Page 245 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q013
SOP Title: Guideline for Revising SOAs Impacted by Modifications
6. TEMPLATE
Members of the Quality Specialist (QS) team who manage the Research Mailbox receive daily IRB MOD submission and approval notifications. For IRB MOD submissions that impact the study protocol, members of the QS team will review the protocol changes in detail and document the updates in a log. For those modifications that involve administrative or non-billable charges, the QS team member will simply note the change(s). However, members of the QS team will utilize a more detailed approach when addressing a protocol modification impacting billable charges. The following approach will be taken:
1. QS team member will review the MOD and create a brief summary report and whether a request for an SOA update is warranted:
IRB #
Provide IRB #
Velos#
Provide Velos#
PI
Provide PI name
Department
Pediatrics Vs. Non Pediatrics. For Non Pediatrics, provide name of department
PRC
Provide PRC Name
MOD#
Provide MOD #
Brief Summary of MOD
Describe billable changes – labs, visits, imaging, etc.
Protocol Track Change
Reference sections of the protocol where change is documented
CTCA
Provide a copy of the previously approved CTCA
Is an update to the SOA needed?
Yes / No / Possibly
Comments
2. Summary of findings will be provided to RA leadership (Deborah Town) to review.
3. RA leadership will make final determination and will direct QS team member to either
close the case or follow-up with the PI/PRC.
4. For those modifications that require engagement, QS team member will follow-up with
the PI/PRC and request for an update to the SOA. Members of the Finance Team (Nancy Reveles, Christina Lopez, Elizabeth Machado) will be copied in order to follow-up with the PRC regarding any new charges that need to be identified and pulled while updates to the SOA are being made.
5. QS team member will set an expectation of two weeks for the PI/PRC to submit the request for SOA update.
6. A follow-up e-mail will be sent to PI/PRC if compliance to bullet # 5 is not met. Follow-Up will be escalated to include Ms. Deb Town, and Ms. Brenda Paulson at two week intervals if action is not taken by the PI/PRC.
SOP No. 12, 12-20-2018