TRAINING NEEDS FOR CPP MEMBERS IN FRANCE

Transcription

1 TRAINING NEEDS FOR CPP MEMBERS IN FRANCE Professeur Sylvie Hansel-Esteller EFGCP Bruxelles 30-31/01/2007

2 Les comités de protection des personnes Long experience since 1988 date of implementation of the law: " loi Huriet-Sérusclat about the protection of the persons who participate to a biomedical research " The implementation of the European Directive 2001/20/EC did not change too much our practices but increased our responsibility and field

3 French organisation of CPP (EC) 40 "Comités de Protection des Personnes" (ethics committee) localized in the whole country Single opinion for France: each CPP has a national competence (an opinion of one committee is valid for multicentre trial in France) Each committee is composed of 14 members and 14 substitute The composition is multidisciplinary: biomedical, ethical, social, psychological, law The committee is organized in two groups: one medical and one non-medical

4 Composition of the committee College 1: medical 4 persons qualified in biomedical research (physicians, biostatisticians, researchers ) 1 general practitioner 1 hospital pharmacist 1 nurse College 2: non medical 1 person specialized in ethics 1 psychologist 2 lawyers 1 social worker 2 patients

5 Organisation Committees have generally one monthly meeting, some of them have two The sponsor sends his application form two weeks before the session The president of the committee designed two reviewers from each college: one "medical" and one "ethical by dossier The committee reviews 5 or 6 clinical trials forms and about 20 substantial amendments by meeting The delay is 35 days and 60 in case of request of information and modifications of the protocol

6 Basis of the opinion of the committee Ethical, scientific, methodological and statistical considerations Protection of trial subjects Protection of human rights, dignity and wellbeing of persons Benefits and risks ratio Trial centre: quality of the facilities Qualification and suitability of investigators Subject information and informed consent procedures Recruitment procedure Etc

7 Basis of the training Law and regulatory documentation Ethical principles Biomedical research conception Subject information format and contents GCP Bioethics and pharmacogenetic, pharmacogenomic trials Quality assurance

8 Basis of the training How to review investigator s brochure, protocol and all the documents contained in the application file How to review subject written information: specific information linked to the trial and necessary for the subject to decide whether or not to participate General information about protection of the rights, confidentiality of personal data, insurance and indemnity system, quality control etc

9 Basis of the training The needs are different in the two colleges College 1: Law and regulatory documentation, ethics, subject information format and content, GCP College 2: Biomedical research conception, investigator s brochure, law and regulatory documentation, ethics, subject information format and content, GCP

10 Others needs Advice procedure Benefits / risks ratio evaluation Functioning procedure: harmonization Quality assurance Analysis chart

11 Regulatory harmonization Common detailed guidelines for the functioning of CPP Covering letter Application form Clinical trial protocol Notification of substantial amendments Safety measures and adverse events GCP

12 Training organisation / CNCP Training organized by CNCP (conference nationale des comités de protection des personnes) CNCP Annual Meeting during two days with several workshops Permanent groups: Functioning and harmonization Training Pediatrics National guidance of GP Quality assurance Bioethics Information and communication Medical devices Europe (Eurec)

13 Training organisation Detailed guidance by Ministry of Health (in going) Training sessions organized locally by committees Training meeting organized by regional clinical research departments for committees members, institutional sponsors and investigators Special training and information meeting for patients - members of committees Education and Training University : Master Several websites: Ministry of Health, Afssaps, CNCP with all regulatory and administrative documents and references