The following resources are provided to help investigators, sponsors, and contract research organizations who conduct clinical studies on investigational new drugs comply with U.S. law and

All researchers are obliged to follow the very detailed principles/rules of the International Conference on Harmonization—Good Clinical Practice (GCP). GCP is an international ethical and

The Good Clinical Laboratory Practices (GCLP) concept possesses a unique quality, as it embraces both the research and the clinical aspects of GLP. The development of GCLP standards encompasses applicable portions of 21 CFR parts 58 (GLP) and 42 CFR part 493 (Clinical Laboratory Improvement Amendments -CLIA) .

Good clinical practice ( GCP) is a set of internationally-recognised ethical and scientific quality requirements that must be followed when designing, conducting, recording and reporting
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  • what is gcp in clinical research