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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:
- An adequate understanding of basic GCP requirements
- An awareness of the composition and roles of clinical
research team members
- An understanding of the function and responsibilities
of Institutional Review Boards in the research process
- An understanding of the components of study protocols
and informed consent documents and how these documents are
utilized in clinical research
- An understanding of general clinical study documentation
requirements
- An understanding of general clinical study activities
from study initiation through completion
- 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
- The Evolution and Impact of GCP in US-Based Clinical
Research
- The Clinical Research Team (roles and responsibilities)
- Institutional Review Boards
- Study Protocol & Informed Consent Documents
- Essential Study Documents
- Study Initiation Activities
- Ongoing Study Activities
- Study Completion or Termination Activities
- 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:
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