The International Committee of Medical Journal Editors (ICMJE) policy compels its member journals to require that clinical trials be registered on ClinicalTrials.gov before enrollment of the first participant as a condition of consideration for publication.
For CU ClinicalTrials.gov records, the Record Owner should always be the P.I. However, the Record Owner defaults to whomever registers the record. If the Record Owner is incorrect, contact firstname.lastname@example.org to change it.
NIH policy requires investigators/awardees to ensure that clinical trials are registered and that results information is submitted to ClinicalTrials.gov if 1) the clinical trial is funded in whole or in part by NIH; and 2) the grant application was submitted on or after January 18, 2017; and 3) the funded clinical trial was initiated on or after January 18, 2017.
If the record does not meet ClinicalTrials.gov's QC criteria, PRS will reject the record and add specific comments related to the problems identified. In these cases, the record will be flagged with the "PRS Review Comments" problem status.
Whenever you update a ClinicalTrials.gov record, you must click the green "Entry Complete" button when you are finished. Until the button is clicked, the record will show the "Entry Not Completed" and "Update Not Released" problem statuses.
As of January 25, 2022, the P.I. must make the decision to close a slow-enrolling or paused study and submit a delay request before the results would have been due, i.e., before 1 year after the Primary Completion Date.
All IRB-approved study sites should be added to the study record. Ensuring that all study sites are added to your record is a great way to help potential participants find enrolling locations near them.
ClinicalTrials.gov records need to be resolved before a P.I. leaves their position at CU. If records are left unresolved, it puts the University at risk for noncompliance, and burdens other researchers and study team members with the tasks of tracking down the unreported data or contacting the P.I. at their new position.
An Applicable Clinical Trial or ACT is a certain type of drug, biologic, or device trial that is required by U.S. law to be registered on ClinicalTrials.gov, and to have basic results data submitted there within 1 year of the primary completion date.
The first beta release of the new, modernized version of ClinicalTrials.gov's public facing website is now available at https://beta.clinicaltrials.gov/. Only the beta of the public facing website is available right now. The beta modernized PRS system (i.e. the register.clinicaltrials.gov site used to register studies and enter results) is planned to launch in early 2022.
ClinicalTrials.gov's PRS Review staff conduct a quality control review every time a record is registered or updated and released for publication. If the record does not meet their quality control criteria, they may issue one of two types of QC "comments": "Advisory" or "Major Issue".
Take a look at the Example Studies for Results Data Entry available on the ClinicalTrials.gov Training Materials webpage. These fictional study records show key concepts for registration and results data entry for various study designs.
YES!!! Although it is vital to ensure that your study is registered correctly prior to beginning enrollment, your record is a living document, and should be kept up to date according to the current study status and the study protocol. Update and edit it early and often!