Single IRB Request

I. PERSON COMPLETING THIS FORM

Name

Email

Phone

Tell us where you are in the process of your study:

II. PI / TEAM QUALIFICATIONS

Lead PI Name and Credentials

PI Email

PI Institution

Study Coordinator Name and Credentials

Study Coordinator Email

Co-Investigator(s) Name, Credentials, and Institution

III. TITLE AND FUNDING

Study title

Has your study been submitted to the VUMC IRB?

Please enter your Vanderbilt IRB#

Funding Source(s)

Is Vanderbilt the prime awardee?

Prime Award Site Name

Please provide a rationale why the prime site cannot serve as the Single IRB.

Are there funds allocated to cover SIRB review fees?

Please explain how SIRB fees will be covered.

IV. EXTERNAL SITE INFORMATION

How many external sites are involved in this study?

Please list all external sites

Sites not engaged in Human Subjects Research do not need to be listed.

Will all sites conduct the same study procedures?

If no, please explain.

V. STUDY INFORMATION

Provide a brief description of the research that includes the research question(s) and aim(s).

Is the study more than minimal risk?

What type of research is being conducted?

Total enrollment across all sites.

Type(s) of Study Sites (check all that apply)

Academic Institution/Medical Centers

Community-based Hospitals/Clinics

Non-research Institutions

Private Physician Practice/Groups

VA hospitals

Other

Please describe the other types of study sites

If other, please specify

Types of Research Activities (check all that apply)

Please upload a copy of the grant or protocol. If you do not have a protocol, please upload a summary or research plan.

If you are applying for a grant, please provide a copy of the grant.

If you have a template consent form, please upload that document here.

VI. DRUG / DEVICE INFORMATION

Does the study involve the use of a drug?

If yes, please provide the name of the drug.

Is there an Investigational New Drug (IND) application?

If yes, please provide the IND number.

Who is the IND holder?

Does the study involve the use of a device?

If yes, please provide the name of the device.

Is there an Investigational Device Exemption (IDE)?

If yes, please provide the IDE number.

Who is the IDE holder?

VII. CCC / DCC

Is there a Clinical Coordinating Center (CCC)?

If yes, state where the CCC is located.

Is there a Data Coordinating Center (DCC)?

If yes, state where the DCC is located.