IRB Letter

IRB Approval Letter ID 21202-01.pdf

Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery

IRB Letter

OMB: 0910-0697

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November 4, 2021
Everly Macario, Sc.D, MS, Ed.M
IQ Solutions, Inc.
11300 Rockville Pike, Suite 901
Rockville, MD 20852
RE:

2021 FDA CTP Email Survey Audience Analysis Study
E&I ID# 21202

Dear Dr. Macario:
Using a Determination of Research with Human Subjects assessment process, the E&I
administrative review team has reviewed your submission. We have determined that your
project is not "research". No formal IRB review is required at this time. Please keep this
determination document with your project records.

E&I Assigned Study ID:
Date of Certification:

21202 - 01
November 2, 2021

Conditions: There is no expiration date. The determination does not render any opinion about
the ethical conduct of the activities. The determination is for the described activities only. If
there is a question about the determination, please call.
Please remember to submit any desired modification to your project for further assessment
and consideration prior to carrying out such changes.
Thank you for choosing E&I and please feel free to contact us anytime, we are here to help.
Sincerely,

Teresa Majors
Organizational Official
cc: Malini Runnells, [email protected]
Sarah Byrnes, [email protected]

E&I Business • 304 SE Third Street, Lee’s Summit, MO 64063 • (800) 472-3241


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