Page 170 - 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
• 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.
7. PROCESS MAP
Sta rt
Is study team
member credentialed
in Provider Lookup, or No
seen in Cornerstone as active?
Yes
Any
d efi ci enc ie s?
No
Yes
RQS
Document research training on Clinical Research Training spreadsheet as needed
RQS
Review the study staff approved by IRB for credentialing and training completions, note any deficiencies
RQS
UsingOutlook, determine if study staff is UTSW or CH em pl o ye e
For Medical Student: Peds .Clerkship@childrens.com
RQS
Use Cornerstone and Clinical Research Training spread sheet to verify completion of training
c ou rs es
For Fellows and Residents: Graduate Medical Education Office Medical_Education@childrens.com
RQS
Contact appropriate d ep art me nt
RQS
Contact Principal Inves ti gator, Rese arc h Coordinator or study team member
For Research Staff and Faculty: Medical Staff Services Credentialing & Privileging CVO@childrens.com
For general Clinical Education q ue sti on s:
SR. Affiliation Specialist
End
SOP No. 6, Date: 4/19/16, Revised 5/31/16; 11/29/18; 02/17/21; 08/24/21