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Important Research Infrastructure Announcements

Latest COVID-19 News and Resources

October / November 2020

  • UCSF Department of Surgery Scientific Writing Course - Winter 2021
    • To apply for the course please complete the application and submit a writing sample by Dec 1, 2020 to Pam Derish.
  • Message to the UCSF Clinical Research Community from the UCSF Office of Ethics and Compliance Regulatory Support Team's second edition of their newsletter (link to sign up for their newsletters and  archive).

Frequently Asked Questions

1) Am I required to submit results on ClinicalTrials.gov?

Yes, results reporting is required if your study is:

A clinical investigation of an FDA-regulated product. Otherwise known as an Applicable Clinical Trial (ACT) or Probable Applicable Clinical Trial (pACT) per FDAAA. (For complete definitions of Applicable Drug and Applicable Device Clinical Trials, see the ACT checklist and FAQs); or,

A NIH funded clinical trial (NIH Clinical Trial Requirements for Grants and Contracts); or,

Funded by a grant agency that requires results reporting on ClinicalTrials.gov (e.g., PCORI).

2) When do I have to submit results? ­­­­

Results must be submitted no later than 12 months after the Primary Completion Date. For more details see FDAAA 801 and the Final Rule: When Do I Need to Submit Results.

On average, it takes 21 days for ClinicalTrials.gov Protocol Registration and Results System (PRS) to review results. Accordingly, we recommend submitting results at least 60 days in advance to allow time for the review cycle process.

If PRS returns results with review comments, major issues must be addressed and results resubmitted for another review cycle which will take an additional 21 days.

If results do not pass the PRS review by the date results are expected, it will be flagged as Late Results – per FDAAA on ClinicalTrials.gov and may appear on the FDAAA Trials Tracker website.

3) What resources are available to learn about entering results?

ClinicalTrials.gov has the following resources to help researchers, which we strongly recommend that you review prior to entering results:

ClinicalTrials.gov PRS Results Reporting Guided Tutorial

ClinicalTrials.gov Results Quality Control Review Criteria

PRS provides Example Studies for Results Data Entry

4) What happens if I don’t submit results by the expected date?

FDA may seek civil money penalties for results reporting noncompliance under the Federal Food, Drug, and Cosmetic Act. NIH may withhold future grant funding.

5) Can I delay results reporting?

Sometimes, in very limited circumstances:

An extension request may be submitted for good cause. A pending publication is not an acceptable reason to delay results reporting.

A responsible party may delay the submission of results by submitting a certification to “Certify Initial Approval” or “Certify New Use” (this extremely is rare for non-industry study records).

Contact us for assistance with submitting an extension request or certification.

If you are a researcher affiliated with the Helen Diller Family Comprehensive Cancer Center, please contact Julie Robbins for assistance with results reporting on ClinicalTrials.gov.

Please reach out to us if you have any questions regarding ClinicalTrials.gov. We are always happy to help.

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