Question

GCP include protection of Human rights as a subject in a clinical trial.

(a) True

(b) False

The question was posed to me during an interview.

This intriguing question comes from Controlled Release Medication topic in portion Controlled Release Medication of Drug Biotechnology

Answer 1

Right answer is (a) True

The explanation: Good Clinical Practice includes protection of human rights as a subject in a clinical trial. It also provides assurance of the safety and efficacy of the newly developed compounds. GCP also includes standards on how clinical trials should be conducted, define the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. In the pharmaceutical industry, monitors are often called Clinical Research Associates.