Page 206 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q007
SOP Title: UTSW Institutional Review Board MOD Approval Notification Process
1) Send an e-mail to the PI/PRC/PAC with the following approved template language:
“With the approval of MOD _____, will __________ have access to CMC PHI or collect/handle/share data that has CMC PHI? Yes or No”
2) Direct them to MSS or GME (see above) if the investigator indicates “Yes”.
3) Send them the following attestation statement to review and sign:
I, ________________, PI on IRB study # STU_________ entitled, “_____________________”, attest that _____________ will not view / access / collect / share / or otherwise be involved with Children’s Health patients or their PHI until she is fully credentialed and trained at Children’s Health.”
______________ __________ ___________, M.D. Date
They can attest with an e-mail reply or an e-signature. Please file their response in the “Research Department” mailbox under the MOD sub-folder.
B. CMC-MOD Submissions documenting non-personnel related modifications (Consents, Target Enrolment, Other, etc.):
• Move notifications to folder for 365 days and then archive according to CMC procedures.
C. CMC-MOD Submissions documenting protocol changes:
• All MOD submissions documenting changes to the protocol will need to be logged at the time of IRB submission.
• Detailed notes regarding nature of protocol update will need to be entered into the MOD tracker.
• Depending on the change, a CTCA re-determination as well as an update to the service order agreement (SOA) may be warranted, along with approvals from the Clinic Managers of any added ancillary services.
• QS team member or designee will reach out to the PI/PRC, identify the protocol update, and document whether a CTCA re-determination, any SOA updates, or additional ancillary approvals have been initiated.
SOP No. 6, Date: 4/19/16, Revised 5/31/16; 11/29/18; 02/17/21, 05/31/22