Page 169 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q007
SOP Title: UTSW Institutional Review Board MOD Approval Notification Process
1) Sendane-mailtothePI/PRC/PACwiththefollowingapprovedtemplate language:
“Dear _______,
For your project, can you verify whether ____________ will require CMC credentialing? Alternatively,youcanreviewandsignthefollowingifs/hewill not require credentialing:
(for Studies with Waiver of Authorization)
“I,________________,___(PI, Co-I, PRC, FS, Other) listed on Velos XXXXX, STU-XXXX-XXXX, entitled, ‘__________,’ attest that a waiver of authorization is in place for this project and ________ will not access Children’s campuses or resources to meet with patients and their families or perform study related activities for this project.”
_______________________ ___________ PI Signature Date
(for studies with Authorization)
“I,_______________,__(PI, Co-I, PRC, FS, Other) listed on Velos XXXXX, STU-XXXX-XXXX, entitled, ‘__________,’ attest that an authorization to share research data with members of the research team is in place for this project and I will not access Children’s campuses or resources to meet with patients and their families or perform study related activities for his project.”
_______________________ ___________ PI Signature Date
2) DirectthemtoMSSorGME(seeabove)iftheinvestigatorindicates“Yes” credentialing is required.
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:
SOP No. 6, Date: 4/19/16, Revised 5/31/16; 11/29/18; 02/17/21; 08/24/21