Does your trial need to be registered and have results reported?
The Food and Drug Administration (FDA) requires study registration along with results and adverse event reporting for all phase II - IV interventional drug, biologic or device trials ("applicable clinical trials"). Failing to register or report results for "applicable clinical trials" in a timely manner can result in significant monetary penalties. For additional information on the FDA's registration requirements, please download the National Institutes of Health's Elaborations of Definitions of Responsible Party and Applicable Clinical Trial.
Publication of interventional health outcome studies in journals adhering to the International Committee of Medical Journal Editors' (ICMJE) Uniform Requirements for Manuscripts Submitted to Biomedical Journals is contingent on timely study registration. The ICMJE does not currently require results reporting. For additional information on the ICMJE's registration requirements, please visit the ICMJE's Clinical Trials Registration website.
If you have questions about the application of the FDA and/or ICMJE registration requirements, please contact Ryan Moze using the information at the bottom of this page.
Additionally, the Center for Medicare & Medicaid Services (CMS) requires the registration of most studies billing third parties for study related services. For more information on the CMS requirements, contact Nancy Lutz, UW Health Research Compliance Billing Program at email@example.com.
Are you responsible for trial registration?
The study sponsor is generally responsible for trial registration and the sponsor must register all industry-sponsored trials.
However, the UW-Madison investigator is responsible for registration when one or more of the below conditions are met:
For additional information on the responsibility for trial registration, please download the National Institutes of Health's Elaborations of Definitions of Responsible Party and Applicable Clinical Trial.
When do you need to register your trial?
The FDA requires that all "applicable clinical trials" be registered within 21 days of the first subject's enrollment. The ICMJE requires trials to be registered prior to the first subject's enrollment.
However, the ClinicalTrials.gov registration process can involve multiple rounds of quality assurance comments from the ClinicalTrials.gov staff, so UW-Madison recommends beginning the registration process as soon as your study has been approved by the IRB. For additional information on the quality assurance review process, please download the FDA's ClinicalTrials.gov Protocol Review Criteria.
When do you need to report results for your trial?
The FDA requires that the results of "applicable clinical trials" be reported within 12 months of the last subject's last study visit, which should be listed in ClinicalTrials.gov as the study's "primary completion date." Failing to properly update the "primary completion date" during the study may lead the FDA to believe that results should be posted before the study is actually completed. For additional information on the "primary completion date" within in ClinicalTrials.gov, please see ClinicalTrials.gov Data Element Definitions.
If you are registering a cancer-related study that requires review by the UW Carbone Cancer Center (UWCCC) Protocol Review & Monitoring Committee (PRMC), please contact firstname.lastname@example.org before registering.
The University of Wisconsin is registered as an institution at ClinicalTrials.gov and has appointed ClinicalTrials.gov administrators to assist UW-Madison investigators or their designees in establishing their ClinicalTrials.gov accounts. To request a user login, send an email message to your assigned ClinicalTrials.gov administrator (see below) with your name, department, email address, and telephone number. You will then receive an email with a login name and a temporary password that will allow you to register your protocol.
For cancer-related protocols, contact:
For a step-by-step explanation of how to register your study, visit ClinicalTrials.gov's website on How to Register Your Study. And for an explanation of the data fields within ClinicalTrials.gov, visit ClinicalTrials.gov's website on Data Elements Definitions.
Please complete the below data elements within ClinicalTrials.gov, as follows:
Once your trial is registered, the FDA requires that your ClinicalTrials.gov record be updated within 30 days of a change in recruitment status or completion date. Additionally, your Record Verification Date needs to be updated at least every 12 months and updated with any protocol changes that have occurred since your last update. For a further explanation of how to update your record, visit ClinicalTrials.gov's website on How to Edit Your Study Record.
Reporting Results for Your ClinicalTrials.gov Record
Results reporting is only required for studies that meet the FDA registration requirements ("applicable clinical trials"). Results should not be reported when only the ICMJE registration requirements apply.
ClinicalTrials.gov has four results reporting modules:
For a step-by-step explanation of how to report results, visit ClinicalTrials.gov's website on How to Submit Your Results. ClinicalTrials.gov also provides a very helpful Pre-Submission Checklist for results reporting.
For questions concerning this website or clinical trials registration at UW-Madison, please contact:
Ryan Moze, Office of Research Policy at (608) 262-1703 or email@example.com
|Keywords:||ClinicalTrials.gov, "study registration", "trial registration," FDA, ICMJE, results registration||Doc ID:||34044|
|Owner:||Ryan M.||Group:||Office of the Vice Chancellor for Research and Graduate Education and Graduate School|
|Created:||2013-09-27 11:37 CST||Updated:||2014-11-19 08:56 CST|
|Sites:||Office of the Vice Chancellor for Research and Graduate Education and Graduate School|
|Feedback:||1 1 Comment Suggest a new document|