyment of health is a fundamental right of being
without discrimination, and obliges the State to ensure it, developing through
its institutions preventive actions. recovery and rehabilitation, in order to provide the habit before
the most complex physical, mental and social well-being, also recognizing that the health of the inhabitants of the
nation is a public good.
CONSIDERING:
That it is the competence and responsibility of the State regarding manufacturing. marketing, surveillance
and control of pharmaceutical and related products to contribute to the existence of products
safe, effective, quality, correctly identified and with appropriate information; understanding each other
within this activity the authorization of clinical tests, which in order to be carried out
must be evaluated by the Commission for the Evaluation of Clinical Trials, informed according to a Ministerial Agreement
SP-M-2264-2004, in accordance with Article ninety four of the Regulations for Health Control
of Medicines and Related Products; therefore, in compliance with the established, it is intended to make a
technical proposal for the evaluation and approval of clinical trial protocols with drugs and all
related to your development.
SO:
In exercise of the functions conferred on him by Articles 194 literal a) and g) of the Political Constitution of
the Republic of Guatemala; and 27 literal m) of the Law of the Executive Organism, Decree number 114-97 of the
Congress of the republic.
AGREES:
Issue the regulatory presenle:
FOR THE REGULATION OF CLINICAL TRIALS IN HUMANS
CHAPTER I
GENERAL DISPOSITION
2.1. Accreditation. Declaration by means of the issuance of a certificate, in which the competent authority,
auloriza the execution of activities of a Comilé de Élica in research, after having verified that
he himself complies with all the requirements set out in the current regulations. ”
z.2. Quality assurance. All those planned and symbolic actions that
established to guarantee that the study is being carried out and that the data is generated.
Documented (registered) and reported in c. implemented with the 6 Good Clinical Practice (PCB) and the
applicable regulatory requirements.
8. Random Assignment. Process of assigning study subjects to treatment groups
or control using chance to determine allocations to reduce bias.
2.4. Audit. A systematic and independent examination of related activities and documents
with the study to determine if the evaluated activities were carried out and the data were recorded,
analyzed and reported accurately according to protocol, standard operating procedures
Sponsor's (POEs), Good Practice Clinics (BPC) and apiicabies regulatory requirements.
2.5. Good clinical practices (PCB). Standard for design, conduction, realization, monitoring,
audit, registration, analysis and reporting of clinical studies that provides a guarantee that the data and
Reported results are credible and accurate and that the rights, integrity and confidentiality of
study subjects.
2.6. Commission for the evaluation of clinical trials. Governing body in * the authorization to carry out
a clinical trial protocol, and in the course of this legal body it will be called THE COMMISSION.
2.7. Investigative Ethics Committee (cEl). Independent organization, made up of professionals
Physicians / Scientists and non-medical or non-scientific members, whose responsibility is to ensure protection
of fas rights. the safety and property of the human beings involved in a study and
provide a public guarantee of that protection. through, enter other houses. of the review and
carefully informed and documented about its nature. imporlancia. implications, risks,
alternative treatments available, the confidentiality of the information,
the rights of persons and responsibilities in accordance with the Declaration of Helsinki. At
supposing that the subject has an impediment to write, the consent may be smelled at home
exceptional orally in the presence of at least one whip.
When the subject of the trial is not a person capable of giving his consent, the decision must be made by
your legal representative after having been informed about all relevant aspects of it
to take the "decision to participate. Informed sentiment is documented through a form of
written, signed and dated informed consent.
2.10. Source documents. Original documents, data and records (for example, hospital records, sheets
clinical, lab notes, memoranda, subject journals, or evaluation checklists,
pharmacy delivery records, recorded data from automated instruments, copies or
After verifying cerlified transcripts that are exact copies, microfiche. negatives
photographic. magnetic or microfilm media, x-rays, subject files and records kept in
the pharmacy in the laboratories and in the medical-technical departments involved in the study. clinical).
2.11. Amendment to the protocol. A written description of a formal change or clarification of a protocol.
2.12. Clinical trial. All research or experimental evaluation of a substance, medicine or
device, through its application to human beings, oriented towards one of the following lines:
and. Show its pharmacodynamic effects or collect data regarding its absorption,
distribution, metabolism and excretion in the
human organism.
b. Establish its efficacy for a specific therapeutic, prophylactic or diagnostic indication.
c. Know the profile of your adverse reactions and establish your safety.
The administration of the drug or medication to a single patient in the setting of the clinic is not considered a clinical trial.
habitual medical practice for the sole purpose of obtaining a benefit for it. Medical practice and
professional freedom of prescription of the doctor will not protect, in any case, clinical trials not
ar ›Iorized, or the use of secret or undeclared remedies to the sanitary authority.
2.J 3. Open-blind clinical trial. It is the one in which the subject lants as the researcher knows the group of
tralamienlo to which he has been assigned.
2.14. Clinical trial with third-party evaluation. It is one in which the subject, researcher and
palroclnador, ignore the treatment received. To evaluate the response, a third person is used who
the treatment each subject is receiving is unknown.
2.1s. It is cynical with crossed groups. It is the one in which the experimental and control treatments are
administered to each individual in successive periods that have been determined randomly, to which
allow each subject to be their
2.16. Clinical trial with parallel groups. It is one in which one or several groups of subjects are
assigned to receive the experimental treatment at the same time as the other group receives the control treatment.
2.17. Controlled clinical trial. It is the one that establishes a comparison with a control group or tesligo. The
randomized controlled clinical trial including at least two groups of volunteers,
2.1s. patient or healthy. whose assignment to an experimental or control treatment is carried out at random so that
Neither the subject nor the doctor responsible for their selection or treatment can influence their assignment. So the
Selection of subjects as the periods of treatment and follow-up should take place simultaneously in all
groups. In the vast majority of cases it is the only scientifically valid way to assess efficacy and safety
of a lerapêutica intervention.
2.19. Double-blind clinical trial. It is one in which both the subject and the researcher are unaware of the
assignment to Nos treatment groups.
2.2o. Phase 1 clinical trial. They are the first step in the investigation of a substance or
new medicine in humans, they are also studies of pharmacokinetics and pharmacodynamics] that will provide
Preliminary information on the effect and safety of the product on healthy subjects or in some cases-
in patients, and will guide the most appropriate administration regimen for subsequent trials.
