Role of ICH-GCP in Good Clinical Practice GCP Study

Anyone directly or indirectly involved in a Clinical Trial is required to take GCP clinical research training including research site staff, supporting staff, contractors, and consultants to ensure adherence to the protocols. It must be repeated after every 3 years to assess and refresh the knowledge of all the members involved in the Clinical Trial, according to the GCP Good Clinical Practice guidelines, and to keep them updated in case of any change in the basics of Good Clinical Practice.

Participants of Good Clinical Practice GCP Study:

It is important to understand the roles and responsibilities of participants in GCP Clinical Research. These include:

Regulatory authorities:

Regulatory authorities are responsible for conducting inspections and submitting clinical trial data.

The Sponsor:

The Sponsor is a company or an organization that takes the responsibility for conducting and overseeing a clinical trial.

Monitor:

Monitor is appointed by a sponsor and responsible for looking after the whole clinical trial process.

Investigator:

Investigator is the leading Physician who is responsible for conducting and overseeing the entire clinical trial.

Patients:

Patients are the human subjects participating in the GCP clinical research.

Review Boards:

Review Boards are usually nominated by Institution or if not available then the health body of that country selects one.

Committee:

Committee overseas Sponsors (drug companies).