Frequently Asked Questions
ClinicalTrials.gov
Do I need to register my clinical trial on ClinicalTrials.gov?
The UCSF Clinical Trials Registration & Reporting policy requires registration of all clinical trials (all phases and intervention types) in the ClinicalTrials.gov Protocol Registration and Results System (PRS) before enrollment of the first subject. The UCSF policy complies with the Food and Drug Administration Amendments Act (FDAAA), National Institutes of Health (NIH), International Committee of Medical Journal Editors (ICMJE), and Center for Medicare and Medicaid Services (CMS) definitions of a clinical trial.
How do I determine whether my clinical trial is an Applicable Clinical Trial (ACT) subject to the Food and Drug Administration Amendments Act (FDAAA)?
How do I get help with ClinicalTrials.gov at UCSF?
How do I register my study on ClinicalTrials.gov?
What are the legal and institutional obligations for researchers regarding ClinicalTrials.gov?
What resources are available to learn about registering a study on ClinicalTrials.gov?
Can I register my Observational Study on ClinicalTrials.gov?
What are the ClinicalTrials.gov Completion Date definitions?
Am I required to submit results on ClinicalTrials.gov?
When do I have to submit results on ClinicalTrials.gov?
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
- The ClinicalTrials.gov Regulatory Support Team is available to assist with results reporting issues on ClinicalTrials.gov, including reviewing records before submission to PRS, and helping to address PRS review comments.
Conflict of Interest (COI)
COI - General
What are my responsibilities as a UCSF employee?
From what types of activities should I disqualify myself when I have a related financial conflict of interest?
May I hire my near relatives should they be qualified to fill a position at UCSF?
I am faculty and want to start a company OR begin a new financial interest/relationship with a company. Who do I talk to?
I am (non-faculty) staff and want to start a company or begin a new financial interest/relationship with a company. Who do I talk to?
I have a question regarding conflict of interest in clinical care that is not related to research.
I'm a faculty member and disclosed my conflicts in OATS (Outside Activity Tracking System) or COI-Smart, do these systems talk to each other?
Is there a training required for COI?
I don't see my question above, who do I contact?
COI - Research
Will a financial conflict of interest with the research preclude me from participating on a research project?
Holding a financial interest does not necessarily mean that a conflict exists. If a conflict is found to exist, the Conflict of Interest Advisory Committee (COIAC) attempts to manage and mitigate the conflict(s).
I need to disclose outside financial interests as they pertain to research I conduct. How do I disclose these interests?
Why did I receive an e-mail stating that I need to complete a COI-Smart disclosure?
I received an error message when attempting to complete my COI-Smart disclosure.
How often do I need to update my COI-Smart disclosure?
Can I have a financial interest with a private sponsor of my research?
The Conflict of Interest Advisory Committee (COIAC) reviews financial interests with a private sponsor of research on a case by case basis. Contact [email protected] with any questions. It is always best to be proactive in addressing potential conflict of interest issues (prior to engaging in the research or beginning the financial interest).
I have questions regarding how to complete my State of California form 700U disclosure.
The instructions for the 700U address many common questions regarding what should be reported. Please note that the 700U requires that you disclose personal financial interests with the sponsor in the previous 12 months. Funding/reimbursements that have been received through the University (i.e. sponsored research agreement) are not considered personal financial interests.
Export Control
What Are Export Controls?
What is an “export”?
Is there a UCSF policy on export controls?
Where can I find a list of export-controlled items?
Would a license be required for a foreign national to participate in University activities?
How can I maintain a fundamental research environment?
I’m giving a webinar/web conference on my research to be shared internationally. What do I need to know?
What is Publicly Available/Public Domain Information and how does it affect my research?
How do the export control regulations affect research using biological agents or toxins?
How do I ship a controlled item or commodity out of the United States?
What do I do if I’m receiving a pathogen from abroad?
FDA Regulatory Support
Do I need an Investigational New Drug (IND) to study an Food and Drug Administration (FDA) approved drug?
You DO need an IND to study an FDA approved drug UNLESS your study meets ALL of the following IND exemption criteria found at 21 CFR 312.2(b)(1):
(i) The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug;
(ii) If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product;
(iii) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 [FDA requirements for IRB review] and with the requirements for informed consent set forth in part 50 [FDA requirements for Informed Consent]; and
(v) The investigation is conducted in compliance with the requirements of §312.7 [no advertisement/marketing].
Additional resources regarding IND exemption can be referenced here.
Who may I contact to help me determine whether I need an IND to use a drug in my research?
I want to study a supplement (e.g., melatonin, probiotics, omega-3s, etc.) and its effect on a disease. Is my study eligible for an IND exemption?
No. Only lawfully marketed drugs are eligible for an IND exemption. While a dietary supplement is lawfully marketed, it is not marketed as a drug.
An IND application to FDA is required if a clinical investigation is intended to evaluate the dietary supplement's ability to diagnose, cure, mitigate, treat, or prevent a disease. Contact [email protected] for specific guidance.
What is FDA’s definition of a medical device?
What is an investigational medical device?
My study involves an investigational medical device. What do I need to do to get approval to conduct my study?
You will need to obtain Institutional Review Board (IRB) approval. We recommend that you review the Invesitgational Device Exemption (IDE) Overview to decide what type of regulatory determination you need to request in your IRB application. The IRB will review your application and make a device determination for your investigational medical device. Only the FDA or an IRB can grant IDE exemptions or Non-Significant Risk (NSR) determinations.
How do I find the FDA cleared/approved indications for the device I plan to use in my study?
FDA has a list of medical device databases available on their website. Depending on the risk of the device, it may have received a Premarket Approval (PMA), 510k clearance, or De Novo. We recommend using only part of the name of the device or the manufacturer to successfully search the databases.
Additional device resources can be referenced here.
Improper Foreign Government Influence
What are specific concerns about improper foreign government influence in research activities?
What are the requirements for booking and disclosing travel outside the United States for official UCSF business?
May a PI nominate a student for a research prize in another country, when the prize may or may not be funded by the government of that other country?
May a faculty member provide advice to an education or research institution located overseas?
May UCSF continue to co-host research symposiums with universities from other countries?
What should I do if the FBI visits my lab unannounced?