2.Z1. Phase II clinical trial. They represent the second stage in the evaluation of a new substance or
medicine in humans. These will be carried out in healthy subjects or in some houses in patients, their end
is to provide preliminary information on the effectiveness of the product, establish the relationship between the responses
of the same. to know the variables used to measure efficacy and extend the safety data obtained in the
lass 1. In general, these clinical trials will be controlled and randomized to the treatments.
NUMBER 2.S CENTER DIARY
AMERICA Guotemolo, THURSDAY, February 22, 2007
2.43. Standard operating procedures (POEs). Written instructions to achieve uniformity in
the execution of a specific function.
2.44. Produc to in In vestlgaclón. Pharmaceutical form of an active ingredient, placebo or device, which
usanda is being tested as a reference in a clinical study, including a product with a
marketing when used or packaged (formulated or packaged) in a manner unlike
approve ‹›. when used for an unapproved indication or when used for
2.23. Phase IV clinical trial. They are those that are made with a medicine
after its commercialization. These tests may be similar to those described
Obtain more information about a previously approved use.
ocolo. It is defined as the document where the reason for being is described
in phases I, II and III if they study some aspect not yet evaluated or different conditions of use of the authors
hoisted as it might be a new indication. These studies
2.45. Prot
of the day, its objectives, design, methodology,
statistical considerations and the
to the original protocol, to its
they will preferably be controlled and randomized.
2.24. Multicenter clinical trial. It is one conducted according to a single protocol but in more than one
place and, therefore, carried out by more than one
organization of a trial. The term protocol is highlighted
successive versions and their modifications.
2.4s. Adverse drug reaction (ADR). This clinical experience before
approval of a new medicinal product or its new uses, particularly
investigator.
when the therapeutic dose cannot be established.
They should be considered
2.25. Uncontrolled clinical trial. It is the one that cannot be compared with a control or control group.
2.26. Clinical trial photo. It is the one that is carried out as a previous step to other broader studies with
the purpose of knowing data that allows a more adequate design, establishing its viability, as well as
determine the size of the sample for further studies.
2.27. Sequential clinical trial. It is the one in which testing a
adverse medium reactions, all harmful and unintended responses to a medicinal product
related to any dose. The phrase "responses to a medicinal product" means that a causal relationship
between a medicinal product and an adverse event is at least a reasonable possibility, that is, that the relationship
can be discarded. Regarding medicinal products on the market: a response to a medicine that
is harmful and unintentional and occurs at doses normally used in man for prophylaxis,
dlagnôsllco or treatment
from diseases to for modification of the łisiołógica function.
specific hypothesis, the number of subjects is not predetermined in advance, but
2.47. Unexpected drug adverse reaction:
adverse reaction whose
It depends on the results that are obtained throughout it.
2.28. Simple clinical trial clergy. It is the one in which the subjects do not know the allocation to the group of
treatment, but not the investigator.
2.29. Unlcêntrlco cylindrical test. It is that carried out by a single Investigator to a research team in
a central dream.
z.ao. Observational study. Analytical epidemiological study in which the researcher does not determine
the allocation of the subjects to each group, but is limited to recording (observing) what happens in the
reality.
2.31. Experimental assessment. It is that study in which an unauthorized substance is used as a specialty
pharmaceutical or a pharmaceutical specialty is used under conditions of use other than those
authorized; also is that
Nature to severity does not correspond to the reference information on the product.
2.48. Subscriber subinves. Any individual member I from the designated and supervised clinical study group
by the researcher at a site where the study is carried out to carry out the critical procedures
related to the study and / or makes important decisions related to that.
2.50. Vulnerable subjectsG. Individuals whose desire to participate in clinical study may be influenced
by the explanation, justified or not, of the benefits associated with their participation, or a
revenge on the part of the members
study in which subjects are assigned to one or more therapeutic intervention groups in a
random, or is conditioned, directly or indirectly. the
superiors of a hierarchy in order to refuse to participate.
members of a group with a hierarchical structure, such as
students of
usual medical prescription process.
z.1z. Adverse event (EA). Any unfavorable medical event that occurs in a patient or subject of
a clinical investigation to whom a pharmaceutical product was administered and who does not necessarily have a relationship
causal with that treatment. Therefore, an adverse event can be any unfavorable sign and not
disabled (inducing an abnormal laboratory finding). Sloma or temporally associated disease
with the use of a medicinal (research) product, whether or not related to it.
2.13. Serious Adverse Event (EAS) or Serious Adverse Drug Reaction (Serious RAM). Any event
adverse or adverse reaction that, at any dose, produces death, threatens the life of the subject, makes
necessary hospitalization or prolongation, causes permanent or significant disability or incapacity, or
give rise to an abnormality or congenital mallormaciõn.
2.16. Case report form (FRC). Printed, optical or electronic document designed to
record all the information required in the protocol to be reported to the sponsor on each subject of the
study.
2.57. Inspection. Official review by a regulatory authority of documents, facilities, record and
any other resource that the authorities consider is related to the clinical study and that may be
located at the site where the study is carried out, at the facilities of the sponsor and / or the
Investigative organization by contract (OIC) or at other sites than regulatory authorities
consider appropriate.
2.18. investigator. Person responsible for conducting a clinical study. If a study is conducted by
a 9 group of individuals, the researcher is the leader responsible for the group and will be called the researcher
principai.
2.40. Monitor. Professional trained with the necessary clinical competence, chosen by the sponsor, who will
In charge of direct monitoring of the conduct of the trial. Serves as a link between the sponsor and
the principal investigator, when they do not confer in the same person.
2.41. Investigation Organization by contract. Legal entity or organization (commercial, academic or other
type) against by the employer to carry out one or more of the workings and functions of the related sponsor
with the study.
2.42. Sponsor. Individual, company or ’entity, institution or organization
responsible for the lniclb, completion, management and / or financing of a clinical trial.
medicine, dentistry, chemical-biological-biological and in fermeria, personal
Sub-ordinate of hospital and laboratory, employees of the pharmaceutical industry, members of the forces
armed and people who are detained / detained. Olrog vulnerable subjects include patients with disease
incurable people
in asylums, unemployed or indigent. patients in emergency situations. ethnic minority groups, people
homeless, nomads, refugees, minors and those who cannot consent.
z.st. Impartial Testłgo. Independent study person, who cannot be influenced in bad faith by the
personnel involved in the study, who are present in the process of obtaining informed consent.
z.sz. Compassionate use. Use of a medicine or product in isolated patients, regardless of
a clinical trial. Specialties are included
tarmacêuticas for indications or conditions of use different from those aulorizadas, under the responsibility
exclusively for a doctor who considers essential his
utilization.
