Good Clinical Practice part

Two other documents are relevant to clinical trials the World Health Organisation (WHO) Guidelines for Good Clinical Practice for trials on pharmaceutical products, still used for clinical trials in some parts of the world, and the new EU Clinical Trial Directive. ... 

Clinical Trials, 1994. The rules of good clinical practice (GCP) have been partly incorporated in the Directives. A prominent feature is that it is the investigator rather than the sponsoring company who will be responsible for most aspects of the trial. Following are the main features of the rulings ... 

Contract research organizations (CROs) should be inspected as part of the assessment process to verify that raw data correspond to submitted data, and to assess compliance with standards during the conduct of clinical and bioequivalence studies. Monitoring and requalification should ensure that the principles of good clinical practices (GCP) (20), good practices for quality control laboratories (10) and GLP (19) are adhered to. 

Part IV. Global Applications of Good Clinical Practices (GCPs)... 

CFR Part 58 Good Laboratory Practices for Non-clinical Laboratory Stndies... 

CFR 21 Part 58 — Good Laboratory Practice for Non-clinical Laboratory Studies... 

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