Does FDA require GCP?

Yes, the Food and Drug Administration (FDA) conducts GCP training. As described below, the agency conducts some GCP training on site, but also partners with other federal agencies and organizations across the United States to conduct additional training.

What are the 13 principles of ICH GCP?

Ethics.

What is protocol in clinical trial?

The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

What to do if FDA is not following guidance?

You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you believe an FDA employee is not following FDA’s Good Guidance Practice regulations (21 CFR 10.115), you should contact the employee’s supervisor in the issuing office or Center.

What does the FDA mean by good clinical practice?

Good Clinical Practice FDA regulates scientific studies that are designed to develop evidence to support the safety and effectiveness of investigational drugs (human and animal), biological products, and medical devices.

Which is the FDA focal point for clinical trials?

FDA regulations and guidance documents, and international GCP guidance documents on which FDA has collaborated, and that have been adopted as official FDA guidance, are also found here . The Office of Good Clinical Practice (OGCP) serves as the FDA focal point for GCP and HSP issues related to FDA-regulated clinical trials.

What are the regulations for good clinical practice?

Federal Food, Drug and Cosmetic Act FDA Regulations Relating to Good Clinical Practice and Clinical Trials 21 CFR Part 11 – ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 21 CFR Part 50 – PROTECTION OF HUMAN SUBJECTS (Informed Consent)