79C3C34C52B45572883A05D425EB0F82
Order No. 387 Relating to Clinical Trials
http://www.sante.dz/pharmacie-med/arr%C3%AAt%C3%A9_n%C2%B0387-388_31_juil_2006.pdf
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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 / political affiliation
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p.(None): imperatives of scientific rigor and safety of the people who lend themselves to this test;
p.(None): Article 11: Any serious effect likely to be due to research on a pharmaceutical product must be
p.(None): declared by the promoter, to the Minister of Health, Population and Hospital Reform,
p.(None): in accordance with the form attached in Annex D to this Order.
p.(None): Article 12: Minors and people admitted to a health or social establishment cannot be
p.(None): asked for a clinical trial only if we can expect a direct benefit for their health.
p.(None): Exceptionally pregnant and nursing mothers may be admitted to trials
p.(None): clinics if they do not face any foreseeable serious risk to their health or that of their child
p.(None): and that this research be useful for understanding the phenomena of pregnancy, childbirth or
p.(None): breastfeeding and if it cannot be done otherwise.
p.(None): Article 13: People who cannot take part in clinical trials are:
p.(None): - persons deprived of their liberty by a judicial or administrative decision;
p.(None): - patients in emergency situations and people hospitalized without consent.
p.(None): Article 14: For clinical trials without direct individual benefit, the sponsor assumes, even without
p.(None): fault, compensation for the harmful consequences of the test for the person who lends himself and that
p.(None): of his assigns, without being able to oppose the act of a third party or the voluntary withdrawal of the
p.(None): person who had initially agreed to participate in this test.
p.(None): For clinical trials with direct individual benefit, the sponsor assumes compensation for the consequences
p.(None): harmful to the test for the person who lends himself and that of his assigns, unless proven to his
p.(None): charges that the damage is not attributable to his fault or that of any intervener without that can be opposed
p.(None): made by a third party or the voluntary withdrawal of the person who originally consented to participate in the clinical trial.
p.(None): Article 15: The promoter is required to take out insurance guaranteeing his civil liability for the activity
p.(None): that he undertakes.
p.(None): Article 16: The clinical trial does not give rise to any direct or indirect financial compensation for
p.(None): persons who lend themselves to it, except reimbursement of expenses incurred by the person who
p.(None): ready for clinical trial.
p.(None): Article 17: The carrying out of any clinical trial is subject to a financial agreement between the promoter
p.(None): and the investigator.
p.(None): The promoter enters into a financial agreement with the establishment in the event that the clinical trial generates
p.(None): additional costs.
p.(None): Article 18: The financial means made available to the investigator must be invested, between
p.(None): another, for the acquisition of materials and equipment for the service where the clinical trial takes place.
p.(None): Article 19: The procedures determining the standards and methods applicable to the testing of products
p.(None): pharmaceuticals are set by order of the Minister of Health, Population and Hospital Reform.
p.(None): Article 20: Clinical trials must be carried out in accordance with the rules of good practice
p.(None): laboratory and rules of good clinical practice.
p.(None): Chapter 3: Consent of the person
p.(None): Article 21: Prior to carrying out a clinical trial on a person, free consent,
p.(None): informed and express of it must be collected after the investigator has made known to him:
p.(None): - the objective of the test, its methodology and its duration;
p.(None): - the expected benefits, the constraints and the foreseeable risks including in the event of the trial being stopped
p.(None): before its term.
p.(None): Article 22: The investigator must inform the person whose consent is sought of his right to
p.(None): refuse to participate in research or withdraw consent at any time without incurring any liability.
p.(None): Article 23: Consent is given in writing or, if this is not possible, it is certified by a third party. This
p.(None): the latter must be completely independent of the investigator and the promoter.
p.(None): Chapter 4: Protection of persons participating in clinical trials
p.(None): Article 24: Any clinical trial project must be submitted by the sponsor with the prior opinion of the ethics committee
p.(None): for clinical trials created in section 25 below.
p.(None): The ethics committee for clinical trials has one month from the date of receipt of the project
p.(None): to give his opinion.
p.(None): Article 25: The Minister of Health creates, in each health region, one or more committee (s)
p.(None): of ethics for clinical trials.
p.(None): The ethics committees for clinical trials have their seat in public health establishments.
p.(None): The organizational and operating procedures for ethics committees for clinical trials are set by
p.(None): instruction.
p.(None): Article 26: The ethics committee for clinical trials is an independent body, consisting of nine
p.(None): (09) people:
p.(None): - five (05) doctors including a general practitioner;
p.(None): - a pharmacist ;
p.(None): - a senior health technician;
p.(None): - a lawyer ;
p.(None): - a representative of patient associations.
p.(None): The ethics committee for clinical trials may call on any person likely to help it in
p.(None): his works.
...
p.(None): protocol. Information may be collected by any means ensuring the editing and
p.(None): conservation, and allowing quality control.
p.(None): Confidentiality:
p.(None): The medical professional secrecy rule applies to everyone who participates directly (investigating doctor)
p.(None): or indirectly (ARC, monitors, quality controllers) to clinical research.
p.(None): Informed consent:
p.(None): Free and formally expressed acceptance of a person to participate in research
p.(None): clinical. Consent is said to be "informed" when the person has received it from the doctor
p.(None): investigator (or a substitute doctor) all information regarding: the objectives of the trial, the
p.(None): benefits, risks and constraints.
p.(None): The person's consent can be withdrawn at any time without prejudice to themselves.
p.(None): Consent is evidenced by the person signing a "
p.(None): consent "meaning that she received all the information she wanted regarding the test
p.(None): clinical.
p.(None): Financial agreement
p.(None): Contract governing the rights and financial responsibilities of people involved in clinical research.
p.(None): Test protocol
p.(None): Text bringing together all the descriptive elements of clinical research and which specifies the conditions in
p.(None): which this research must be carried out and managed.
p.(None): Additional research costs
p.(None): This term defines the cost of research which, in a patient included in a clinical trial, cannot be charged to the
p.(None): hospital budget but which must be paid for either by the trial sponsor or by a third party
p.(None): which funds research. This cost of research will be very clearly differentiated from the cost of care that the
p.(None): Anyway, the patient would have received if he had not been included in this research.
p.(None): Standard operating procedures
p.(None): A standard operating procedure (POS) presents in writing the details of the actions to be performed during a measurement
p.(None): to be made or a decision to be made in a research protocol.
p.(None): The advantage of a standard operating procedure is that it encourages all investigators to work from
p.(None): the same way and that it saves them from unfortunate omissions. All kinds of POS can be written in the
p.(None): clinical research concerning the responsibilities of the promoter, ARCs, investigators,
p.(None): auditors and inspectors. SOPs must be regularly updated, dated and signed by the person
p.(None): responsible for their writing.
p.(None): APPENDIX B
p.(None): DECLARATION OF INTENT TO TEST A PHARMACEUTICAL PRODUCT
p.(None): Date of declaration / / /
p.(None): 1. Promoter (name or Registration by administration
p.(None): name and address) Number:
p.(None): Date: / / / Stamp
p.(None): 2. Title of the essay:
p.(None): 3. Objective:
p.(None): 4. Research with direct individual benefit: yes no
p.(None): 5. Clinical experimentation phase (I, IIa, IIb, III, IV):
p.(None): 6. Test:
p.(None): controlled: multicentric: international:
p.(None): randomized: single blind: double blind:
p.(None): crossed: parallel groups: open: other, to be specified:
p.(None): 7. Observational study: / /
p.(None): Pharmacovigilance / / Prevalence / / Pharmacoepidemiology
p.(None): / / Pharmaco economics / / Cohort / /
p.(None): Case-witnesses / / other, to be specified:
...
