The Medicines for Human Use (Clinical Trials) Regulations 2004

Principles based on International Conference on Harmonisation GCP Guideline(1)

8.  Each individual involved in conducting a trial shall be qualified by education, training, and experience to perform his or her respective task(s).

(1)

See Section 2 of the Note for Guideline on Good Clinical Practice (CPMP/ICH/135/95) published by the European Agency for the Evaluation of Medicinal Products in July 2002.