INDIANA UNIVERSITY HEALTH BLOOMINGTON INSTITUTIONAL REVIEW BOARD (IRB) Registration Form for Protocol Review by a Commercial IRB

The Principal Investigator (PI) must ensure that the protocol qualifies for review by a commercial IRB.

The proposed research protocol must be industry-sponsored, industry-written, and meet the National Institutes of Health definition of a clinical trial, which reads, “A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments or devices).”

The proposed research cannot involve planned emergency research, xenotranplantation, gene transfer, embryonic stem cell research, a Phase I/II pediatric population, waivers of informed consent or authorization, or be conducted at the VA Hospital.

Submit the following materials to the IUHB IRB Office:

. Registration Form for Protocol Review by a Commercial IRB . The research protocol . The proposed informed consent document using the external IRB template . HIPAA authorization form . CVs for all investigators that are to be listed on the Commercial IRB Initial Submission Form or the External Investigator Submission Form for Multi-Center Protocols Current document(s) on file with IU Health Bloomington IRB Office . Conflict of Interest for Investigator, Sub-Investigators & Study Team Current document(s) on file with IU Health Bloomington IRB Office . Human Subjects Training for Investigator, Sub-Investigators & Study Team Current document(s) on file with IUHB IRB Office . Initial IRB determination letter

. The Principal Investigator requesting the use of the commercial IRB will submit initial submission materials and subsequent study correspondence to the commercial IRB. . The commercial IRB will notify the PI of its decision and will provide the PI with copies of all regulatory documents. . Investigators are required per regulations to maintain copies of all study correspondence

If you have questions regarding IU Health Bloomington IRB policy and procedures, please contact the IU Health Bloomington IRB Office at (812) 353-2847.

08/13/2014 RR 406-B 1 INDIANA UNIVERSITY HEALTH BLOOMINGTON INSTITUTIONAL REVIEW BOARD (IRB) Registration Form for Protocol Review by a Commercial Institutional Review Board (IRB)

Please type only in the gray boxes. To mark a box as checked, double-click the box, select “checked”, and click “OK”.

Principal Investigator: Phone: Email:

Co-Investigators: Contact Information: Name: Address: Phone: Email:

Project Title: Sponsor: Protocol #: Synopsis of the research:

This study is being submitted to (name of central IRB) .

This protocol qualifies for review by a commercial IRB in accordance with the criteria below:

YES NO

1. Does this research meet the NIH definition of a clinical trial? (“A prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices.”)

2. Is the protocol designed and written by the sponsor?

3. Is the sponsor of the research a for-profit entity/company?

4. Is this an adult Phase II/III/IV multicenter clinical trial?

5. Is this a pediatric Phase III/IV multicenter clinical trial?

6. Is this the first time that this study has been submitted to the IU Health Bloomington or any other IRB?

** If any of the answers to questions 1 through 6 is “NO”, the protocol cannot be reviewed by an a central IRB. Submit to the Indiana University Health Bloomington IRB.**

08/13/2014 RR 406-B 2 Does the proposed research involve: YES NO

7. Planned emergency research?

8. Xenotransplantation?

9. Gene Transfer?

10. Embryonic stem cells?

11. VA Hospital?

12. Research funds from a federal or other not-for- profit funding agency?

13. Phase I/II pediatric research?

14. Waivers of informed consent?

**If any of the answers to questions 6 through 14 is “YES”, the protocol CANNOT be reviewed by a central IRB. Submit to the IU Health Bloomington IRB.**

Proposed research involves: YES NO Investigational drug(s) or devices, or investigational use of marketed drug(s). If yes, provide:

IND/IDE Number: Issued to: Generic Name: Radioactive drugs or external radiation exposure in addition to or beyond the standard

of care. Approval by the Radiation Safety Officer is required prior to initiation of the study.

The research meets the IU Health Bloomington IRB criteria for deferral to a commercial IRB as outlined above.

08/13/2014 RR 406-B 3 This form must be electronically signed by the Principal Investigator or designee. The electronic signature certifies that the information provided above is accurate, current and complete.

08/13/2014 RR 406-B 4