CHAPTER II
PROTECTION OF CLINICAL TRIAL SUBJECTS
Article 3. Respect for the ethical postulates. Only a clinical investigation may be initiated,
when THE GOVERNMENT has annulled the research protocol, considering that the final project
meets all the requisites within which is the review and approval of an Ethics Committee in lnv
accredited research independent of the interests of the investigation. Based on the benefits
expected for the test subject and society justify the risks; likewise, only
continue st compliance with this criterion is permanently monitored.
Article S. The participation of the subjects in the investigation is voluntary. The participating subject in -a
Research or its representative, may revoke your consent at any time, without expression
of causes, without this deriving for him any liability or damage.
All parties involved in an investigation into human beings will keep the strictest
confidentiality. in such a way that the personal and family intimacy of the participating subjects in
there.
Likewise, appropriate measures should be taken to prevent access by unauthorized persons to
Investigation data. The COMMISSION, the Research Ethics Committee that approved the protocol,
The sponsor and national and / or international health regulatory agencies will have access to documents and
regintros related to investigations when requested.
1 2 Guatemala, JU5VčS February 22, 2007 CENTRAL AMERICA JOURNAL
ISSUE 25
Article 6. All people have the right to receive a fair and equitable kato.
In the extraordinary houses of Investigations without therapeutic purposes in minors and in the selection of the subjects
ponlclpantas an una lnvoellgäcîón u •• •• d • b •• incapaceg o people
- In the case of autonomous competition, the distributions will be taken equally, so that there is no
groups exposed to ransom measures necessary to prevent impairment in their
health and the possible exploitation of the elderly. All research with human subjects must have an approach
these subjects.
Valid science and design in a well-developed protocol, which guarantees quality
of the study, in addition, the protection of vulnerable subjects, compensation and treatment for injuries to
participants.
Article 7. In vulnerable populations, investigations may only be carried out when they are of the highest interest.
for your particular Galud. Investigations with said subjects can only be carried out when the
all the following requirements:
7.1. Have sufficient scientific data and, in particular, pharmacological and toxicological tests
in animals, which guarantee that the risks involved in the person in which it is carried out are admissible.
7.z. That the study is based on the available knowledge, the information sought, presumably,
an advance in scientific knowledge about humans or to improve their health and design
mlnlmlce the risks for the subjects participating in êl-.
7.z, That the foreseeable risks and inconveniences for the trial subjects have been weighted and are
lower than the foreseeable benefits for each trial subject and future patients.
Unless proven otherwise, it is presumed that the damage that affects the health of the person being tested, during the
performance of the same and that they persist after the study is completed, have occurred as a consequence of the trial.
The damages that affect the subjects after the end of their participation in the clinical trial must be analyzed.
by the researcher to determine the link between the damage produced and the clinical trial.
Article 11. For the electors of the liability regime provided for in this article, it shall be considered
object of compensation all the expenses derlvados of the impairment in the health of the subject submitted to
trial, as well as the economic damages that directly undermine such damage, provided that this is
consequence of submission to the clinical trial. It will not be subject to compensation under the
liability provided for in this article, the damage suffered by the subject subject to the trial in their health when
This is inhercnte to the pathology under study.
CHAPTER III. INFORMED CONSENT
Article 15. Informed consent process. The process for obtaining the informed consent of the
Participating in a clinical trial is achieved with the following actions:
1s. 1. Elaboration of an informed consent document with all the elements and requirements
established in the body of this provision.
1s. 2. Presentation of the content of the informed consent and procedure for its
Obtained before the Comilê de Ética en Investigación, for approval.
IN.3. Detailed explanation, in simple and understandable language for the subject or for Cu
legal representative, what is the research, what are the risks and benefits and what are
your rights to participate in the eCludio.
1g. 4. Discussion and answer to all the doubts and questions that the subject or his legal representative have.
1s. 5. . The participating subject or the legal representative, to give their consent to
To participate in the study, you must sign and date the document, together with the person who conducted the
information process ÿ explanation of the informed consent document.
1'i.6. If the subject to their legal representative cannot read or write, they must place their fingerprint. During
the entire process must be attended by an impartial witness, who must also sign or place his fingerprint
digital and date the document.
IN.7. Delivery of a signed copy of the approved informed consent document to Subject or to your
legal representative. •
15.8. File of the original of the informed consent document in the subject's clinical file.
Art (ass 16. The written informed consent document and any other written information that is
will provide subjects should be reviewed when new information emerges that may be relevant to
the subject's consent. Any form of written informed consent and written information
reviewed shall have the favorable approval of the Research Ethics Committee before
use. The subject or his legal representative must be informed in a timely manner if any
New information that may be relevant to your desire to continue participating in the study. The
Communication of the Information must be documented in the same way as the informed consent.
Article 17. Obtaining informed consent. The following requirements must be met:
17.1. The consent used in the investigation must have the formal approval of the Committee
of Élica en Invesligation before presenlarlo to the panicipants.
1z.z. The approved informed consent must be signed and signed by the president or coordinator of the
Comilé of Ethics in Research
accredited, or a member of the Comilê designated for that purpose, in accordance with its regulations, in each
one of its leaves and this one is the one that is presented to the subject.
at 1z. 3. Eslar written by Korma clear, without technicalities so that the subject
participant can understand it easily.
17.4. Have all its leaves foliated.
17.5. Indicate version number and date.
17.6. The paniclpanic subject in the investigation must give his consent before entering the study.
17.7. The subject must give their consent, free of coercion, with knowledge of all other
therapeutic options available.
17.s. The subject must know his right to change his mind and leave the study at any time
want.
17.s. Participant must receive a signed copy of the informed consent for their files
personal.
Article 18. Special regulations. Some situations, due to their characteristics, require an approach
In particular, for this, a special opinion given by "THE COMMITTEE Ô is required
18.1. Minors: In the case of minors, the person who
For example, its legal representation will be responsible for giving the contract and signing the document.
In extraordinary cases d = investigations without therapeutic purposes in minors, persons
disabled or with diminished competition or autonomy, the necessary measures will be taken to
avoid the possible exploitation of these dreams and the damage to their health. Minors who have the
adequate maturity or age, you must give your consent to participate in the study.
18.2. Subjects with mental disabilities. In the case of the incapable or in
status of a legal representative, must give consent and sign the report
on behalf of the participant, to whom the scope of the investigation must be explained, according to their
understanding capacity.
