Is GCP training mandatory

the requirement to complete this training is usually determined by your funding source. all investigators and staff who are involved in the conduct, oversight or management of nih funded clinical trials are required to complete training in good clinical practice (gcp) and refresh this training every 3 years, consistent with principles of the international conference on harmonisation (ich) e6 (r2) . *nih may require those with nih funded studies to complete the gcp training prior to this date. other sponsors may also require this training; you will need to check with the sponsor to see if they have specific gcp training requirements. investigators at the university of iowa that are required to complete gcp training can complete an education program through the collaborative institutional training initiative program (citi). you will automatically be enrolled in the basic gcp course.

you will receive automated reminder emails from citi prior to the expiration date of your gcp certification. these will be sent out at 90 days, 30 days and 7 days prior to the expiration date of the last completed stage. the hso does not keep copies of individual citi program course completion records. if your study is not funded by the nih, but by another sponsor, you will need to check with the sponsor to see what their requirements are for gcp training. due to programming constraints within the citi website, there is no way to distinguish learners who are completing gcp training for an nih funded study from those that are completing gcp training for a different sponsor that may not require gcp training to be renewed every 3 years. even if your sponsor does not require renewal, you may still receive the automated email reminders from citi that your gcp training will expire soon.

recipients of gcp training are expected to retain documentation of their training. gcp training should be refreshed at all investigators and staff who are involved in the conduct, oversight or management of nih funded clinical trials are required to complete training in good clinical practice (gcp) and refresh this training every 3 years, consistent with principles of the international conference on harmonisation (ich) e6 (r2) . in the fall of 2009, fda’s critical path initiative launched a clinical investigator training course targeted , good clinical practice training, good clinical practice training, who needs gcp training, is gcp training required by the fda, gcp training citi.

eligibility criteria. nihr crn gcp courses are available free of charge to the nhs, uk universities, and gcp consists of basic and refresher courses that provide essential good clinical practice training for research teams effective , training in good clinical practice (gcp) is required for all nih-funded investigators and staff , transcelerate gcp training online free, niaid gcp training, ich gcp, gcp training answers

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