Health / Drug Usage
Searching for indicator drug:
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p.(None): People's Democratic Republic of Algeria Ministry of Population Health and Hospital Reform
p.(None): Order n ° 387 of July 31, 2006 relating to clinical trials
p.(None): The Minister of Health, Population and Hospital Reform;
p.(None): - Having regard to Law No. 85-05 of February 16, 1985, amended and supplemented, relating to the protection and promotion of
p.(None): health, in particular Articles 178, 168/2, 168/3 and 168/4;
p.(None): - Having regard to Ordinance No. 95-07 of 23 Châabane 1415 corresponding to January 25, 1995 relating to insurance;
p.(None): - Having regard to Executive Decree No. 93-53 of June 28, 1993, creating the official bulletin of the Ministry of
p.(None): health and population;
p.(None): - Having regard to Executive Decree No. 96-66 of 7 Ramadhan 1416 corresponding to January 27, 1996, fixing the attributions of the
p.(None): Minister of Health and Population;
p.(None): - In view of Executive Decree No. 05-428 of 5 Choual 1426 corresponding to November 7, 2005 on the organization of
p.(None): the administration of the Ministry of Health, Population and Hospital Reform;
p.(None): - Given Presidential Decree No. 06-176 of 27 Rabie Ethani 1427 corresponding to May 25, 2006
p.(None): appointing members of the Government;
p.(None): - Having regard to Order No. 112 / MSP / MIN of October 22, 1995 establishing good clinical practice;
p.(None): - Considering the decree n ° 44 of September 21, 1998 bearing form of declaration of intention for
p.(None): testing a drug or similar product.
p.(None): - Considering the decree n ° 48 of October 7, 1998 relating to the form for declaration of a serious effect likely to be due to
p.(None): biomedical research on a drug or pharmaceutical product;
p.(None): - Considering the decree n ° 67 of December 06, 1998 establishing the clinical trials unit.
p.(None): Stopped
p.(None): Chapter 1: Purpose - definitions
p.(None): Article 1: The purpose of this decree is to define the conditions under which the
p.(None): human clinical trials.
p.(None): Article 2: Clinical trial means any investigation carried out on human subjects with a view to
p.(None): discover or verify clinical and pharmacological effects of a pharmaceutical product, identify
p.(None): any adverse reactions in order to assess their efficacy and safety.
p.(None): The clinical trial includes:
p.(None): - therapeutic, diagnostic and preventive trials;
p.(None): - observational studies;
p.(None): - bioequivalence studies.
p.(None): Article 3: A clinical trial is said:
p.(None): - with direct individual benefit (BID) when the patients included in the trial benefit directly
p.(None): of a possible therapeutic benefit for the management of their pathology.
p.(None): - Without direct individual benefit (SBID) when the healthy subjects included in the test derive no benefit
p.(None): direct therapy.
p.(None): Article 4: Clinical trials require promoters, and / or research organizations called
p.(None): contract research organization (CRO) and investigators.
p.(None): Article 5: By promoter is meant any natural or legal person who takes the initiative in a clinical trial.
p.(None): “Contract research organization” (CRO) means any service provider in the field
p.(None): clinical trials. This company is assimilated to a promoter.
p.(None): By investigator is meant any general practitioner or specialist who directs and monitors the performance of the trial
p.(None): clinical.
p.(None): Article 6: The terms and concepts commonly used in the field of clinical trials are defined in the
p.(None): glossary attached in appendix A to this decree
p.(None): Chapter 2: general provisions
...
p.(None): the test and the results obtained.
p.(None): Article 13: The carrying out of a bioequivalence or bioavailability study is subject
p.(None): the same procedure as the clinical trial.
p.(None): Article 14: For the realization of an observational study, the promoter must only deposit at the level of the
p.(None): Department of Pharmacy of the Ministry of Health, Population and Reform
p.(None): hospital, the clinical trial protocol and the declaration of intent form
p.(None): clinical trial established for this purpose.
p.(None): Article 15: This decree is published in the official bulletin of the Ministry of Health, Population and
p.(None): hospital reform.
p.(None): ANNEX A
p.(None): Glossary
p.(None): Amendment
p.(None): Text amending a provision of a clinical research protocol already approved by an ethics committee.
p.(None): The principal investigator of the trial sends the amendment to the ethics committee.
p.(None): Two possibilities :
p.(None): - the amendment does not significantly change the protocol. In this case, the ethics committee is informed but does not give
p.(None): no opinion ;
p.(None): - the amendment profoundly modifies the protocol and the possible risks for patients. In this case, the committee
p.(None): of ethics deliberates and must give an opinion (favorable or not) on the amendment.
p.(None): AMM (Marketing Authorization)
p.(None): Administrative authorization issued by the Director of Pharmacy and Equipment to
p.(None): the pharmaceutical establishment which wishes to put a drug on the Algerian market. The director
p.(None): of Pharmacy and Equipment makes its decision following the advice of the committee of experts
p.(None): clinicians.
p.(None): archiving
p.(None): All clinical trial documents must be kept for 15 years after the end of the trial,
p.(None): both by the investigators and by the sponsor.
p.(None): Quality assurance
p.(None): System set up to ensure the quality of a clinical trial, the reliability of its results and compliance with
p.(None): ethics and law during the essay. It includes :
p.(None): - the quality controls carried out by the clinical research assistant
p.(None): - the audit
p.(None): - the inspection carried out by the competent administrative authorities
p.(None): Audit
p.(None): Analysis procedure of a clinical trial, carried out by an independent auditor of the trial and mandated by the
p.(None): promoter in order to ensure the quality of the test, the reliability of its results and respect
p.(None): during the test of the ethics, the law and the regulations in force. The audit report is the property of
p.(None): promoter who carried out the financial burden of the audit.
p.(None): Direct individual benefit (BID)
p.(None): Clinical research is said to have direct individual benefit when patients included in the trial
p.(None): will directly benefit from a possible therapeutic benefit for the management of their pathology.
p.(None): Conversely, any other clinical research is said to have no direct individual benefit when the subjects
p.(None): healthy or the patients included in the trial do not shoot
p.(None): no direct therapeutic benefit from the research in which they agreed to participate.
p.(None): Good Clinical Practice (GCP)
p.(None): Set of provisions which guarantee the quality and authenticity of information in clinical research
p.(None): collected and compliance with the law and regulations guaranteeing the rights of people in research
p.(None): clinical.
p.(None): bioavailability
p.(None): Study of the speed and the rate of release of the active principle of a pharmaceutical preparation, determined by
p.(None): its concentration curve in general circulation as a function of time or by its excretion
p.(None): in the urine.
p.(None): bioequivalence
p.(None): Two drugs are bioequivalent if they are pharmaceutically equivalent and if their bioavailability
p.(None): (rate and release rate), after administration of the same molar dose, is close enough that one can
p.(None): can expect essentially the same effects.
