Tip of the Week Archive

A federal court has ruled that FDAAA unambiguously requires responsible parties to submit Basic Results data to ClinicalTrials.gov for pre-Final Rule, pre-approval Applicable Clinical Trials. The ruling by a federal judge set aside a previous HHS interpretation of the Final Rule (42 CFR Part 11).

Responsible parties must now submit results data to ClinicalTrials.gov for any Applicable Clinical Trial (ACT) that:

1. was initiated after September 27, 2007, or was ongoing as of December 26, 2007;
2. reached its primary completion date (i.e. the last study visit where you collected data for your primary outcome) before January 18, 2017; and
3. studied a product that is approved, licensed, or cleared by FDA at any time, including after the ACT’s primary completion date.

Also, please note that:

• This ruling doesn’t negate the existing requirements for posting results for ACTs that were already interpreted to be required to post results under the Final Rule or FDAAA 801.
• If the product studied in the ACT is not currently approved, licensed, or cleared by FDA, but is at a future date, then the results data must be submitted within 30 days after the date that the product is approved, licensed, or cleared by FDA.
• For Applicable Clinical Trials, results data must be posted to ClinicalTrials.gov whether the trial concluded according to the protocol or was terminated prematurely within one year of the primary completion date.

What does this mean for CU Responsible Parties?

It means that if you are a Record Owner for any ClinicalTrials.gov records, even for older studies, you should log into ClinicalTrials.gov and review your records to verify whether you need to submit results.

ClinicalTrials.gov’s PRS system treats these “probable Applicable Clinical Trials” or “pACTs” identically to post-Final Rule ACTs when flagging records for required results submission. If results for a pACT are overdue, you would currently see a ‘Late Results per FDAAA’ problem message on the record.

The Clinical Research Support Center also treats pACTs just like ACTs. Record Owners with “Late Results” for pACTs are notified of their status by the PRS administrator and prompted to submit results data.

To view your ClinicalTrials.gov records and check whether your study is a pACT/ACT:

• Log in to Clinicaltrials.gov at https://register.clinicaltrials.gov/. Your user name is your institutional email and the organization is UColorado
• You’ll see a list of your records after logging in. Those with Late Results will display a “• Late Results - per FDAAA” message in the “Problems” column
• Open your record by clicking the “Open” link
• The Record Summary page will display whether your trial is an “ACT”, a “probable ACT” or “Non-ACT” in the FDAAA field. For studies required to submit results, the deadline for results submission will also be displayed. Refer to the screenshot below:

The Clinical Research Support Center is here to help!

If you need assistance submitting results, accessing your records, or understanding the requirements for your studies, contact clinicalresearchsupportcenter@ucdenver.edu. We will work with you and your team to answer your questions and help you bring your record back into compliance.