Good Clinical Practices (GCPs) are not a part of: (LQ)
|B||Phase I studies|
|C||Phase II studies|
|D||Phase IV studies|
a. Good clinical practice is not needed in preclinical stages rather good laboratory practices are needed. It is an international quality standard that was adopted by international conference on harmonization.
b. It was aimed to define roles and responsibility of clinical trial responsibilities. Guidelines for trial sponsor have also been given. Good laboratory practice includes good analytic practice.