p.(None): Investigator's brochure:
p.(None): Refers to the comprehensive set of information collected at a given time on a drug, at the development stage
p.(None): where it is before the AMM. The investigator's brochure must be given before the start of a trial
p.(None): clinical to any investigator participating in this trial.
p.(None): The trial sponsor is responsible for writing and regularly updating the brochure (dated, signed).
p.(None): Observation book:
p.(None): Document intended to collect as the test progresses, for each subject, the information defined by the
p.(None): protocol. Information may be collected by any means ensuring the editing and
p.(None): conservation, and allowing quality control.
p.(None): Confidentiality:
p.(None): The medical professional secrecy rule applies to everyone who participates directly (investigating doctor)
p.(None): or indirectly (ARC, monitors, quality controllers) to clinical research.
p.(None): Informed consent:
p.(None): Free and formally expressed acceptance of a person to participate in research
p.(None): clinical. Consent is said to be "informed" when the person has received it from the doctor
p.(None): investigator (or a substitute doctor) all information regarding: the objectives of the trial, the
p.(None): benefits, risks and constraints.
p.(None): The person's consent can be withdrawn at any time without prejudice to themselves.
p.(None): Consent is evidenced by the person signing a "
p.(None): consent "meaning that she received all the information she wanted regarding the test
p.(None): clinical.
p.(None): Financial agreement
p.(None): Contract governing the rights and financial responsibilities of people involved in clinical research.
p.(None): Test protocol
...
p.(None): 21. Scientific name and INN of the active principle (s):
p.(None): 22. Pharmaceutical form (pharmacopoeia):
p.(None): 23. Qualitative and quantitative composition of active ingredients (using common names
p.(None): international):
p.(None): 24. Dosage:
p.(None): 25. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): PLACEBO
p.(None): 26. Pharmaceutical form (pharmacopoeia):
p.(None): 27. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): INVESTIGATIVE (S)
p.(None): 28. Last name (s) and First name (s)
p.(None): 31. Quality
p.(None): 32. Place of performance
p.(None): PEOPLE LOOKING FOR RESEARCH
p.(None): 29. Expected number of people:
p.(None): 30. Therapeutic indication:
p.(None): 31. Main inclusion criteria:
p.(None): 32. Duration of treatment or participation per person:
p.(None): ETHICS COMMITTEE
p.(None): 33. Committee (name and address:
p.(None): 34. Favorable opinion Unfavorable opinion
p.(None): 35. Date of notice:
p.(None): INSURANCE
p.(None): 36. Insurance company (name or name):
p.(None): 37. Number of contract signed:
p.(None): Send 3 copies of this declaration to the DPHM
p.(None): APPENDIX D
p.(None): DATASHEET OF A SERIOUS ADVERSE EVENT
p.(None): STUDY :
p.(None): PROTOCOL:
p.(None): 1. INFORMATION ABOUT THE PATIENT:
p.(None): Last name First Name :
p.(None): Patient number
p.(None): Gender: F M
p.(None): Date of Birth :
p.(None): Weight height :
p.(None): 2. DECLARING
p.(None): Promoter:
p.(None): Name: Position:
p.(None): Telephone: Fax:
p.(None): Investigator:
p.(None): Test center:
p.(None): Name: Position:
p.(None): Telephone: Fax:
p.(None): 3 ADMISSIBLE DRUGS
p.(None): Drug (s
p.(None): ) of the study
p.(None): way
p.(None): Dose
p.(None): Dated
p.(None): From start to stop
p.(None): Reason for prescription
p.(None): Drug (s
p.(None): ) associated
p.(None): way
p.(None): Dose
p.(None): Dated
p.(None): From start to stop
p.(None): Reason for prescription
p.(None): 4. DESCRIPTION OF THE EVENT
p.(None): (clinical and paraclinical signs)
p.(None): Date of occurrence (day, month, year): / / / / / / / / / /
p.(None): Delay after the last dose (day, hour, minute): / / / / / / / / / /
p.(None): Evolution: - Spontaneous regression yes no
p.(None): - Regression under treatment yes no
p.(None): Corrector: - Persistence: yes no - Worsening: yes no
p.(None): Accountability: - Excluded: yes no - Possible: yes no
p.(None): - Likely: yes no - Very likely: yes no
p.(None): Taken measures :
p.(None): Any
p.(None): Corrective treatment
p.(None): Stopping the suspected drug
p.(None): Re-administration of the suspected product: YES NO Recurrence of the event:
p.(None): YES NO
p.(None): 5. COMMENTS
p.(None): Date Stamp Signature of the declarant:
p.(None): APPENDIX C
p.(None): NATIONAL REGISTER OF CLINICAL TRIALS
p.(None): N ° Date of
p.(None): deposit
p.(None): Promoter / Trial Monitor
p.(None): Principal investigator
p.(None): Test product
p.(None): Essay title
p.(None): Date of authorization
p.(None): Type of test (phase)
p.(None): Results reporting
...
Health / Pregnant
Searching for indicator pregnant:
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p.(None): health, population and hospital reform.
p.(None): Article 8: Any sponsor of a clinical trial on human beings must declare their intention to carry out the latter, at
p.(None): Minister of Health, Population and Hospital Reform, who issues an authorization to this effect.
p.(None): The declaration of intent is made in accordance with the form attached in Annex B to this Order.
p.(None): The Minister of Health, Population and Hospital Reform may, at any time, ask the promoter for
p.(None): additional information about the clinical trial. He can also, at any time, suspend or prohibit a trial
p.(None): clinical.
p.(None): Article 9: No clinical trial can be carried out on humans:
p.(None): - if it is not based on the latest state of clinical research, scientific knowledge
p.(None): and on sufficient pre-clinical experimentation;
p.(None): - if the foreseeable benefit / risk ratio is not for the benefit of the subject included in the research.
p.(None): Article 10: Clinical trials can only be carried out:
p.(None): - under the direction and under the supervision of a doctor who can demonstrate appropriate experience;
p.(None): - under material and technical conditions adapted to the clinical trial and compatible with
p.(None): imperatives of scientific rigor and safety of the people who lend themselves to this test;
p.(None): Article 11: Any serious effect likely to be due to research on a pharmaceutical product must be
p.(None): declared by the promoter, to the Minister of Health, Population and Hospital Reform,
p.(None): in accordance with the form attached in Annex D to this Order.
p.(None): Article 12: Minors and people admitted to a health or social establishment cannot be
p.(None): asked for a clinical trial only if we can expect a direct benefit for their health.
p.(None): Exceptionally pregnant and nursing mothers may be admitted to trials
p.(None): clinics if they do not face any foreseeable serious risk to their health or that of their child
p.(None): and that this research be useful for understanding the phenomena of pregnancy, childbirth or
p.(None): breastfeeding and if it cannot be done otherwise.
p.(None): Article 13: People who cannot take part in clinical trials are:
p.(None): - persons deprived of their liberty by a judicial or administrative decision;
p.(None): - patients in emergency situations and people hospitalized without consent.
p.(None): Article 14: For clinical trials without direct individual benefit, the sponsor assumes, even without
p.(None): fault, compensation for the harmful consequences of the test for the person who lends himself and that
p.(None): of his assigns, without being able to oppose the act of a third party or the voluntary withdrawal of the
p.(None): person who had initially agreed to participate in this test.
p.(None): For clinical trials with direct individual benefit, the sponsor assumes compensation for the consequences
p.(None): harmful to the test for the person who lends himself and that of his assigns, unless proven to his
p.(None): charges that the damage is not attributable to his fault or that of any intervener without that can be opposed
p.(None): made by a third party or the voluntary withdrawal of the person who originally consented to participate in the clinical trial.
