UCSF - Clinical and Translational Science Institute

RKS SERVICE REQUEST

The Regulatory Knowledge and Support Service (RKS) provides consultation and regulatory guidance for clinical and translational research. Request an RKS consultation by completing the form below.

If you are a UCSF researcher or a CTSI affiliate, you can request a consultation by completing the form below. Fields marked with an asterisk are required. If you have not been contacted by a member of the RKS consulting team within three business days of submitting your request, email marlene.berro@ucsf.edu or call us at: 415-476-3426.

Important: all publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH Funding acknowledgement.

Information about you

First Name*

Last Name*

Email*

Phone

Mailbox

The information we're requesting below helps us understand your needs better and captures who we are serving. Thank you in advance for completing and submitting this form.

Degrees (check all that apply)

MD PhD MCR/MPH/MS DDS RN PharmD Other

Faculty Rank

Faculty Series

Non-faculty Title

If other, please specify

School (primary)*

Campus

If other, please specify

Department (primary affiliation)*

If other, please specify

Division or research unit, if applicable

Time spent on research

Time spent in clinic

Primary research type*

If other, please specify

Gender

Ethnicity

Race

Project Information

Title/Topic*

Grant Deadline/Study Start Date*

Sponsor/Source of Funding

Specify Name of Funding Source

Stage of Project (check one)

Planning study
Applying for funding
Implementing funded study
Responding to reviews
Other/Unsure:

Types of Regulatory Consultation Needed (Check all that apply)

UCSF

Committee on Human Research (CHR)
Institutional Animal Care and Use Committee (IACUC)
Radiation Safety Committee (RSC)
Biological Safety Committee (BSC)
Use of human stem cells
HIPAA
Conflict of Interest Advisory Committee (COIAC) Conflict of Interest Forms
Industry Contracts
Controlled Substances

FDA

Investigational New Drug application (IND)
New drug application (NDA) or biological license application (BLA0)
Investigational Device Exemption (IDE)
Drug development related regulations and program design
Other FDA questions

Yes	No	Unsure
			Does this project support an application to the FDA for non-clinical laboratory studies? (Title 21 CFR Part 58)?
			Is this a drug development study?
			FDA IND or IDE Required (please check if unsure)

Anticipated Level of Assistance (Check all that apply)

Simple advice (probably single session)
Complex advice (probably multiple sessions)
Other/Unsure:

RKS SERVICE REQUEST

Information about you

Project Information

Types of Regulatory Consultation Needed (Check all that apply)

Anticipated Level of Assistance (Check all that apply)

Survey If available, what additional consultation services would be needed? (Check all that apply)

Other Comments