Tip of the Week Archive

Oct 28, 2021

ClinicalTrials.gov got you SPOOKED? Don’t worry! There are plenty of ways to get help with your ClinicalTrials.gov questions:

Oct 21, 2021

The Baseline Characteristics Module is part of the Results section of the ClinicalTrials.gov record, and includes aggregate participant demographics information, as well as study-specific baseline measurements, if applicable.

Oct 14, 2021

In general, your goals will be: 1) To report all Outcome Measures that are listed as Primary or Secondary Outcome Measures in the protocol, and 2) To explain any discrepancies between the initial registration and current Primary and Secondary Outcome Measures, to avoid the appearance of reporting bias.

Oct 7, 2021

Observational studies do not meet the FDA, NIH, or ICMJE definitions of clinical trials, and are not required by these organizations to be registered on ClinicalTrials.gov, but should you register anyway? There are a few reasons you might want to consider registering an observational study.

Sep 30, 2021

The Sponsors and Collaborators module is part of the Protocol section of your ClinicalTrials.gov record. There are two required fields and one optional one. Here is how to fill them out for CU records.

Sep 23, 2021

Looking for an old ClinicalTrials.gov Tip of the Week? Our previous Tips are all archived on our ClinicalTrials.gov Support Page!

Sep 16, 2021

The Notice marks several new developments in FDA’s enforcement ramp-up: 1) This is the first time the Agency has warned an individual investigator, rather than a drug maker. 2) This is the first time FDA has brought enforcement action related to a trial sponsored by an academic institution. 3)The Notice describes and refutes two common arguments from the Responsible Party/PI.

Sep 2, 2021

Whatever ClinicalTrials.gov questions you have, Clinical Research Support is here for you with answers and assistance!

Aug 26, 2021

It is important to keep your record up to date and current. Journal editors routinely check the audit history of the record, and changing your primary or secondary outcome measures at the end of the study can lead to difficulty in getting your manuscripts published (we’ve seen it happen!).

Aug 19, 2021

If you randomized something besides participants to each arm of your study, such as "Eyes" "Implants" or "Hips", use the "Type of Units Assigned" feature in the Participant Flow module to show how these participants and units experienced your study.

Aug 12, 2021

The Brief Summary is intended for a general public audience. It should avoid very technical language and be understandable to readers without a science or research background. The Detailed Description can be more technical.

Aug 5, 2021

In addition to the issuing of a Notice of Noncompliance, which remains permanently public, FDA is authorized to seek civil money penalties of up to $10,000 per day for failure to submit required information to ClinicalTrials.gov.

Jul 22, 2021

If you paused enrollment and study visits due to the COVID-19 pandemic, and then later decided that you would not resume the study, how should you handle the Primary and Study Completion Dates and results reporting?

Jul 15, 2021

If your clinical study is funded in whole or in part by a U.S. Federal Government agency (such as NIH), the grant number must be entered in the Secondary ID field, and the Funder must be entered in the Collaborators field.

Jul 8, 2021

Certain studies are required to be registered in ClinicalTrials.gov, either by federal regulations or by various policies.

Jun 17, 2021

When entering results data for crossover studies, Arms/Groups typically need to be presented one way when entered into the Participant Flow and Baseline Characteristics, and then another way when entered into the Outcome Measure Data and Adverse Events modules.

Jun 10, 2021

https://fdaaa.trialstracker.net is an online searchable tool developed by the Evidence Based Medicine DataLab at the University of Oxford. It publicly monitors compliance with the FDA Amendments Act of 2007 (“FDAAA”), which requires that Applicable Clinical Trials (ACTs) must report basic results within 12 months of the last visit by a study subject where data was collected for a primary study outcome.

Jun 3, 2021

The Clinical Research Administration Office at CU is currently undertaking a large-scale quality control review of ClinicalTrials.gov records. If you are a record owner (P.I.) of a record that meets certain criteria, we have contacted you to request some information. Based on the feedback we’ve received, we’ve assembled a quick FAQ for you.

May 20, 2021

The Study Completion Date is the date of the last study visit where data was collected for the Primary or Secondary Outcome Measures. The Primary Completion Date is the date of the last study visit where data was collected for the primary study Outcome Measures only. This will be the same as the Study Completion Date unless the last study visit for primary outcome data collection occurs before the last study visit where data is collected for secondary or other outcomes.

May 13, 2021

NIH requires investigators/awardees conducting clinical trials to ensure that these 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 application for funding (e.g. grant application) for the clinical trial was submitted to NIH on or after January 18, 2017; and 3) The clinical trial being funded was initiated on or after January 18, 2017.