Tip of the Week Archive

May 6, 2021

FDA announced in a bulletin last week that it has issued its first Notice of Noncompliance to a responsible party of an Applicable Clinical Trial (ACT) for failing to submit required results data to ClinicalTrials.gov, and that it has issued more than 40 Pre-Notices of Noncompliance. You may be wondering if you or your group could be at risk for similar FDA enforcement actions. We’ve put together a quick Q & A to help.

Apr 29, 2021

FDA announced in a bulletin on April 28, 2021 confirming that it has issued its first Notice of Noncompliance to a responsible party for failing to submit required results data to ClinicalTrials.gov.

Apr 22, 2021

ClinicalTrials.gov records that are not “Completed”, “Terminated” or “Withdrawn” must be updated at least once every 12 months (we ask every 6 months while actively recruiting). If the record has not been updated in over a year, the system will flag the record with a problem status.

Apr 15, 2021

A Record Owner (i.e. the Principal Investigator) may want other study team members to be able to help edit and update the ClinicalTrials.gov study record. In these cases, the Record Owner can add them to the Access List for that record.

Apr 8, 2021

Review these sample plans for the Individual Participant Data (IPD) Sharing field.

Apr 1, 2021

ICMJE policy states that, in order to be eligible for publication in member journals, clinical trials must be registered on ClinicalTrials.gov PRIOR to the enrollment of the first subject.

Mar 4, 2021

The Adverse Events Time Frame is the specific period of time over which adverse event data were collected for each study participant. It is NOT the overall duration of the study during which adverse events were being collected for all participants.

Feb 25, 2021

ClinicalTrials.gov defines this field as indicating whether “a clinical study is studying a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act.”

Feb 18, 2021

An Outcome Measure described in a ClinicalTrials.gov record should be an individual variable or measurement used to assess the protocol outcome. If an Outcome Measure includes multiple measurements or variables, PRS will reject the record with the following comment: "Major Issues: More than one outcome measure appears to be described."

Feb 11, 2021

After a study record is completed by the study team, it is reviewed by a University administrator and released to ClinicalTrials.gov’s PRS staff for quality review. For registration submissions, PRS review usually takes 2-5 business days. For results submissions, PRS review can take up to 30 days.

Feb 4, 2021

ClinicalTrials.gov record owners (the study P.I. for CU investigator-initiated studies) are responsible for maintaining study records in compliance with federal regulations and University and institutional policies.

Jan 28, 2021

For University of Colorado Denver | Anschutz ClinicalTrials.gov records, the following should always apply: 1) The Principal Investigator is the Record Owner; 2) The University is the Sponsor and Responsible Party.

Jan 21, 2021

The Adverse Events module summarizes SAEs and AEs that are collected during the study in a table.

Jan 14, 2021

If you are using a score or a scale as an Outcome Measure, you must include specific information about the score or scale in the Outcome Measure Description on ClinicalTriasl.gov.

Jan 7, 2021

The results data that need to be reported to ClinicalTrials.gov are probably simpler than you think! Only four modules of simple data are required, and step by step guided tutorials are available to take you through the process.

Dec 17, 2020

Users of the public-facing ClinicalTrials.Gov site can now use the Advance Search function to search for study records with Food and Drug Administration Amendments Act of 2007, Section 801 (FDAAA 801) Violations.

Dec 10, 2020

When you enter your results data that you collected for your outcome measures into the Outcome Measure Data Tables, you’ll need to specify a “Measure Type”. The Measure Type is the type of data (e.g. count of something, mean value, etc.) for the outcome measure. It might even be specified in your Outcome Measure title or description.

Dec 3, 2020

When you enter your results data into your Outcome Measure Data Tables, you’ll need to specify the Unit of Measure for your reported data. The Unit of Measure is what is quantified by the data you entered in the Outcome Measure table (e.g., participants, mmHg).

Nov 25, 2020

Here are some common reminders and tips for using ClinicalTrials.gov.

Nov 19, 2020

Aims/Objectives in a protocol are sometimes confused with outcome measures. However, if an aim or objective is entered into ClinicalTrials.gov as an outcome measure, this can lead to the record being rejected during QC review. Therefore, it’s important to understand the differences between aims/objectives and outcome measures.