South African good clinical practice guidelines. 2nd edition

South African good CLINICALPRACTICE GUIDELINESSECOND edition Suggested Citation: Department of Health, 2006. Guidelines for good Practicein the Conduct of clinical Trials with Human Participants in South Africa. Department of Health: Pretoria, South Africa. 2006 Department of HealthGuidelines for good practice in the Conduct of clinical Trials with Human Participants in South Africa1 PREAMBLEThis is the second edition of the Guidelines for good practice in the Conduct of clinical Trials in HumanParticipants in South Africa following those published in 2000. They have been revised by a workinggroup convened by the Director-General of the Department of Health that principally included represen-tatives from the Department of Health, the Medicines Control Council and the Interim MinisterialCommittee on Ethics in Health Research. The Guidelines are addressed to investigators including ethics review committees, pharmaceutical manufacturers and other sponsors of research, drug regulatory authorities, the general public and allthose who have an interest in clinical trials research in South Africa.

Guidelines for Good Practice in the Conduct of Clinical Trials with Human Participants in South Africa 5. 4.5 CONTRACT RESEARCH ORGANIZATION (CRO) 39 4.6 MEDICAL EXPERTISE 39 4.7 TRIAL DESIGN 39 4.8 TRIAL MANAGEMENT, DATA HANDLING, AND RECORD KEEPING 40 4.9 INVESTIGATOR SELECTION 41

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