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.
ClinicalTrials.gov records that are not “Completed”, “Terminated” or “Withdrawn” must be updated at least once every 12 months (we ask every 6 months while actively recruiting).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.
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.
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.
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."
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.
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.
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.
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.
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.
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.
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).
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.