...
Health / hospitalized patients
Searching for indicator hospitalized:
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p.(None): - if the foreseeable benefit / risk ratio is not for the benefit of the subject included in the research.
p.(None): Article 10: Clinical trials can only be carried out:
p.(None): - under the direction and under the supervision of a doctor who can demonstrate appropriate experience;
p.(None): - under material and technical conditions adapted to the clinical trial and compatible with
p.(None): imperatives of scientific rigor and safety of the people who lend themselves to this test;
p.(None): Article 11: Any serious effect likely to be due to research on a pharmaceutical product must be
p.(None): declared by the promoter, to the Minister of Health, Population and Hospital Reform,
p.(None): in accordance with the form attached in Annex D to this Order.
p.(None): Article 12: Minors and people admitted to a health or social establishment cannot be
p.(None): asked for a clinical trial only if we can expect a direct benefit for their health.
p.(None): Exceptionally pregnant and nursing mothers may be admitted to trials
p.(None): clinics if they do not face any foreseeable serious risk to their health or that of their child
p.(None): and that this research be useful for understanding the phenomena of pregnancy, childbirth or
p.(None): breastfeeding and if it cannot be done otherwise.
p.(None): Article 13: People who cannot take part in clinical trials are:
p.(None): - persons deprived of their liberty by a judicial or administrative decision;
p.(None): - patients in emergency situations and people hospitalized without consent.
p.(None): Article 14: For clinical trials without direct individual benefit, the sponsor assumes, even without
p.(None): fault, compensation for the harmful consequences of the test for the person who lends himself and that
p.(None): of his assigns, without being able to oppose the act of a third party or the voluntary withdrawal of the
p.(None): person who had initially agreed to participate in this test.
p.(None): For clinical trials with direct individual benefit, the sponsor assumes compensation for the consequences
p.(None): harmful to the test for the person who lends himself and that of his assigns, unless proven to his
p.(None): charges that the damage is not attributable to his fault or that of any intervener without that can be opposed
p.(None): made by a third party or the voluntary withdrawal of the person who originally consented to participate in the clinical trial.
p.(None): Article 15: The promoter is required to take out insurance guaranteeing his civil liability for the activity
p.(None): that he undertakes.
p.(None): Article 16: The clinical trial does not give rise to any direct or indirect financial compensation for
p.(None): persons who lend themselves to it, except reimbursement of expenses incurred by the person who
p.(None): ready for clinical trial.
p.(None): Article 17: The carrying out of any clinical trial is subject to a financial agreement between the promoter
p.(None): and the investigator.
p.(None): The promoter enters into a financial agreement with the establishment in the event that the clinical trial generates
p.(None): additional costs.
p.(None): Article 18: The financial means made available to the investigator must be invested, between
...
Health / visual impairment
Searching for indicator blind:
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p.(None): Additional research costs
p.(None): This term defines the cost of research which, in a patient included in a clinical trial, cannot be charged to the
p.(None): hospital budget but which must be paid for either by the trial sponsor or by a third party
p.(None): which funds research. This cost of research will be very clearly differentiated from the cost of care that the
p.(None): Anyway, the patient would have received if he had not been included in this research.
p.(None): Standard operating procedures
p.(None): A standard operating procedure (POS) presents in writing the details of the actions to be performed during a measurement
p.(None): to be made or a decision to be made in a research protocol.
p.(None): The advantage of a standard operating procedure is that it encourages all investigators to work from
p.(None): the same way and that it saves them from unfortunate omissions. All kinds of POS can be written in the
p.(None): clinical research concerning the responsibilities of the promoter, ARCs, investigators,
p.(None): auditors and inspectors. SOPs must be regularly updated, dated and signed by the person
p.(None): responsible for their writing.
p.(None): APPENDIX B
p.(None): DECLARATION OF INTENT TO TEST A PHARMACEUTICAL PRODUCT
p.(None): Date of declaration / / /
p.(None): 1. Promoter (name or Registration by administration
p.(None): name and address) Number:
p.(None): Date: / / / Stamp
p.(None): 2. Title of the essay:
p.(None): 3. Objective:
p.(None): 4. Research with direct individual benefit: yes no
p.(None): 5. Clinical experimentation phase (I, IIa, IIb, III, IV):
p.(None): 6. Test:
p.(None): controlled: multicentric: international:
p.(None): randomized: single blind: double blind:
p.(None): crossed: parallel groups: open: other, to be specified:
p.(None): 7. Observational study: / /
p.(None): Pharmacovigilance / / Prevalence / / Pharmacoepidemiology
p.(None): / / Pharmaco economics / / Cohort / /
p.(None): Case-witnesses / / other, to be specified:
p.(None): 8. Bioequivalence study: / /
p.(None): 9. Scheduled date for the start of the search: / / /
p.(None): 10. Expected duration:
p.(None): MEDICINE OR STUDY PRODUCT
p.(None): (If the trial involves several drugs or products, use one page for each of them)
p.(None): 11. Special name:
p.(None): 12. Code name:
p.(None): 13. Scientific name and D.C.I of the active principle (s):
p.(None): 14. Pharmaceutical form (pharmacopoeia):
p.(None): 15. Qualitative and quantitative composition (using international non-proprietary names):
p.(None): 16. New active ingredient: yes no
p.(None): 17. Dosage:
p.(None): 18. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): 19. D. E or A.M.M:
p.(None): - Algeria: yes no refusal suspension withdrawal
p.(None): - Abroad (name the main countries):
p.(None): REFERENCE MEDICINAL PRODUCT
p.(None): 20. Special name:
p.(None): 21. Scientific name and INN of the active principle (s):
p.(None): 22. Pharmaceutical form (pharmacopoeia):
p.(None): 23. Qualitative and quantitative composition of active ingredients (using common names
p.(None): international):
p.(None): 24. Dosage:
p.(None): 25. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): PLACEBO
p.(None): 26. Pharmaceutical form (pharmacopoeia):
p.(None): 27. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): INVESTIGATIVE (S)
p.(None): 28. Last name (s) and First name (s)
p.(None): 31. Quality
p.(None): 32. Place of performance
p.(None): PEOPLE LOOKING FOR RESEARCH
p.(None): 29. Expected number of people:
p.(None): 30. Therapeutic indication:
...
