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IRB

GCP Certification

 

The IRB at NCI-Egypt requires Good Clinical Practice (GCP) training and certification of the Principal Investigator (PI) and all research team members (co-investigators, coordinators, nurses, research fellows, students, etc) involved in the conduct of research with human subjects. This requirement applies to any research activity that involves obtaining consent, collection of data or biological specimens any research protocol regardless of funding, and including research determined by the IRB to be exempt from IRB oversight.

The NCI-Egypt Research Center periodically conduct GCP training courses and many of GCP courses are available online (both free and subscribed). Many sponsors and Clinical Research Organizations (CROs) also provide GCP training and certification. An example of the free online GCP training and certification is provided by US National Institute of Health (http://www.nihtraining.com/index.html). Click the Clinical Research Training link, Register for a new account and read the material provided and complete the questions provided at the end of each section. When all sections are completed you will be able to print your GCP training and certification.

The passing rate to achieve certification is set at 75%, and the course allows for re-taking the quiz at the end of each module to improve one's fund of knowledge and score. A signed and dated copy of the GCP certificate should be submitted to the IRB Office, attesting that all required modules have been completed. Principal Investigators are responsible for ensuring that all personnel involved their research protocols are certified. Re-certification is required every three years (36 months). Research proposals submitted by non-certified investigators will not be approved by the IRB and may not be conducted at NCI-Egypt or by NCI-Egypt personnel.