ISSUE 25
19.3.
jg g 1g.5.
CENTRAL AMERICA JOURNAL
If from the essay relevant knowledge about the
disease or cause of invasion. gives vital imoortancia to understand it. palliate it to cure it.
If these knowledge cannot be obtained in any other way.
If there are guarantees on the correct obtaining of informed consent, in accordance with the provisions of
this regulation.
Guatemolo, THURSDAY, February 22, 2007
25.10. Remuneration. It should be noted the expenses that patients received for expenses
transportation, allmenlación, and others, where appropriate. Likewise, in studies that do not
Therapeutic impact, amounts and how your participation will be rewarded.
25.11. Lions compensation. It must be clearly specified that the investigator will give medical care
the participant who suffers some
Article 20. Qualified emergencies: The following situations are considered:
The immediate use of the product under study is essential to preserve the life of a patient.
20.2. There is an inability to communicate with the patient, due to confusion, lethargy, coma, among olros.
20.3. There is no sufficient time to obtain the consent of an authorized legal representative.
A qualified physician, who has no participation in the study, should review and evaluate the
silutation. The Report completes the case, including the independent physician's report. it must be presented to
Research Ethics Committee for immediate review. It is imperative that the subject or his representative
be notified, \ an p £ o ¢ łlo as possible. to give the consent of
that the lralamîento be continued.
Article 21. Subjects who cannot read or write. Participation is essential in these houses
from an impartial witness during the study discussion. The consent of the subject can be expressed through the
printing of the fingerprint on the original document, after ensuring that the subject has understood
the content of the informed consent. It must also be accompanied by the fingerprint signature of the witness
impartial.
Article 22. Minors or disabled subjects, whose legal representative does not know how to read or
scrlblr. In these situations, the participation of a witness also applies, both during the
explanation of consent as during its signing.
Article 23. Prisoners. The deprivation of freedom can affect the ability of this group of individuals to take
a truly voluntary decision without coercion. For this reason, they are usually not included in studies.
clinicians and, when a subject participating in a study is incarcerated, they are excluded from the study if their condition
is not affected by this decision.
An exception to this general principle are some life and death situations, when the subject could
Benefit only from the treatment or when it comes to products that will be applied in the treatment
of prevailing conditions in prisoners.
A Committee on Ethics in Investigation that evaluates clinical studies on prisoners should take into account
Among its Members, at least one prisoner or a representative of them with experience and capacity to
I fulfilled] this function.
zs.1. Research Presentation. Indicating at least, title of the investigation, name of the
Researcher, telephone number and address where it will take place.
2s.z. Introduction. Indicating that it is an experimental study.
25.3. Purpose of the study. It must clearly indicate what will be the contributions that the study will reach
Level lenlïfico and the objective (s) of the study.
25.4. Procedures to senum.
study-related injury, without shifting that responsibility to health insurance or the
state health services. The sponsor will cover the treatment ribs that the patient
Anytime to recover from the injury, as long as the investigator adheres to protocol and Good Practice.
Clinical practices in conducting the clinical trial.
zs.1z. Confidentiality It must be specified that the confidentiality of the
Pan-municipal subjects will be preserved and that no subject will be identified by name in the
publication of the results of the study. Which regulatory authorities should be indicated. nationals remain
Aulorized to review their clinical record in order to see the results of the study. This same
Aulorization will apply to studio monitors, sponsor auditors and agency inspectors.
regulators and representatives of the Research Ethics Committee in charge of the study.
zs.13. Notification of new findings. The subject to their legal representative will be informed in due course of
any new discoveries that occurred during the study that could alert your decision to
I continue to participate in it.
25.IJ. Contacts. The name and telephone number of the entity (ies) must be indicated (including the
Research Ethics that approved the protocol) and person (s) to whom to turn to obtain
additional information about the study; and, in the eventual presentation of any injury attributable to t
Also, specify the name and telephone number of the main investigator to whom you will contact in case of emergency.
25.15. Voluntary participation: The absolutely voluntary nature of participation should be highlighted
of the subject, the option to withdraw at any time from the study without suffering any type of retaliation or
penalization for that act and the option of receiving alternative treatment, if you so desire.
zs.1ț. Completion of the study: The conditions or circumstances that could give must be specified
leading to premature termination of
study, such as the need for additional medication, violation of the study protocol,
the appearance of any study-related injury, the researcher said that, for
the good of the patient, is convenient, his retirement or for administrative reasons.
25.17. C onsentiment: A final paragraph should highlight that the participant has read and understood the document of the
consent. that your doubts have been clarified and all your questions answered to your satisfaction and that you accept
Voluntary participation in the study.
25.18. Names and signatures: The document is concluded with the names of the participating subject, the person who
explained consent and witness to witnesses; their signature, including their documents
personal identification, and the date the document was signed.
25.19. Exceptional houses: In case that due to the urgency of applying the treatment it was not possible to have the
consent of the subject to his legal representative at the time of inclusion in the clinical trial.
This fact will be reported to the Research Ethics Committee T at the sponsor of the researcher for its
supervision, explaining the reasons that have given rise to it. This situation must be foreseen in
the clinical trial protocol and informed consent approved by the corresponding Comitê de Élica in
Research and will only proceed when it has a particular therapeutic interest for the patient. The
Subject or his legal representative will be informed as soon as possible and will smell his condition for
continue in the trial if applicable.
to. The Iratamîenlo will receive and the possibility of allocation to each group of lralamienlo.
s The necessary procedures, especially all those that are invasive. Those highlighted
procedures to therapies that are experimental.
c. Description of the product to be used and its profile of adverse effects. It is customary to add a
general statement that "not all side effects of the product are known to date." When they are studies
Comparatives, a description of the comparator and its side effects should be included.
d. Responsibilities of the participating subject.
and. The approximate number of subjects and sites that will participate in the study should be noted.
The expected duration of the subject ‘participation in the study must also be specified.
25.5. Previous experience with the drug. The previous experimental experience should be indicated and
clinic with the product, and the result of these experiments.
z5.6. Annoyances and rieegoe. The inconveniences and risks that could be expected in the participants.
It should be noted that side effects may occur from discomfort that is not yet known.
25.7. Alternative therapies. Alternative therapeutic procedures that extend with
its potential risks and benefits.
z5.8. Exclusions. Conditions that impede your participation in the study, such as pregnancy, lactation,
allergies to certain products, and other circumstances.