Social / Incarcerated
Searching for indicator liberty:
(return to top)
p.(None): clinical.
p.(None): Article 9: No clinical trial can be carried out on humans:
p.(None): - if it is not based on the latest state of clinical research, scientific knowledge
p.(None): and on sufficient pre-clinical experimentation;
p.(None): - if the foreseeable benefit / risk ratio is not for the benefit of the subject included in the research.
p.(None): Article 10: Clinical trials can only be carried out:
p.(None): - under the direction and under the supervision of a doctor who can demonstrate appropriate experience;
p.(None): - under material and technical conditions adapted to the clinical trial and compatible with
p.(None): imperatives of scientific rigor and safety of the people who lend themselves to this test;
p.(None): Article 11: Any serious effect likely to be due to research on a pharmaceutical product must be
p.(None): declared by the promoter, to the Minister of Health, Population and Hospital Reform,
p.(None): in accordance with the form attached in Annex D to this Order.
p.(None): Article 12: Minors and people admitted to a health or social establishment cannot be
p.(None): asked for a clinical trial only if we can expect a direct benefit for their health.
p.(None): Exceptionally pregnant and nursing mothers may be admitted to trials
p.(None): clinics if they do not face any foreseeable serious risk to their health or that of their child
p.(None): and that this research be useful for understanding the phenomena of pregnancy, childbirth or
p.(None): breastfeeding and if it cannot be done otherwise.
p.(None): Article 13: People who cannot take part in clinical trials are:
p.(None): - persons deprived of their liberty by a judicial or administrative decision;
p.(None): - patients in emergency situations and people hospitalized without consent.
p.(None): Article 14: For clinical trials without direct individual benefit, the sponsor assumes, even without
p.(None): fault, compensation for the harmful consequences of the test for the person who lends himself and that
p.(None): of his assigns, without being able to oppose the act of a third party or the voluntary withdrawal of the
p.(None): person who had initially agreed to participate in this test.
p.(None): For clinical trials with direct individual benefit, the sponsor assumes compensation for the consequences
p.(None): harmful to the test for the person who lends himself and that of his assigns, unless proven to his
p.(None): charges that the damage is not attributable to his fault or that of any intervener without that can be opposed
p.(None): made by a third party or the voluntary withdrawal of the person who originally consented to participate in the clinical trial.
p.(None): Article 15: The promoter is required to take out insurance guaranteeing his civil liability for the activity
p.(None): that he undertakes.
p.(None): Article 16: The clinical trial does not give rise to any direct or indirect financial compensation for
p.(None): persons who lend themselves to it, except reimbursement of expenses incurred by the person who
p.(None): ready for clinical trial.
p.(None): Article 17: The carrying out of any clinical trial is subject to a financial agreement between the promoter
p.(None): and the investigator.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): which this research must be carried out and managed.
p.(None): Additional research costs
p.(None): This term defines the cost of research which, in a patient included in a clinical trial, cannot be charged to the
p.(None): hospital budget but which must be paid for either by the trial sponsor or by a third party
p.(None): which funds research. This cost of research will be very clearly differentiated from the cost of care that the
p.(None): Anyway, the patient would have received if he had not been included in this research.
p.(None): Standard operating procedures
p.(None): A standard operating procedure (POS) presents in writing the details of the actions to be performed during a measurement
p.(None): to be made or a decision to be made in a research protocol.
p.(None): The advantage of a standard operating procedure is that it encourages all investigators to work from
p.(None): the same way and that it saves them from unfortunate omissions. All kinds of POS can be written in the
p.(None): clinical research concerning the responsibilities of the promoter, ARCs, investigators,
p.(None): auditors and inspectors. SOPs must be regularly updated, dated and signed by the person
p.(None): responsible for their writing.
p.(None): APPENDIX B
p.(None): DECLARATION OF INTENT TO TEST A PHARMACEUTICAL PRODUCT
p.(None): Date of declaration / / /
p.(None): 1. Promoter (name or Registration by administration
p.(None): name and address) Number:
p.(None): Date: / / / Stamp
p.(None): 2. Title of the essay:
p.(None): 3. Objective:
p.(None): 4. Research with direct individual benefit: yes no
p.(None): 5. Clinical experimentation phase (I, IIa, IIb, III, IV):
p.(None): 6. Test:
p.(None): controlled: multicentric: international:
p.(None): randomized: single blind: double blind:
p.(None): crossed: parallel groups: open: other, to be specified:
p.(None): 7. Observational study: / /
p.(None): Pharmacovigilance / / Prevalence / / Pharmacoepidemiology
p.(None): / / Pharmaco economics / / Cohort / /
p.(None): Case-witnesses / / other, to be specified:
p.(None): 8. Bioequivalence study: / /
p.(None): 9. Scheduled date for the start of the search: / / /
p.(None): 10. Expected duration:
p.(None): MEDICINE OR STUDY PRODUCT
p.(None): (If the trial involves several drugs or products, use one page for each of them)
p.(None): 11. Special name:
p.(None): 12. Code name:
p.(None): 13. Scientific name and D.C.I of the active principle (s):
p.(None): 14. Pharmaceutical form (pharmacopoeia):
p.(None): 15. Qualitative and quantitative composition (using international non-proprietary names):
p.(None): 16. New active ingredient: yes no
p.(None): 17. Dosage:
p.(None): 18. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): 19. D. E or A.M.M:
p.(None): - Algeria: yes no refusal suspension withdrawal
p.(None): - Abroad (name the main countries):
p.(None): REFERENCE MEDICINAL PRODUCT
p.(None): 20. Special name:
p.(None): 21. Scientific name and INN of the active principle (s):
p.(None): 22. Pharmaceutical form (pharmacopoeia):
p.(None): 23. Qualitative and quantitative composition of active ingredients (using common names
p.(None): international):
p.(None): 24. Dosage:
p.(None): 25. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): PLACEBO
p.(None): 26. Pharmaceutical form (pharmacopoeia):
p.(None): 27. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): INVESTIGATIVE (S)
p.(None): 28. Last name (s) and First name (s)
p.(None): 31. Quality
p.(None): 32. Place of performance
...
Social / Mothers
Searching for indicator mothers:
(return to top)
p.(None): Minister of Health, Population and Hospital Reform, who issues an authorization to this effect.
p.(None): The declaration of intent is made in accordance with the form attached in Annex B to this Order.
p.(None): The Minister of Health, Population and Hospital Reform may, at any time, ask the promoter for
p.(None): additional information about the clinical trial. He can also, at any time, suspend or prohibit a trial
p.(None): clinical.
p.(None): Article 9: No clinical trial can be carried out on humans:
p.(None): - if it is not based on the latest state of clinical research, scientific knowledge
p.(None): and on sufficient pre-clinical experimentation;
p.(None): - if the foreseeable benefit / risk ratio is not for the benefit of the subject included in the research.
p.(None): Article 10: Clinical trials can only be carried out:
p.(None): - under the direction and under the supervision of a doctor who can demonstrate appropriate experience;
p.(None): - under material and technical conditions adapted to the clinical trial and compatible with
p.(None): imperatives of scientific rigor and safety of the people who lend themselves to this test;
p.(None): Article 11: Any serious effect likely to be due to research on a pharmaceutical product must be
p.(None): declared by the promoter, to the Minister of Health, Population and Hospital Reform,
p.(None): in accordance with the form attached in Annex D to this Order.
p.(None): Article 12: Minors and people admitted to a health or social establishment cannot be
p.(None): asked for a clinical trial only if we can expect a direct benefit for their health.
p.(None): Exceptionally pregnant and nursing mothers may be admitted to trials
p.(None): clinics if they do not face any foreseeable serious risk to their health or that of their child
p.(None): and that this research be useful for understanding the phenomena of pregnancy, childbirth or
p.(None): breastfeeding and if it cannot be done otherwise.
p.(None): Article 13: People who cannot take part in clinical trials are:
p.(None): - persons deprived of their liberty by a judicial or administrative decision;
p.(None): - patients in emergency situations and people hospitalized without consent.
p.(None): Article 14: For clinical trials without direct individual benefit, the sponsor assumes, even without
p.(None): fault, compensation for the harmful consequences of the test for the person who lends himself and that
p.(None): of his assigns, without being able to oppose the act of a third party or the voluntary withdrawal of the
p.(None): person who had initially agreed to participate in this test.
p.(None): For clinical trials with direct individual benefit, the sponsor assumes compensation for the consequences
p.(None): harmful to the test for the person who lends himself and that of his assigns, unless proven to his
p.(None): charges that the damage is not attributable to his fault or that of any intervener without that can be opposed
p.(None): made by a third party or the voluntary withdrawal of the person who originally consented to participate in the clinical trial.
p.(None): Article 15: The promoter is required to take out insurance guaranteeing his civil liability for the activity
...
