Frequently Asked Questions

Do I need to register my clinical trial on

The UCSF Clinical Trials Registration & Reporting policy requires registration of all clinical trials (all phases and intervention types) in the 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.

What resources are available to learn about entering results? has the following resources to help researchers, which we strongly recommend that you review prior to entering results:

Conflict of Interest (COI)

COI - General

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). 

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

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.

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.

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