25.9. Benefits. The benefits that the treatment could receive if it is effective. Must be
note that you may not receive any therapeutic benefit from your participation.
CHAPTER IV.
OF THE ETHICS COMMITTEES IN INVESTIGATION
Article 26. Accreditation of the Research Ethics Committees. They will be established based on t
recognition of the Department of Regulation and Control of Pharmaceutical and Related Products. which
The accreditation for the operation of the Research Ethics Committee that review and
clinical trials approved. THE COMMISSION will be in charge of the coordination and establishment
common criteria for the accreditation of the Committees. The accreditation of the Committee will be renewed
periodically according to the procedures and deadlines that it determines. which should not exceed a
two year period.
Article 27. Minimum requirements for accreditation of a Research Ethics Committee for review and
approval of clinical trial protocols. Be made up of a reasonable number of people who collectively
have the ability and experience to review and evaluate the science, medical aspects, and ethics of a CllniCo trial.
The Research Ethics Committees established under the administrative authority of an institution must
Have the approval of the Administration or the Direction of the same and explicit guarantee by the owner of the
Center, which guarantees that the Committee has the necessary means to carry out its mission.
The Committees established without being under the administrative authority of any ”institution. they should
demonstrate that they have the necessary resources to carry out their task.
Article 28. Integration of the Comlt ¢ de Étlca in Inx • estIgacIón. The Research Ethics Committee will be integrated
for a minimum of seven members, of which:
28.1. At least five members must have experience in ethics and research design.
1 4 Guotemolo, THURSDAY, February 22, 2007 CENTER DIARY
AMERICA
NUMBER
24.2. For our own sake one must be oblivious to the health profession
Article 33. General norms for the functioning of the Ethical Committees in
scientific community.
2e.8. At least one, must not be part of the clinical, public or private institution, at which time the
Committee.
28.4. In case of community trials, the Committee + must include an additional number of representatives of said
community for the duration of the
Investigation.
33.1. Its members will respect the principle of confidentiality. in regards to the documentation
received for the evaluation of the protocol and the identity of the participants and the discussions that take place within
of the Committee.
test.
33.2. For decisions u
oncrete are valid, it
z8.5. There must be gender representation among Comll + members.
28.6. The members of the Comiłês cannot have director or other financial interests with the
pharmaceutical industry or with entities contracted by it, which may affect the impartiality of
its functions.
28.7. For the above purposes, the Committee must keep a record of
permanent and updated interests based on a public declaration of interests, from each of the
members.
28.8. Any member with a special or particular interest in a proposal, direct or
hint; You should not take part in your evaluation if this interest could distort your judgment.
33.3. JJ4. 33.5.
The participation of at least five members is required, of which at least. one will be alien to the profession
sanitary.
When it is timely, it will seek the advice of expert persons not belonging to the Committee, who
respect the principle of confidentiality.
The principal investigator or collaborators of a clinical trial did not
They may participate neither in the evaluation nor in the opinion of their own protocol.
Establish a system that guarantees that the protocol approved by the
Research Ethics Committee, is identical to that sent to THE COMMISSION, and the same one that finally
will take place.
Article 29. Accreditation Procedure. The procedure consists of two stages:
z9.1. Evaluation of the documentation presented.
33.G. Establish a communication system with the investigators, which will
Let us know when a fatal to serious and unexpected adverse event has occurred.
33.7. ’Notify the periodicity of ordinary visits to the research site.
29.I. Local inspection.
The two stages will be evaluated by THE COMMISSION, who will issue and send its opinion to the Department of
Regulation and Control of Pharmaceutical and Related Products, for the issuance of the authorization.
If any non-compliance is detected, the recommendations will be delivered to the President or Coordinator of the Committee
written, which, once made and at the request of the interested parties, will be the subject of a new
evaluation for subsequent authorization, if applicable.
Article 30. Evaluation of the documentation presented. The documentation detailed below must
appear before THE COMMISSION:
33.8.
33.9.
Prepare and follow for its operation the standard operating procedures, mark a periodicity of
meeting and a maximum response time. These procedures must be public knowledge, upon request.
Of the interested.
Each meeting of the Committee will be included in the corresponding minutes. in which the members will be detailed
Attendees, it will be noted that for each study evaluated, the aspects have been weighted with
tempered in article 46 of this regulation, as well as information about the opinion and a summary of the
substantive elements of the discussion, explicit opinions about the reasons for which it was approved
whether or not a protocol is approved, which supports the decisions of the Committee.
30.1. Written request, signed and sealed by the Chairman of the Committee, addressed to THE COMMISSION.
in which the name, address and telephone number of the Research Ethics Committee are recorded.
30.2. For each of the members who will make up the Committee, the following must be attached
paper it:
to. Photocopy of the identity card.
b. Photocopy of the Curriculum Vİtae, specifying scientific activities performed and projection activities
Social.
c. Proof of active Collegiate in force when applicable.
d. Training in the subject of Research ethics.
and. Proof of participation in courses and other activities related to wind power in
investigation.
30.3. The Research Ethics Committees established under the administrative authority give a
Institution, whether public or public, must have proof of the address of the same.
30.4. Copy of the Regulations that will govern the operation of the Committee.
30.s. Minutes book or individual sheets, to be authorized and sealed by THE COMMISSION.
Article 31. Local inspection. The locative inspection will be carried out by THE COMMISSION in order to verify that
it has the necessary support infrastructure so that the Committee can function properly.
Article 32. Functions of the Research Ethics Committees. The responsibility of a Committee
at evaluating biomedical research, it is to contribute to safeguarding the dignity, rights, security and well-being
of all current and potential participants of the research; for this you must perform the
following functions:
32.1. Evaluate the adequacy of the protocol in relation to the objectives of the study. its efficiency
scientific, the possibility of reaching valid conclusions with the least possible exposlción of subjects and the
justification of the foreseeable risks and inconveniences, weighted according to the expected benefits
for subjects and society.
32.2. Assess the suitability of the research team for the proposed trial. It will take into account your experience and
investigative capacity to carry out the study, depending on their healthcare obligations and the
previously acquired commitments with other research protocols.
Evaluate the written information on the characteristics of the essay that
will give the possible subjects of the investigation, or failing that, their legal representative, the way
that said information will be provided and the type of informed consent that will
be obtained.
3t.4. Check the 'forecast of compensation and treatment to be offered to subjects
participants in case of injury or death attributable to the clinical trial, and compensation for
cover responsibilities.
