Page 334 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-002
SOP Title: Advanced Analytics: Screening & Data Reports
viii. Once the SOA or SOW is fully executed, PSA can be completed and the data may be released to the study team.
d. IftheRequestorisrequestingmoredatathanisIRBapproved:
i. The QS will check the box next to ‘Approved with stipulations’ and
in the ‘Comments’ box, explain what stipulation / modification is needed, and submit the update. The Study Team is notified to update their documents.
ii. When a mod to the IRB to amend the approved data is approved, QS will confirm the updated IRB documents and will compare with the data request, adding a comment that the IRB documentation has been updated and the data request is approved.
iii. Once the QS approves the updated data request, the data request moves into the Advanced Analytics queue for estimation of time.
iv. If the time estimate is more than 1 hour, a charge of $75.00 per hour will be implemented.
v. Funding source for the charge will be confirmed by the QS and the Study Team.
vi. A SOA or SOW will be initiated to document the charge.
vii. Once the SOA or SOW is fully executed, PSA can be finalized
and the data may be released to the study team
e. IfthetitleordatabeingrequesteddoesnotmatchtheIRB-approvedstudy
or other major incongruencies exist in the request, QS may ‘Decline’ the request until the accurate details can be provided in the data request.
For Feasibility / Preparatory to Research requests:
1. Feasibility queries follow the same submission process. There is no fee for feasibility (i.e., aggregate data) queries.
(More Details to follow)
4.2 PI, PRC, PAC
1. DuringPerformanceSiteApprovalprocess,studyteamwillconfirmthatdata analytics / data intelligence group’s assistance is required to extract data for the study.