Social / Property Ownership
Searching for indicator property:
(return to top)
p.(None): no opinion ;
p.(None): - the amendment profoundly modifies the protocol and the possible risks for patients. In this case, the committee
p.(None): of ethics deliberates and must give an opinion (favorable or not) on the amendment.
p.(None): AMM (Marketing Authorization)
p.(None): Administrative authorization issued by the Director of Pharmacy and Equipment to
p.(None): the pharmaceutical establishment which wishes to put a drug on the Algerian market. The director
p.(None): of Pharmacy and Equipment makes its decision following the advice of the committee of experts
p.(None): clinicians.
p.(None): archiving
p.(None): All clinical trial documents must be kept for 15 years after the end of the trial,
p.(None): both by the investigators and by the sponsor.
p.(None): Quality assurance
p.(None): System set up to ensure the quality of a clinical trial, the reliability of its results and compliance with
p.(None): ethics and law during the essay. It includes :
p.(None): - the quality controls carried out by the clinical research assistant
p.(None): - the audit
p.(None): - the inspection carried out by the competent administrative authorities
p.(None): Audit
p.(None): Analysis procedure of a clinical trial, carried out by an independent auditor of the trial and mandated by the
p.(None): promoter in order to ensure the quality of the test, the reliability of its results and respect
p.(None): during the test of the ethics, the law and the regulations in force. The audit report is the property of
p.(None): promoter who carried out the financial burden of the audit.
p.(None): Direct individual benefit (BID)
p.(None): Clinical research is said to have direct individual benefit when patients included in the trial
p.(None): will directly benefit from a possible therapeutic benefit for the management of their pathology.
p.(None): Conversely, any other clinical research is said to have no direct individual benefit when the subjects
p.(None): healthy or the patients included in the trial do not shoot
p.(None): no direct therapeutic benefit from the research in which they agreed to participate.
p.(None): Good Clinical Practice (GCP)
p.(None): Set of provisions which guarantee the quality and authenticity of information in clinical research
p.(None): collected and compliance with the law and regulations guaranteeing the rights of people in research
p.(None): clinical.
p.(None): bioavailability
p.(None): Study of the speed and the rate of release of the active principle of a pharmaceutical preparation, determined by
p.(None): its concentration curve in general circulation as a function of time or by its excretion
p.(None): in the urine.
p.(None): bioequivalence
p.(None): Two drugs are bioequivalent if they are pharmaceutically equivalent and if their bioavailability
p.(None): (rate and release rate), after administration of the same molar dose, is close enough that one can
p.(None): can expect essentially the same effects.
p.(None): Investigator's brochure:
p.(None): Refers to the comprehensive set of information collected at a given time on a drug, at the development stage
p.(None): where it is before the AMM. The investigator's brochure must be given before the start of a trial
p.(None): clinical to any investigator participating in this trial.
p.(None): The trial sponsor is responsible for writing and regularly updating the brochure (dated, signed).
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
(return to top)
p.(None): Article 19: The procedures determining the standards and methods applicable to the testing of products
p.(None): pharmaceuticals are set by order of the Minister of Health, Population and Hospital Reform.
p.(None): Article 20: Clinical trials must be carried out in accordance with the rules of good practice
p.(None): laboratory and rules of good clinical practice.
p.(None): Chapter 3: Consent of the person
p.(None): Article 21: Prior to carrying out a clinical trial on a person, free consent,
p.(None): informed and express of it must be collected after the investigator has made known to him:
p.(None): - the objective of the test, its methodology and its duration;
p.(None): - the expected benefits, the constraints and the foreseeable risks including in the event of the trial being stopped
p.(None): before its term.
p.(None): Article 22: The investigator must inform the person whose consent is sought of his right to
p.(None): refuse to participate in research or withdraw consent at any time without incurring any liability.
p.(None): Article 23: Consent is given in writing or, if this is not possible, it is certified by a third party. This
p.(None): the latter must be completely independent of the investigator and the promoter.
p.(None): Chapter 4: Protection of persons participating in clinical trials
p.(None): Article 24: Any clinical trial project must be submitted by the sponsor with the prior opinion of the ethics committee
p.(None): for clinical trials created in section 25 below.
p.(None): The ethics committee for clinical trials has one month from the date of receipt of the project
p.(None): to give his opinion.
p.(None): Article 25: The Minister of Health creates, in each health region, one or more committee (s)
p.(None): of ethics for clinical trials.
p.(None): The ethics committees for clinical trials have their seat in public health establishments.
p.(None): The organizational and operating procedures for ethics committees for clinical trials are set by
p.(None): instruction.
p.(None): Article 26: The ethics committee for clinical trials is an independent body, consisting of nine
p.(None): (09) people:
p.(None): - five (05) doctors including a general practitioner;
p.(None): - a pharmacist ;
p.(None): - a senior health technician;
p.(None): - a lawyer ;
p.(None): - a representative of patient associations.
p.(None): The ethics committee for clinical trials may call on any person likely to help it in
p.(None): his works.
p.(None): Article 27: The committee gives its opinion on the conditions of validity of the research with regard to
p.(None): the protection of individuals, in particular their information before and during the duration of the research and on the
p.(None): procedures for obtaining their consent, any compensation due, general relevance
p.(None): of the project and the adequacy between the objectives pursued and the means implemented as well as the qualification of the or
p.(None): investigators.
p.(None): Article 28: The Minister of Health, Population and Hospital Reform may dissolve a
p.(None): ethics committee for clinical trials if the conditions of independence, composition or
p.(None): necessary to ensure its mission are no longer met.
p.(None): Article 29: The activities of the ethics committees for clinical trials are supervised by the control unit
p.(None): clinical trials attached to the pharmacy directorate of the Ministry of Health, Population and
p.(None): hospital reform.
p.(None): Chapter 5: Special provisions for clinical trials without direct individual benefit (SBID)
p.(None): Article 30: Clinical trials without direct individual benefit must not involve any risk
p.(None): predictable serious for the health of people who lend themselves to it. They must be preceded by a medical examination
p.(None): of the people concerned. The results of this examination are communicated to them before
p.(None): expressing their consent.
p.(None): Article 31: In the case of a clinical trial without direct individual benefit to the people who go there
p.(None): lend, the promoter can pay these people compensation in compensation for the constraints suffered.
p.(None): Article 32: The number of clinical trials without direct individual benefit in which a volunteer can participate cannot
p.(None): exceed three (03) per year.
p.(None): Article 33: No one can lend himself to several biomedical researches simultaneously.
p.(None): Article 34: Clinical trials carried out on minors may in no case give rise to the
p.(None): payment of the compensation provided for in article 31 above.