32.5. They know and evaluate the scope of the compensations that will be offered to the subjects of the investigation for their
participation.
32.8. To approve the performance of the clinical trial before it is presented to THE COMMISSION.
32.7. Approve changes or amendments to the protocol to informed consent, before being
implemented.
32.8. Follow up on the clinical trial, from its start to receipt of the final report
of the researcher, through ordinary and extraordinary9 visits in accordance with the nature of the protocol and as
to define in its regulations. one'
32.9. Suspend general or permanently execute a protocol if serious abnormalities are detected.
violation of yourself. The researcher, the sponsor and LA CÇMISIÓŞ must be notified in writing of the
Committee's decision indicating the reasons for the suspension.
33.10. The Committee's opinions must be standardized in order to
support communication between the Committee and researchers from the AN rma:
evue \ to with racomenăaciones da oambios).
c. Recite d:.
33.11. The Committee must keep all relevant records for a period of three years after its conclusion.
the study and make them available at the request of the authority.
CHAPTER V
OF THE REQUIREMENTS OF CLINICAL TRIALS
Article 34. Requirements for conducting clinical trials. Pursuant to Articles 93 and 94 of the Agreement
Government 712-99, Regulation for the Sanitary Control of Medicines and Related Products, tests
Clinicians must submit to the authorization of the LA regulatory authority and evaluation.
COMMISSION. After the evaluation, yes. the regulatory authority shall grant the respective authorization.
Clinical trial procedures must have the review and approval of an Ethics Committee in
Research accredited by the Ministry of Health, through the respective agency.
Article 35. Application for authorization of a clinical trial. You must have the following documentation:
35.1. Request made by the researcher or sponsor, addressed to THE COMMISSION, indicating:
to. Protocol title and number.
b. Name and address of the principal investigator. c Research site.
d. Study drug (international code name, pharmaceutical form, concentration,
presentation).
and. Research phase.
1. Research Ethics Committee.
g. Sponsor.
h. Sub-investigators, when applicable.
‹Receipt of payment of the corresponding duty, according to the specific year.
35.2. Test protocol. clinical. Every protocol for the clinical trial shall be written in Spanish,
including the following basic sections:
to. Summary.
b. indice.
c. General information.
d. Justification and objectives.
and. Type of clinical test and its design.
F. Selection of subjects.
g. Description of thiaiamlento.
h. Development of the trial and evaluation of the response.
i. Adverse effects.
j. Informed consent and other applicable ethical aspects.
*. Practical considerations.
1. Statistical analysis.
35.a. Investigator's brochure, which may be in the original language with a summary in Spanish.
35.4. Procedure and model of the document to obtain consent
as.s. Investigator's commitment to comply with good Clinical and Informal Practices
periodically at the Research Ethics Committee from the beginning to the end of the research.
CENTER JOURNAL 25
AMERICA
Guatemala, THURSDAY, February 22, 2007
35.6. Written information to be provided to test subjects.
35.7. Approval report and follow-up of the trial by the Ethics Committee8 on Research duly
accredited as appropriate.
35.8. When appropriate, declaration of conformity of the relevant authorities of the center where
It will complete the test.
Article 36. Procedure. THE COMMISSION will communicate in writing to the Researcher, sponsor and Ethics Committee8
In Research, receipt of the application and complete documentation, as well as its subsequent authorization
express.
The following shall be subject to authorization: All clinical tests with a substance classified as a product in the
clinical research; search for new therapeutic indications of an already registered substance.
Article 37. Terms of authorization. During the first year of validity of this Agreement from
of its publication in the Diario de Centro America, THE COMMISSION will rule on a clinical study in a
no later than forty-five days after receipt of the request and complete documentation.
During the second year of validity and subject to the raising of private funds from THE COMMISSION,
This will have a term of thirty days. Within the aforementioned period, THE COMMISSION may request the information
pertinent, make objections, checks and corresponding observations.
In cases where additional information or clarifications are requested, once the new
information that the interested party has presented in his case, the final resolution will be found within a plaza of
15 days from the receipt of the required information. This resolution will be notified to the
Research Ethics, the researcher, the sponsor and any other party
Article 46. Evaluation criteria for the use of the dispute. The Êtlca Committee on Research
corresponding to evaluate the protocol, the investigator's brochure and the rest of the documentation that
Accompany the application and it will issue its opinion taking into consideration the following questions:
46.1. Relevance of the clinical trial. taking into account the available knowledge.
46.2. Relevance of your design to obtain informed conclusions with the appropriate number of
subjects in relation to the objective of the study.
46.3. Selection and withdrawal criteria for trial subjects, as well as the equitable selection of the
show.
46.4 .. Justification of the foreseeable costs and inconveniences in relation to the expected benefits for
the trial subjects, for other patients and for the community, taking into account the principle of
protection of the test subjects developed in the elic postulates.
46.5. Justification of the control group either placebo to an active treatment.
46.6. Provisions for monitoring the trial.
• s.7. Suitability of the researcher and his collaborators.
46.8. ldoneidad of the facilities.
46.9. Adequacy of written information for test subjects and the procedure for
oblenciôn informed consent. and justification of research in disabled people
to give your informed consent.
46.10. Financial guarantee insurance provided for the trial. 4s. 11. Remuneration forecasts, for the Subjects
of the essay.
46.12. Plan planned for the recruitment of the subjects.
interested. THE COMMISSION'S ACCLUTIONS MUST BE CONTAINED IN ADMINISTRATIVE RESOLUTIONS.
"” ”“ ’) Uend
be i et evaluated for each one be the Centers replicated n n s
Article 38. Conditions of Authorization. The authorization of a clinical trial is carried out for one year
and when necessary it must be renewed. For this, the researcher or sponsor must present a
request for renewal accompanied by progress reports of the clinical trial sent to the Ethics Committee in
Investigation for at least 30 days prior to the expiration of the current aulorization. THE COMMISSION respond
within 15 days of receiving the
Article 39. Modifications to the protocols of authorized clinical trials. C \ talquìe r modiflcation approved
The Research Ethics Committee shall be known to THE COMMISSION, and must be accompanied by
a summary of the proposed and approved modifications.
Any relevant modification that implies an increased risk for the participating subjects, must
be approved by the Research Ethics Committee and gUÎO ¢ i ¥ ãdâ ROI t_A COMMISSION.
Article 40. Expansion of the number of sites. Expanding the number of research sites initially
provided for in Guatemala must be approved by the Research Ethics Committee, which will not qualify LA
COMMISSION.
