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FDAAA 801, The Final Rule (42 CFR Part 11), and ClinicalTrials.Gov Registration
4. Zarin DA, Tse T, Williams RJ, Carr S. Trial reporting in ClinicalTrials.gov - the final rule. N Engl J Med. 2016 Nov 17;375(20):1998-2004 - https://www.nejm.org/doi/full/10.1056/NEJMsr1611785
5. Hudson KL, Lauer MS, Collins FS. Toward a new era of trust and transparency in clinical trials . JAMA; 2016 Oct4;316(13):1353-1354 - https://jamanetwork.com/journals/jama/fullarticle/2553888?guestAccessKey=554e0981 -9434- 45f2-b122-d0e673cd1182
6. Office of the Federal Register: Final Rule for Clinical Trials Registration and Results Information Submission (September 2016) - https://www.federalregister.gov/documents/2016/09/21/2016- 22129/clinical-trials-registration-and-results-information-submission
7. NIH Regulations - https://www.govinfo.gov/app/details/USCODE-2011-title42/USCODE-2011- title42-chap6A-subchapIII-partA-sec282
8. NIH Policy on Registration and Results Submission of NIH-Funded Clinical Trials -
https://www.federalregister.gov/documents/2016/09/21/2016-22379/nih-policy-on-the-
dissemination-of-nih-funded-clinical-trial-information
9. Requirements for Registering & Reporting NIH-funded Clinical Trials in ClinicalTrials.gov -
https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
International Policies
1. International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration Policy -
http://www.icmje.org/recommendations/browse/publishing -and-editorial-issues/clinical-trial-
registration.html
2. ICMJE Frequently Asked Questions - http://www.icmje.org/about-icmje/faqs/clinical-trials-
registration/
3. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals - http://www.icmje.org/recommendations/