GCP Booklet

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP. 21 CFR Part 50, 54, 56 along with the other regulations govern the good clinical practices. These regulations also provide assurance of the safety of the new drug candidates under development.

The GCP booklet App presents the regulations for good clinical practices in a user-friendly e-format. The users can easily reach to each section of regulations with customized view options. This is a convenient information and reference tool for all people working in pharmaceutical and biotech industry and researchers conducting clinical research.

Keywords : Good Clinical Practices (GCP), clinical trial, clinical research, human subject protection, FDA, Regulation, Regulatory