Conducting Regulatory Research: The Good Laboratory Practices Series
FDA Guidance 218: Cell-Based Products – by Lynne Boxer, DVM Veterinary Medical Officer May 10, 2016
NIH Good Clinical Practice For Social and Behavioral Research – ELearning Course
NIH has made Good Clinical Practice training modules specific to social and behavioral research available for download. View the modules.
As you know, the NIH Policy on GCP Training takes effect January 1. Per NIH’s recent response to our October 6 letter, “institutions should not regard the policy’s effective date as a deadline by which we would expect all staff involved in the conduct, oversight, and management of clinical trials to be GCP trained. Rather, as long as steps are being taken to meet the expectation, e.g., staff who have not yet been trained have signed up for a course, the training itself can be taken in a timely fashion after the effective date.”
– Council on Governmental Relations