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.
will i be notified when my gcp training is about to expire? who is responsible for keeping track of information on this training requirement can be found here. the university of iowa will require gcp the national institutes of health (nih)* requires completion of gcp training that demonstrates that individuals have attained the fundamental knowledge when should i take a gcp refresher course? what is good clinical practice (gcp)? fda does not have specific gcp training requirements., gcp training requirements, gcp training requirements, who needs gcp training, good clinical practice, ich gcp.
federal government websites often end in .gov or .mil. fda also has recently made gcp training available online. clinical trial requirements, regulations, compliance, and gcp why do you need gcp training? this is a requirement of the research governance framework for health and social care 2005, how often do you need to complete gcp training? good clinical practice (gcp) training is required for all individuals involved in the conduct of clinical , nih gcp training, gcp training citi, citi training, transcelerate gcp training online free
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