Formative Research Support: Outcomes and Awareness Measurement Research

APPROVAL
March 16, 2022
Matthew Eggers
919-990-8380, x28380
[email protected]
Dear Matthew Eggers:
On 3/16/2022, the IRB reviewed the following submission:
Type of Review: Initial Study
Title: Formative Research Support: Outcomes and
Awareness Measurement Research
Investigator: Matthew Eggers
IRB ID: STUDY00021925
Funding Source: FDA Ctr Tobacco Products
Customer/Client Name: FDA Ctr Tobacco Products
Project/Proposal Number: 0217597.008
Contract/Grant Number: 75F40120A00017
IND, IDE, or HDE: None
The IRB approved the study on 3/16/2022. Any changes to the approved study protcol or
documents must be submitted to the IRB as a modification for review and approval prior
to implementation. Within 30 days of study completion, you should request to close the
study in IRB Express. You can submit a modification or study closure by navigating to
the active study and clicking Create Modification / CR.
In conducting this protocol, you are required to follow the requirements listed in the
Investigator Manual (HRP-103), which can be found by navigating to the IRB Library
within the IRB system.
Please be aware that before any research with human subjects can begin, the study team
is required to submit a modification to provide documentation that this FDA-CTP funded
study has in place an approved QMP. In this modification, the study team must: 1) revise
their response to Section 23 of the protocol template, to indicate that this FDA-CTP
funded study has a QMP; and 2) upload a scanned copy of the QMP signature page or
equivalent documentation of approval to the “Local Site Documents” section of IRB
Express.

Page 1 of 2

Sincerely,
The RTI Office of Research Protection

Page 2 of 2