PMI's Clinical Research Coordinator GCP Tutorial is a comprehensive, on-line program designed to provide efficient training for clinical research coordinators performing studies in the U.S. The program is intended to provide background and guidance regarding the application of GCP in relation to industry-sponsored clinical research studies. It is appropriate for those who:

  • Are working as a study coordinator on a clinical trial for a drug, device or biologic product;
  • Are interested in keeping current on GCP; or
  • Need to document training in the area of GCP.

Upon completion of the tutorial, participants should have:

  1. An adequate understanding of basic GCP requirements
  2. An awareness of the composition and roles of clinical research team members
  3. An understanding of the function and responsibilities of Institutional Review Boards in the research process
  4. An understanding of the components of study protocols and informed consent documents and how these documents are utilized in clinical research
  5. An understanding of general clinical study documentation requirements
  6. An understanding of general clinical study activities from study initiation through completion
  7. An understanding of the clinical research audit process.

The Coordinator Tutorial program is divided into nine learning modules that address clinical study responsibilities from the coordinator’s perspective. Each module may be completed within 30-45 minutes, depending on Internet connection speed, prerequisite knowledge, etc.

Coordinator Tutorial Learning Modules

  1. The Evolution and Impact of GCP in US-Based Clinical Research
  2. The Clinical Research Team (roles and responsibilities)
  3. Institutional Review Boards
  4. Study Protocol & Informed Consent Documents
  5. Essential Study Documents
  6. Study Initiation Activities
  7. Ongoing Study Activities
  8. Study Completion or Termination Activities
  9. Clinical Research Audits

To learn more, please review Frequently Asked Questions about our program or set-up a demonstration.

If you wish to register for our Coordinator Tutorial, please download and complete the GCP Tutorial Registration Form: