[Evaluation criteria for protocols submitted to the consultant committee for protection of persons in biomedical research (CCPPRB) Lyon-C].
In order to fulfill its task, the Lyon-C institutional review board (CCPPRB) developed standards for the evaluation of clinical research protocols. This check-list envisages 1- the mandatory documents in the absence of which the protocol will not be considered, 2- scientific quality standards, 3- ethical quality standards. An agreement on the use of such standards in France might improve the functioning of institutional review boards (CCPPRB) and the quality of clinical research.
Lièvre
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Unité de Pharmacologie Clinique, Lyon.
D002985:Clinical Protocols; D003253:Consultants; D004992:Ethics, Medical; D005069:Evaluation Studies as Topic; D005602:France; D008503:Medical Staff; D011367:Professional Staff Committees; D015397:Program Evaluation; D011786:Quality Control; D012106:Research / Q000331:legislation & jurisprudence
Critères d'évaluation des protocoles soumis au comité consultatif de protection des personnes dans la recherche biomedicale (CCPPRB) Lyon-C.