p.(None): Article 35: Clinical trials without direct individual benefit can only be carried out in
p.(None): structures approved by the Minister of Health, Population and Hospital Reform.
p.(None): Article 36: Trials without therapeutic purpose are subject to the prior opinion of the National Council of
p.(None): Health Sciences Ethics.
p.(None): Chapter 6: Miscellaneous and final provisions
p.(None): Article 37: The Ministry of Health, Population and Hospital Reform maintains a register
p.(None): declaration of clinical trials in accordance with the model attached in Annex C to this Order.
p.(None): Article 38: The provisions of decrees n ° 44 of September 21, 1998 and n ° 48 of October 7, 1998 referred to above, are repealed.
p.(None): Article 39: This order will be published in the official bulletin of the Ministry of Population Health and
p.(None): hospital reform.
p.(None): People's Democratic Republic of Algeria Ministry of Population Health and Hospital Reform
p.(None): Order No. 388 of July 31, 2006
p.(None): setting the procedures for carrying out a clinical trial
p.(None): - Having regard to Executive Decree No. 93-53 of June 28, 1993, creating the official bulletin of the Ministry of
p.(None): health and population;
p.(None): - Having regard to Executive Decree No. 96-66 of 7 Ramadhan 1416 corresponding to January 27, 1996, fixing the attributions of the
p.(None): Minister of Health and Population;
p.(None): - In view of Executive Decree No. 05-428 of 5 Choual 1426 corresponding to November 7, 2005 on the organization of
p.(None): the administration of the Ministry of Health, Population and Hospital Reform;
p.(None): - Given Presidential Decree No. 06-176 of 27 Rabie Ethani 1427 corresponding to May 25, 2006
p.(None): appointing members of the Government;
p.(None): - Considering decree n ° 387 of July 31, 2006 relating to clinical trials.
p.(None): Stopped
p.(None): Article 1: The purpose of this decree is to fix the procedures for carrying out a clinical trial.
p.(None): Article 2: The request for a clinical trial may come from:
p.(None): - pharmaceutical laboratories;
p.(None): - medical practitioners in the context of research;
p.(None): - administrative authorities in connection with the registration of a pharmaceutical product;
p.(None): - research institutions within the framework of research projects;
p.(None): - service companies in the field of clinical trials.
p.(None): Article 3: The clinical trial applicant files a file at the level of the direction in charge of the pharmacy of the
p.(None): Ministry of Health, Population and Hospital Reform, comprising the following documents:
p.(None): - the declaration of intention to carry out a clinical trial in accordance with the form established for this purpose;
p.(None): - the clinical trial protocol as provided for in article 7 below;
p.(None): - the observation book;
p.(None): - the investigator's brochure;
p.(None): - a copy of the civil liability insurance contract taken out by the promoter;
p.(None): - a copy of the financial agreement between the promoter and the investigator.
p.(None): The above documents must be submitted in duplicate.
p.(None): The dossier must be submitted at least two months before the scheduled start of the test.
p.(None): Article 4: The directorate in charge of pharmacy of the Ministry of Health, Population and Reform
p.(None): hospital has a maximum of three months from the filing of the file mentioned in article 3
p.(None): above, to issue the authorization to carry out the clinical trial, to the applicant.
p.(None): Article 5: The request to carry out a clinical trial may be rejected in the following cases:
p.(None): - when the file is incomplete;
p.(None): - when the ethics committee for clinical trials has issued an unfavorable opinion;
p.(None): - when the clinical trial protocol does not respect the methodological principles described in the
p.(None): good clinical practice;
p.(None): - when the place of performance of the clinical trial does not meet the conditions appropriate to
p.(None): the clinical trial as defined by instruction from the Minister of Health, Population and
p.(None): of hospital reform.
p.(None): Article 6: The sponsor appoints an investigator to direct and monitor the performance of the clinical trial.
p.(None): In the case of a multicentre clinical trial, the sponsor entrusts the execution of the trial to several
p.(None): investigators, he appoints a principal investigator called the coordinating investigator.
p.(None): Article 7: The clinical trial is subject to a protocol which is signed by the investigator after he has
p.(None): expressed his agreement.
p.(None): Article 8: The investigator must inform the promoter of any critical event occurring during
p.(None): the clinical trial.
p.(None): In the event that this event results in a significant change to the clinical trial protocol, it
p.(None): must be notified to the ethics committee for clinical trials.
p.(None): Article 9: The investigator and his team must remain available for the duration of the clinical trial.
p.(None): The investigator must inform the director of the hospital establishment where the clinical trial is taking place, before
p.(None): the start of it.
p.(None): Article 10: When the products subject to the clinical trial do not have a marketing authorization
p.(None): the market in Algeria, an authorization for their customs clearance is issued by the direction in charge of
p.(None): the pharmacy of the Ministry of Health, Population and Hospital Reform.
p.(None): Article 11: When there are products left at the end of the clinical trial, the management of the pharmacy will issue a
p.(None): authorization for their destruction.
p.(None): Article 12: At the end of the clinical trial, the sponsor must send to the management responsible for
p.(None): pharmacy of the Ministry of Health, Population and Hospital Reform a report on the progress of
p.(None): the test and the results obtained.
p.(None): Article 13: The carrying out of a bioequivalence or bioavailability study is subject
p.(None): the same procedure as the clinical trial.
p.(None): Article 14: For the realization of an observational study, the promoter must only deposit at the level of the
p.(None): Department of Pharmacy of the Ministry of Health, Population and Reform
p.(None): hospital, the clinical trial protocol and the declaration of intent form
p.(None): clinical trial established for this purpose.
p.(None): Article 15: This decree is published in the official bulletin of the Ministry of Health, Population and
p.(None): hospital reform.
p.(None): ANNEX A
p.(None): Glossary
p.(None): Amendment
p.(None): Text amending a provision of a clinical research protocol already approved by an ethics committee.
p.(None): The principal investigator of the trial sends the amendment to the ethics committee.
p.(None): Two possibilities :
p.(None): - the amendment does not significantly change the protocol. In this case, the ethics committee is informed but does not give
p.(None): no opinion ;
p.(None): - the amendment profoundly modifies the protocol and the possible risks for patients. In this case, the committee
p.(None): of ethics deliberates and must give an opinion (favorable or not) on the amendment.
p.(None): AMM (Marketing Authorization)
p.(None): Administrative authorization issued by the Director of Pharmacy and Equipment to
p.(None): the pharmaceutical establishment which wishes to put a drug on the Algerian market. The director
p.(None): of Pharmacy and Equipment makes its decision following the advice of the committee of experts
p.(None): clinicians.
p.(None): archiving
p.(None): All clinical trial documents must be kept for 15 years after the end of the trial,
p.(None): both by the investigators and by the sponsor.
p.(None): Quality assurance
p.(None): System set up to ensure the quality of a clinical trial, the reliability of its results and compliance with
p.(None): ethics and law during the essay. It includes :
p.(None): - the quality controls carried out by the clinical research assistant
p.(None): - the audit
p.(None): - the inspection carried out by the competent administrative authorities
p.(None): Audit
p.(None): Analysis procedure of a clinical trial, carried out by an independent auditor of the trial and mandated by the
p.(None): promoter in order to ensure the quality of the test, the reliability of its results and respect
p.(None): during the test of the ethics, the law and the regulations in force. The audit report is the property of
p.(None): promoter who carried out the financial burden of the audit.
p.(None): Direct individual benefit (BID)
p.(None): Clinical research is said to have direct individual benefit when patients included in the trial
p.(None): will directly benefit from a possible therapeutic benefit for the management of their pathology.
