Faculty Conducting Human Subjects Research
To all faculty conducting Human Subjects Research:
The School of Medicine recently issued a policy regarding the requirement to register studies and report results on ClinicalTrials.gov for (1) studies that are applicable clinical trials (ACTs) according to FDAAA and (2) studies that meet the NIH clinical trial definition and are funded by NIH. The policy is now posted on the Clinical Research Quality website along with a link to the NIH policy notice.
School of Medicine Policy on Clinical Trials Disclosure (ClinicalTrials.gov)
A PDF file of the policy is available in Stanford Medicine box here:
https://stanfordmedicine.app.box.com/s/i6ey6ntzujijr1i5rdknlclk0rla6r0e
Clinical Research Quality website
NIH policy on Dissemination of NIH-Funded Clinical Trial Information
https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-149.html
NIH clinical trial definition
http://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html
Sr. Associate Dean of Research, Harry Greenberg, and incoming Sr. Associate Dean of Research, Mark Cullen, highly recommend that PI’s become knowledgeable about both policies and requirements. If you have any questions about ClinicalTrials.gov please contact SCCR's Quality and Compliance Manager Maya Berdichesky (mayab2@stanford.edu), or the Clinical Research Quality Office (clinicaltrials-gov@stanford.edu), which provides information, training and guidance.