Frequently Asked Questions
ClinicalTrials.gov
Do I need to register my clinical trial on ClinicalTrials.gov?
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?
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?
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?
I have questions regarding how to complete my State of California form 700U disclosure.
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?
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?
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?
How do I find the FDA cleared/approved indications for the device I plan to use in my study?
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?