Description of Collaborative Activity: |
ClinicalTrials.gov is a National Library of Medicine (NLM) operated database containing summary protocol and results information from publicly and privately funded clinical research studies. As of September 2019, the database included summary protocol information on nearly 318,000 clinical studies conducted in over 200 countries, with approximately 40,000 of these records displaying summary results. NLM originally collaborated with the Food and Drug Administration (FDA) on implementing Section 113 of the Food and Drug Administration Modernization Act of 1997. It subsequently collaborated with FDA, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC), and the National Institutes of Health (NIH) Office of the Director (OD) to implement the statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 through rulemaking. Regulations (42 CFR Part 11) were promulgated in September 2016. NLM continues its collaboration with FDA, OD/OSP, OGC, and other parts of NIH to implement the requirements under 42 CFR Part 11, provide educational information, conduct outreach activities, and develop compliance workflows and reporting tools. NLM is also continuing its collaborating with NIH OD and other parts of NIH to implement the 2016 NIH Policy on the Dissemination of NIH-funded Clinical Trial Information and other NIH policies (e.g., reporting results of valid analyses by sex/gender and race/ethnicity for NIH-funded trials to ClinicalTrials.gov as required by the 21st Century Cures Act). Additionally, NLM worked closely with OD/OSP to assist OHRP in implementing the Posting of Clinical Trial Consent Form provision of the revised Common Rule at 45 CFR 46.116(h). NLM has also been working with OD/OBSSR to develop resource materials specific to researchers in the field of behavioral and social science to better support submission of their research to ClinicalTrials.gov. Finally, NLM has been collaborating with OD/OSP, OER, OLPA, and OCPL on analyzing approaches for reporting NIH-funded basic experimental studies with humans. |
NIH Participating Institutes/Centers/Office of the Director: |
CC, NCATS, NCCIH, NCI, NCMHD, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NIBIB, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NIMHD, NINDS, NINR, NLM, OD/DPCPSI/OBSSR, OD/OER, OD/OLPA, OD/OSP |