Article 41. Suspension of an authorized clinical trial. The performance of a clinical trial was
will suspend by justified petition of the investigator. from the sponsor, from the Ethics Committee8
Investigation or by decision of THE COMMISSION in the following cases:
41.1. For violation of these regulations.
41.z. Alteration of the conditions of your authorization.
41.3. Failure to comply with the ethical principles set forth in the regulations, to protect the subjects of the trial.
41.4. In defense of public health.
Article 42. Final report of the Investigator. Upon completion of the trial, the investigator or
The sponsor will send the final report to THE COMMISSION, taking responsibility with his signature for the veracity of the
data. In the event that the investigation does not come to an end, the researcher or sponsor will send
TO THE COMMISSION the Suspension Report and its reasons. Likewise, it will nolify the completion of the at trial
Research Ethics Committee.
Article 43. Importation of products for clinical trials. The authorization for the importation of
products to be used in clinical trials shall conform to the legal regulations applicable in each case and may be
granted in unit of act with the authorization of the clinical trial and its validity will be the
same. The sponsor must keep a record of imported products.
Article 44. Continuation of treatment after the end of the trial. Once the trial is over
clinical, the continuation of the administration of used products, should be governed by the rules
established for the compassionate uro, contained in the following article, as long as
authorized śu use for those conditions. This provision of medication for study subjects by a
Time to be agreed, may be requested from the sponsor, at the request of the Ethics Committee in
Research, the lnstilución where the study was carried out, THE COLLECTION and the researcher.
Article 47. Rules of good practice cllnlca. All clinical trials conducted in the country must
Carry out in accordance with internationally accepted standards of good clinical practice.
The Standards of Good Clinical Practice indicate the standards to be followed in designing, implementing and
communicate the results of the clinical tests, in order to ensure that the data is reliable and protected
the rights and integrity of the subjects. including the confidentiality of your data; Likewise,
The responsibilities of the different parties involved in each of the planning phases are indicated.
and execution of a clinical trial. They require the existence of pre-established procedures for
written, which must be applied systematically in the organization, direction, collection of
data, documentation and verification of clinical trials (Operation Standard Procedures).
It corresponds to the pairocinador established in the country, to sign the request for an opinion and authorization
addressed to the Research Ethics Committee and THE COMMUNITY.
In the event that the sponsor of the clinical study is not registered =. In the country. must present
proof that you are registered in the country of origin, complying with the law. In the case, you must
add to the documentation described in article 35 a copy of its most recent work report and the
names of its directors or board of directors.
The responsibilities of the sponsor or its representative are:
48.1. Establish and maintain a system of guarantees and quality control, with standardized procedures
of written works, so that the tests are carried out and the data generated is documented and
Communicated according to the protocol, the standards of good clinical practice and provided in this
normative.
48.2. Sign, together with the corresponding researcher, the protocol and any of its modifications.
4s. 3. Select the researcher and other personnel participating in the clinical trial more
appropriate according to their qualification and available means, and ensure that the latter will carry out the study as
as specified in the protocol.
4s. 4. Provide the basic and clinical information available on the product under investigation and update it to
throughout the trial.
48.5. Request the opinion of the Research Ethics Committee and the authorization of LA
COMMISSION, as well as supplying them with the information and obtaining the appropriate authorizations, in case of
modification or violation of the protocol or interruption of the trial, and the reasons for it.
48.6. SUPPLY GALLUALLY SUPPLY PRODUCTS IN INVEST'96 «ION, ENSURE THAT THE STANDARDS HAVE BEEN FULFILLED
of a correct claim and that they are adequately packaged and labeled. Also responsible
of the conservation of the product, its manufacturing and control protocols, registration of
quantities delivered and make sure that in the center where the test is carried out there is a procedure
correct handling, conservation and use of the same. Exceptionally, they can be agreed with the center
other ways of supply.
Article 45. Compassionate use of products. To use a product as compassionate use under
conditions of the original clinical trial, a use protocol drawn up by the doctor will be required
they request him; informed consent of the patient to his legal representative; clinical report in eJ that the doctor
justify the need for such treatment; when applicable, the .conformity of the director of the
the transfer is going to be administered; * ’and the aulorization of LA
4dL
48.8.
48.9.
Designate the monitor that will monitor the progress of the trial, when applicable. Communicate to THE COMMISSION, researchers and
Research Ethics Committees involved in the trial, suspected serious adverse reactions and
unexpected in accordance with to established in this normative.
Provide the staff of the clinical trial and Ethics Committee in
Investigation, immediately, of any information of importance to which you have access during the trial.
The responsible physician shall inform the COMMISSION of the results of the treatment, as well as the
suspicions of adverse reactions that may be due to it.
48.10. Provide financial compensation to subjects in the event of a death injury subject to the trial,
as long as the researcher adheres to the protocol and to the Good Clinical Practices in the conduct of the
clinical trial.
* Guatemala, THURSDAY, February 22, 2007
CEFJTRO AMERICA JOURNAL
ISSUE 25
48.11. Provide the investigator with legal and economic coverage in the event of one of the cases
described above, except if the injury is a consequence of neggligence or bad practice of the Investigator.
48.1z. Agree with the researcher on the distribution of responsibilities regarding data management,
preparation of reports and publication of results.
48.13. Ensure that the investigator provides subjects with more information about the trial.
48.14. Notify any change in the protocol, both to the Research Ethics Committee and to THE COMMISSION.
Article 49. Organixaclön de Investigación por Conțrato (OIC). A sponsor may transfer any or all
the tasks and functions related to studying an ICO, but the ultimate responsibility for quality and
Completeness of study data always rests with the sponsor. The ICO must implement
quality assurance and quality control. Any task and function related to the
Study that is transferred and assigned by an ICO must be specified in writing, in accordance with the
respective regulation.
Article 50. Monitor. The monitor's responsibilities are:
50.1. Work in accordance with the Standard Operating Procedures (PEO’s) of the
sponsor, visit the researcher before, during and after the trial to check the
protocol compliance. ensure that the data is recorded correctly and completes it in the bulletin
data collection. In this way, make sure that the informed behavior of all subjects has been reduced.
before inclusion in the trial.
Sü.2. Make sure that the researchers and the center where the research will be carried out are adequate
for this purpose during the test period.
so.a. Make sure that both the principal investigator and his collaborators have been adequately informed and
guarantee at all at least one
¢ Quick communication between invigator and sponsor.
