Download Form A (WIRB Eligibility Checklist)

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EMORY WIRB ELIGIBILITY
New Protocol Submission to WIRB
Study Information
Sponsor Protocol
Number:
Study Title:
Study Team Information
PI Name:
Coordinator Name:
WIRB Eligibility Determination
Please check your response to the following questions:
1. Is this research project involving human subjects designed to
evaluate prospectively the safety and/or effectiveness of new
drug(s) or device(s)?
Continue to Question 2.
YES
NO
2. Does the study full into one of the following categories?
a. Is this a Phase I Industry-Designed, Industry-Initiated and
Industry-Sponsored multi-center drug or equivalent device
research project? OR
b. Is this a Phase II Industry-Designed, Industry-Initiated and
Industry-Sponsored multi-center drug or equivalent device
research project? OR
c. Is this a Phase III Industry-Designed, Industry-Initiated and
Industry-Sponsored drug or equivalent device research
project? OR
d. Is this a Phase IV Industry-Designed, Industry-Initiated and
Industry-Sponsored drug or equivalent device research
project?
3. Is this an Investigator-initiated study and/or does the Emory
investigator hold the IND or IDE?
YES
Submit to eIRB for Emory
IRB review.
Continue to Question 3
NO
Submit to eIRB for Emory
IRB review.
YES
Submit to eIRB for Emory
IRB review.
Continue to Question 4
NO
4. Does any member of the research team have a financial
interest in this research project?
Yes
(See COI website for definition and reporting requirements.)
NO
5. Is the Atlanta VAMC or CHOA a participating site on this
research project?
YES
Submit to eIRB for Emory
IRB review.
Continue to Question 5
Submit to eIRB for Emory
IRB review.
Continue to Question 6
NO
6. Is the proposed research project co-sponsored by a federal
agency or non-profit organization?
YES
NO
Submit to eIRB for Emory
IRB review.
Submit to WIRB Listserv for
access to modified eIRB
submission.
**NOTE: The Emory IRB reserves the right to withhold any new research study from being sent to WIRB
Form A WIRB Eligibility Checklist
Last updated: September 27, 2016