PMI’s Clinical Research Investigator GCP Tutorial is a comprehensive, on-line program designed to provide efficient training for clinical research investigators 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 investigator 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. A basic understanding of GCP requirements
  2. An understanding of the clinical investigator’s role and responsibilities in the conduct of clinical studies
  3. An understanding of informed consent requirements and administration activities
  4. An understanding of general clinical study documentation requirements
  5. An understanding of general clinical study activities from study initiation through completion
  6. An understanding of the clinical research audit process.

The Investigator Tutorial program is divided into seven learning modules that address study responsibilities from the investigator's perspective. Each module may be completed within 20-30 minutes, dependent on Internet connection speed, prerequisite knowledge, etc.

Investigator Tutorial Learning Modules
- Background & Overview of Good Clinical Practice
- Responsibilities of Clinical Investigators
- Informed Consent Documents
- Documentation Requirements
- Undertaking a Clinical Study
- Completing a Clinical Study
- 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 Investigator Tutorial, please omplete the GCP Tutorial Registration Form:

 

 
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