Good Clinical Practices (GCP)
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Who Should Attend
This course is intended to train individuals in the pharmaceutical
and biopharmaceutical industries involved in all phases of
clinical research including:-
Clinical Research Monitors
- Clinical Research Associates
- Clinical Research Coordinators
- Clinical Investigators
- Clinical Regulatory
- Statisticians
- Medical Communications
These Good Clinical Practice (GCP) regulations and EU
Directives are to assure the validity of data resulting from all
phases of clinical research.
Description
Good Clinical Practice (GCP) procedures entail the
obligations of Investigators, Sponsors, and Monitors and their
staff in the conduct and legal aspects of clinical research in
the process of new product development. This course will
emphasize the specific responsibilities and obligations of all
individuals involved in clinical research for international New
Drug Applications. Selection of investigators and research
facilities will be coordinated with pre-investigational site visits.
Monitors will learn how to orient investigators and their staffs
to follow CRFs in the conduct of clinical research. CRCs will
learn their obligations in relation to participating with the
investigator in clinical research. The responsibilities of
sponsors and monitors assuring that Informed Consent and
IRBs/IECs and privacy regulations are adhered to will be
presented.
FDA’s Clinical Bio-Research Monitoring Program (BIMO)
and EU Directives monitoring program will be discussed.
The practical procedures in training monitors in how to audit
clinical research data and how to avoid mis-entries and
correct case report forms while complying with regulations
will be detailed. The procedures in reporting adverse
experiences and adverse reactions in order to meet FDA and
international regulations will also be presented. Participants
will have the opportunity to attend a workshop that will give
the learner a practical exercise in monitoring obligations.