Description of Collaborative Activity: |
ClinicalTrials.gov is an NLM-operated database containing summary protocol and results information from publicly and privately funded clinical research. As of December 2016, the database included summary protocol information on more than 230,000 clinical studies conducted in over 195 countries, with nearly 24,000 records displaying summary results. NLM originally collaborated with FDA on implementing Section 113 of the Food and Drug Administration Modernization Act of 1997. It subsequently collaborated with FDA and NIH OD to implement the statutory requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 through rulemaking. The final rule (42 CFR Part 11) was issued in September 2016. NLM is currently collaborating with FDA and other parts of NIH to implement the regulatory requirements of 42 CFR Part 11. |
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/OER, OD/OSP |