...
p.(None): 9. Scheduled date for the start of the search: / / /
p.(None): 10. Expected duration:
p.(None): MEDICINE OR STUDY PRODUCT
p.(None): (If the trial involves several drugs or products, use one page for each of them)
p.(None): 11. Special name:
p.(None): 12. Code name:
p.(None): 13. Scientific name and D.C.I of the active principle (s):
p.(None): 14. Pharmaceutical form (pharmacopoeia):
p.(None): 15. Qualitative and quantitative composition (using international non-proprietary names):
p.(None): 16. New active ingredient: yes no
p.(None): 17. Dosage:
p.(None): 18. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): 19. D. E or A.M.M:
p.(None): - Algeria: yes no refusal suspension withdrawal
p.(None): - Abroad (name the main countries):
p.(None): REFERENCE MEDICINAL PRODUCT
p.(None): 20. Special name:
p.(None): 21. Scientific name and INN of the active principle (s):
p.(None): 22. Pharmaceutical form (pharmacopoeia):
p.(None): 23. Qualitative and quantitative composition of active ingredients (using common names
p.(None): international):
p.(None): 24. Dosage:
p.(None): 25. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): PLACEBO
p.(None): 26. Pharmaceutical form (pharmacopoeia):
p.(None): 27. Manufacturer (s) [name (s) or name (s) and place (s) of manufacture):
p.(None): INVESTIGATIVE (S)
p.(None): 28. Last name (s) and First name (s)
p.(None): 31. Quality
p.(None): 32. Place of performance
p.(None): PEOPLE LOOKING FOR RESEARCH
p.(None): 29. Expected number of people:
p.(None): 30. Therapeutic indication:
p.(None): 31. Main inclusion criteria:
p.(None): 32. Duration of treatment or participation per person:
p.(None): ETHICS COMMITTEE
p.(None): 33. Committee (name and address:
p.(None): 34. Favorable opinion Unfavorable opinion
p.(None): 35. Date of notice:
p.(None): INSURANCE
p.(None): 36. Insurance company (name or name):
p.(None): 37. Number of contract signed:
p.(None): Send 3 copies of this declaration to the DPHM
p.(None): APPENDIX D
p.(None): DATASHEET OF A SERIOUS ADVERSE EVENT
p.(None): STUDY :
p.(None): PROTOCOL:
p.(None): 1. INFORMATION ABOUT THE PATIENT:
p.(None): Last name First Name :
p.(None): Patient number
p.(None): Gender: F M
p.(None): Date of Birth :
p.(None): Weight height :
p.(None): 2. DECLARING
p.(None): Promoter:
p.(None): Name: Position:
p.(None): Telephone: Fax:
p.(None): Investigator:
p.(None): Test center:
p.(None): Name: Position:
p.(None): Telephone: Fax:
p.(None): 3 ADMISSIBLE DRUGS
p.(None): Drug (s
p.(None): ) of the study
p.(None): way
p.(None): Dose
p.(None): Dated
p.(None): From start to stop
p.(None): Reason for prescription
p.(None): Drug (s
p.(None): ) associated
p.(None): way
p.(None): Dose
p.(None): Dated
p.(None): From start to stop
p.(None): Reason for prescription
p.(None): 4. DESCRIPTION OF THE EVENT
p.(None): (clinical and paraclinical signs)
p.(None): Date of occurrence (day, month, year): / / / / / / / / / /
p.(None): Delay after the last dose (day, hour, minute): / / / / / / / / / /
p.(None): Evolution: - Spontaneous regression yes no
p.(None): - Regression under treatment yes no
p.(None): Corrector: - Persistence: yes no - Worsening: yes no
p.(None): Accountability: - Excluded: yes no - Possible: yes no
p.(None): - Likely: yes no - Very likely: yes no
p.(None): Taken measures :
p.(None): Any
p.(None): Corrective treatment
p.(None): Stopping the suspected drug
p.(None): Re-administration of the suspected product: YES NO Recurrence of the event:
p.(None): YES NO
p.(None): 5. COMMENTS
...
General/Other / Public Emergency
Searching for indicator emergency:
(return to top)
p.(None): and on sufficient pre-clinical experimentation;
p.(None): - if the foreseeable benefit / risk ratio is not for the benefit of the subject included in the research.
p.(None): Article 10: Clinical trials can only be carried out:
p.(None): - under the direction and under the supervision of a doctor who can demonstrate appropriate experience;
p.(None): - under material and technical conditions adapted to the clinical trial and compatible with
p.(None): imperatives of scientific rigor and safety of the people who lend themselves to this test;
p.(None): Article 11: Any serious effect likely to be due to research on a pharmaceutical product must be
p.(None): declared by the promoter, to the Minister of Health, Population and Hospital Reform,
p.(None): in accordance with the form attached in Annex D to this Order.
p.(None): Article 12: Minors and people admitted to a health or social establishment cannot be
p.(None): asked for a clinical trial only if we can expect a direct benefit for their health.
p.(None): Exceptionally pregnant and nursing mothers may be admitted to trials
p.(None): clinics if they do not face any foreseeable serious risk to their health or that of their child
p.(None): and that this research be useful for understanding the phenomena of pregnancy, childbirth or
p.(None): breastfeeding and if it cannot be done otherwise.
p.(None): Article 13: People who cannot take part in clinical trials are:
p.(None): - persons deprived of their liberty by a judicial or administrative decision;
p.(None): - patients in emergency situations and people hospitalized without consent.
p.(None): Article 14: For clinical trials without direct individual benefit, the sponsor assumes, even without
p.(None): fault, compensation for the harmful consequences of the test for the person who lends himself and that
p.(None): of his assigns, without being able to oppose the act of a third party or the voluntary withdrawal of the
p.(None): person who had initially agreed to participate in this test.
p.(None): For clinical trials with direct individual benefit, the sponsor assumes compensation for the consequences
p.(None): harmful to the test for the person who lends himself and that of his assigns, unless proven to his
p.(None): charges that the damage is not attributable to his fault or that of any intervener without that can be opposed
p.(None): made by a third party or the voluntary withdrawal of the person who originally consented to participate in the clinical trial.
p.(None): Article 15: The promoter is required to take out insurance guaranteeing his civil liability for the activity
p.(None): that he undertakes.
p.(None): Article 16: The clinical trial does not give rise to any direct or indirect financial compensation for
p.(None): persons who lend themselves to it, except reimbursement of expenses incurred by the person who
p.(None): ready for clinical trial.
p.(None): Article 17: The carrying out of any clinical trial is subject to a financial agreement between the promoter
p.(None): and the investigator.
p.(None): The promoter enters into a financial agreement with the establishment in the event that the clinical trial generates
p.(None): additional costs.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| blind | visual impairment |
| drug | Drug Usage |
| emergency | Public Emergency |
| hospitalized | hospitalized patients |
| liberty | Incarcerated |
| mothers | Mothers |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| pregnant | Pregnant |
| property | Property Ownership |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protection
risk
volunteer
Applicable Type / Vulnerability / Indicator Overlay for this Input