Changes are coming! Get ready. Get set. Apply early! Dr. Geeta Swamy provided the research community with a summary of NIH submission changes that will affect all NIH clinical trial applications. The changes are being implemented in order to increase efficiency, transparency, accountability, and timely reporting. The reforms and initiatives will affect all research involving human participants by using new forms to collect human subject information and by use of a single institutional review board for multi-site studies. Research that meets the NIH definition of a clinical trial will see changes in training for Good Clinical Practice, clinical trial-specific funding opportunity announcements, new review criteria, and expanded registration and results reporting in ClinicalTrials.gov.
Changes to forms collection will include 45 new data elements along with 14 new stand-alone attachments. Dr. Swamy provided the research community with a high level summary of these changes, along with many resources for additional information including a detailed guide available on the NIH website: https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/general-forms-e.pdf
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https://dukemed.mediasite.com/Mediasite/Play/afe46df605724886a160ea642e99017d1d
Presentation slides
https://duke.box.com/s/r835m0zas48q6u6mn07c376rzff3e3ng
Other materials
https://duke.box.com/s/cz5urg940fntj97a5yohyj37uymb82nl