A new e-learning training module is now available in BuckeyeLearn targeting social and behavioral researchers engaged in clinical trials of drugs, devices, biologics and/or behavioral interventions.
This training supports the NIH policy (issued September 16, 2016) stating that NIH-funded investigators and staff “who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2)”. GCP principles constitute an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical trials.
- Help assure the safety, integrity, and quality of clinical trials
- Provide a standard for ensuring clinical trial compliance, implementation, data collection, monitoring, and reporting (e.g., safety data, accrual reports, study status, protocol deviations, unanticipated problems, or final data)
- Outline the responsibilities of Institutional Review Boards (IRBs), investigators, sponsors and monitors
- Address elements related to the design, conduct, and reporting of clinical trials.