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Tutorial: ClinicalTrials.gov: Registration and Results Submission Requirements
The NIH Intramural Research Program Protocol Navigation Training Program presents Rebecca J. Williams, Pharm.D., MPH, Lister Hill National Center for Biomedical Communications, National Library of Medicine
“ClinicalTrials.gov: Registration and Results Submission Requirements”
January 7, 2013
More than five years have passed since the FDA Amendments Act of 2007 (FDAAA) expanded the requirements for clinical trial registration to include the submission of summary results to ClinicalTrials.gov. Is your clinical protocol subject to the law and are you prepared to comply? In this seminar, Dr. Williams outlines FDAAA requirements and medical journal policies that require clinical trial registration as a condition of publication. She also provides practical tips and examples for registering protocol information and submitting results to ClinicalTrials.gov.