chapter  18
10 Pages

Regulatory Issues in Clinical Trials

ByAnthony C. Arnold

Investigators who perform clinical trials on human subjects in the United States must recognize certain established principles with regard to recruiting and maintaining subjects and must adhere to the policies of both local (Institutional Review Board, IRB) and federal (Food & Drug Administration, FDA) regulatory agencies. Coordination with sponsoring pharmaceutical company policies is essential in all aspects, particularly as compromises may be necessary to satisfy the requirements of all agencies involved.