Tip of the Week Archive

Apr 14, 2022

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.

Mar 31, 2022

Principal Investigators (PIs) of clinical trials funded by the VA's Office of Research and Development (ORD) are responsible for registering and submitting results to ClinicalTrials.gov.

Mar 24, 2022

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 clinicalresearchsupportcenter@ucdenver.edu to change it.

Mar 17, 2022

Applicable Clinical Trials (or "ACTs") are trials that are required by federal laws and regulations to be registered on and have results data reported to ClinicalTrials.gov.

Mar 10, 2022

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.

Mar 3, 2022

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.

Feb 24, 2022

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.

Feb 17, 2022

If an Outcome Measure includes multiple measurements or variables with different units of measure, PRS will reject the record.

Feb 10, 2022

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.

Feb 3, 2022

Several conditions must be satisfied before a ClinicalTrials.gov record can be considered "closed".

Jan 27, 2022

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.

Jan 20, 2022

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.

Jan 13, 2022

ClinicalTrials.gov records are living documents, and should always be kept up to date with the protocol and current study information. Follow these steps to sign in and update your records.

Jan 6, 2022

Use this QC review-proof template to write an Outcome Measure Description that includes a Score or Scale.

Dec 16, 2021

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.

Dec 9, 2021

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.

Dec 2, 2021

If you need a University of Colorado Denver | Anschutz ClinicalTrials.gov account, contact clinicalresearchsupportcenter@ucdenver.edu. Do not reach out to ClinicalTrials.gov directly.

Nov 18, 2021

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".

Nov 11, 2021

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.

Nov 4, 2021

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!