Archived Announcements
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.
August 2020
Are you planning to submit a proposal for an animal study on or after October 1? Ensure that your application aligns with the AVMA Guidelines for the Euthanasia of Animals: 2020 Edition.
Are you up to date with the 2016 simplified criteria for the VAS of your NIH application? The Office of Laboratory Animal Welfare has released an online training module to help researchers and reviewers recognize what components are and are not required.
Latest Office of Research Town Hall Meeting from July 29, 2020 (Meeting Information, Video Archives, Q&A)
July 2020
NEW UCSF Health Guidelines for Expanded Use of Eye Protection & PPE Reuse Guidelines:
Effective immediately, in addition to universal masking, we recommend expanded use of eye protection (e.g., eye shields, face shields, or safety glasses) for ALL direct, close patient encounters in the clinical care environment.
In order to extend the use of your clinic supply of eye protection, review and practice the attached PPE Reuse Guidelines. If your clinic has not received eye shields or face shields OR your clinic needs additional eye or face shields based on preferences, please utilize the following material services contacts. For a satellite location, contact Jake Limbert directly for delivery or pick up.
- Parnassus: Fred Mejia, 3-1837
- Mission Bay: Fred Pique, 6-1116
- Mt. Zion: Marin Ivesic, 5-7255
Please review, post and implement with all Providers and staff in your practices. Supplies are available in the BearBuy COVID store for free.
Direct questions to Shirley Kedrowski or Morgan Crow.
June 2020 - Return to Work Guidelines & Operation Protocols
- Resumption of Research Activity Plan - Before your staff returns to work, DoS requires that the completion of a survey(s) laying out your clinical or laboratory plan. If you have both clinical research staff AND laboratory-based staff, you are required to complete surveys. Please email the Research Administration Team for access to the surveys and with any questions.
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Campus and Health Supply Chain Management, EH&S, and EOC have teamed up to implement the WE CARE program that provides a care package for all returning research and clinical labs. The package includes gloves, face coverings, hand sanitizer, and other items for safety. To receive a delivery of care packages for you and members in your lab, please complete the survey (note, only one survey is needed for each working unit).
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If you have a more urgent, acute need for PPE materials not met by the WE CARE package. Please email Emergency Management and they will do their best to facilitate your request.
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