As announced at the July 2017 Research Administrator’s Forum (RAF), the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) have made recent policy changes related to clinical trials. As such, a number of changes have been made to the EPASS and eDGE Disclosure Tracking forms. A summary of changes is provided below, and more detailed information is available in the attached RAF presentation.
EPASS
- Section 6: Proposal Checklist – added question, “NIH-funded Clinical Trial?
- Section 10: Approvals/Certifications – added language regarding ClinicalTrials.gov requirements.
- Page 3 – added a table to track Good Clinical Practice training.
eDGE Annual Financial Disclosure Tracking form
- Updated and revised to include tracking of Good Clinical Practice training for NIH-funded clinical trials.
- Renamed form to address this change (eDGE Annual Financial Disclosure/GCP Training Tracking)
- Added certification language to the Principal Investigator Signature(s) section regarding ClinicalTrials.gov requirements.
If you have saved previous versions of the forms on your local computer, please replace them with the versions dated 08/24/17:
To ensure that we have the most current and accurate data, OCGA cannot accept previous versions of the EPASS or eDGE/GCP Disclosure Tracking forms after September 30, 2017. Forms that are in process, and submitted prior to September 30, do not need to be updated to the new form. The forms are also available on the OCGA website.
Please contact your OCGA Team if you have questions.