The final rule for Clinical Trials Registration and Results Information Submission (42 CFR Part 11) clarifies and expands requirements for submitting clinical trial registration and results information to ClinicalTrials.gov.
Effective date for the final rule is January 18, 2017 and the compliance date is April 18, 2017.
A full analysis of the Final Rule is available at:
Zarin DA, Tse T, Williams RJ, Carr S. Special Report Trial Reporting in ClinicalTrials . gov — The Final Rule. 2016;375(20):1998-2004. Available from: http://www.nejm.org/doi/full/10.1056/NEJMsr1611785#t=article
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