5ü.4. , Verify that the investigator complies with the protocol and all its approved amendments.
so.5. Verify with respect to the products under investigation that the times and conditions of
They are acceptable and that supplies are sufficient during the study.
50.6. Verify that research products are supplied only to subjects who
they are eligible to receive it and at the doses specified in the protocol.
so.7. Verify that subjects are provided with the necessary instructions on the
proper use, handling, storage and return of research products.
50.8. Verify that the receipt, use and return of the products under investigation in the
The facilities where the study is carried out are procedures properly controlled and documented.
5ü.I. Verify that unused research products are destroyed or returned ă where applicable.
s0.10. Determine if all adverse events are reported appropriately within
the periods of time required by Good Clinical Practice. the protocol, the Committee of
Research Ethics and these regulations.
50.11. Submit to the sponsor reports of the monitoring visits and all IOș Contactor
relevant to the researcher, including their perception of the veracity of the information and the quality
of the work carried out by the researcher and his team.
Article 51. Investigator. The investigator directs and is responsible for the practical realization of the clinical trial
at a center, and sign the application together with the sponsor, sponsoring him. He can only act
as a researcher a doctor to a person who exercises a recognized profession in the country to carry out
the
. research based on his scientific training and his experience in health education
required.
In case said prolesional is not a doctor. A collegiate doctor in the country should be included as a sub-researcher.
The investigator's responsibilities are:
SI.1. Agree and sign the trial protocol with the sponsor.
The results or conclusions of the clinical tests will be reported prøțgrønlęmente in
scientific publications before being disclosed to non-health public. They will not be disclosed so
Premature or sensationalist traumatization of efficacy not yet determined, nor will it be exaggerated.
The advertising of investigational drugs is strictly prohibited, as established in the
regulation that regulates the advertising of medicines.
Article 53. Archive of the clinical trial documentation. The pat ^ oCiFìgłdOF 0 owner of the data of the
rehearsal is responsible for the archiving of the rehearsal documentation and shall retain all documentation relating to the
test, in accordance with its internal regulations. These documents will include:
sB.1. The protocol, including its justification, objectives, statistical design and
melodology of the test, with the conditions in which it is carried out and
manage, as well as the details of the research products used.
sa.z. Standard work procedures.
s8.3. All written reports on protocol and procedures. s3.4. Investigator's brochure,
s3.s. Data collection notebook for each subject.
s3.6. Final report.
53.7. -Audit certificate, when applicable.
Any change that occurs in the possession of your data will be documented. All data and documents are
will make available to the competent authorities in. cheers if they request it. In any case, it
ensure the confidentiality of the data and documents contained in the file.
Article 55. Inspections. THE COMMISSION will verify4 the application of the norm corresponding to the
monitoring compliance with the standards of good clinical practice, by means of inspections.
Inspections will be carried out in Cabo by duly qualified and appointed inspectors.
effect in places related to the conduct of clinical trials and, among others, in the center or
centers where the test is carried out, the place of manufacture of the medicine in
research, any analytical laboratory used in the clinical test and / or in the facilities
from the sponsor. After inspection, a report will be prepared and made available to the inspected,
of the Research Ethics Committee involved and the competent authorities in the country.
Article 56. Monitoring compliance with the rules of good clinical practice. THE COMMISSION may
carry out periodic inspections of any of the parties involved in the con ¢ iuction of a
clinical study, with the purpose of verifying compliance with Good Clinical Practice and
the corresponding Yes regŁilacio.
CHAPTER VI
OF THE SECURITY SURVEILLANCE OF MEDICINES IN INVESTIGATION
Article 57. Obligations of Investigators in the registry and communication of adverse events. The
The researcher will communicate within the first twenty-four hours, from the no recfication requested by
the sponsor, at Research Ethics Committee and THE COMMISSION, all serious adverse events, except
when dealing with those indicated in the protocol or in the investigator's brochure as events that do not require
Inmedlala communication. The initial communication will be followed by detailed written co-communications.
In the 'initial communications and in the follow-up communications, the subjects will be identified
51.2.
yes4
51.g.
51.7.
Request and obtain authorization for the clinical trial.
In-depth knowledge of the properties of the product under investigation, its protocol and procedures.
Ensure that informed consent is followed in accordance with the provisions of this regulation.
Collect, register and nolify IOS data for correct ›and guarantee its veracity.
Immediately report serious or unexpected enemas to the sponsor and to the Ethics Committee in
Investigation.
Ensuring that all the people involved respected the validity of any information
around the subjects of the trial, as well as the protection of their personal data.
of the clinical trial using a specific code number for each of them.
Adverse events and / or the results of abnormal work in the protocol qualified as
Determiners for safety evaluations will be communicated to the sponsor in accordance with the requirements of
communication and within the periods specified in the protocol.
In the event that a report has been reported from a subject participating in a clinical trial, the investigator
provide the sponsor and the Research Ethics Committees involved with all the relevant information
laria que sołicilen.
Article 58. Obligations of the person responsible for the clinical trial in the registry, evaluation and communication of
adverse enemas. The palrocinadqr manlendrã
51.0. Regularly informal at the March Research Ethics Committee
of the essay.
509. A ¢ Chiva £ and keep all documentation related to the study for a minimum of 2 years after
the approval of a commercialization request in the country and has passed at least 2
aO ^ iO5 de5from the formal suspension of the clinical development of the product under investigation.
Af‘ticuIA 52. Publish actions. Sponsor is obliged to disclose and publish the results
from clinical trials in scientific journals, both positive and negative.
..z
I '
When esududlos y lrabajos are released öe research on medicines, aimed at the community
scientific, the funds obtained by the author by a will be corrected for its realization and the source of
financing. The nonimatitude of the subjects participating in the trial will be maintained at all times.
Detailed records of all adverse events reported to you by the investigators. Is the
Registrations will be submitted to THE COMMISSION when requested to do so.
The sponsor has an obligation to continually evaluate the safety of medications in
research using all the information at your fingertips. Likewise, you must communicate without
delay to THE COMlSlÓhi, the competent bodies and the Ethics Committees in
Research involving any important information that affects the safety of the medicine in
investigation.
Said communication will be made according to the criteria specified in the following articles and
in accordance with the procedures established in the instructions for carrying out clinical tests
in the country.
The communication of the sponsor's security information to the investigators will be specified in the
standards of good clinical practice.
MINIG3’ERIO DE kA DEFENGA NACIONAc
MINISTERIAL AGREEMENT NUMBER 06-200 7