November 16, 2017

NIH Clinical Trial Stewardship Resources

Resources to help support NIH Clinical Trial Stewardship

Certificate of Confidentiality (CoC) Policy
> Office of Research CoC Guidance

Clinical Trial Definition from NIH

Human Subjects & Clinical Trial Information Form

Single IRB Policy
> HSD Single IRB guidance

Good Clinical Practice (GCP) Training
> MyResearch Training Transcript includes GCP training completion records from CITI

NIH: Clinical Trials Registration & Reporting Requirements
> HSD: Clinical Trial Registration & Reporting