Page 333 - 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
6. QSwillreviewtheRequestor’ssubmitteddatarequestand:
a. ConfirmthePI’sattestation;itismissing;thedatabasewillsendthe
Requestor an email with the subject:
“Action required – Research request #___: Investigator Attestation (short title)”.
Before any further review is conducted, the Investigator must complete the attestation and submit it.
b. Confirmtheinclusioncriteriaanddatarequestedandcompareittothe data included in the IRB-approved protocol (Form A), HIPAA waiver (Form H), and data collection form (Form J).
c. If data requested by the Requestor matches each IRB-approved data point:
i. QS will check the box next to ‘Approved’ and submit it for DIG estimate of time required.
ii. An email will be sent to the ‘Research-DataRequest’ mailbox with the subject line:
“Approved – Research request #___ (Estimation of time needed: [short title])”
iii. The request will then move into the Advanced Analytics queue for review and an estimation of time needed will be prepared.
iv. When the estimate of time is prepared by the Advanced Analytics team, they notify the Research queue of the time needed.
v. If the time estimate is more than 1 hour, a charge of $75.00 per hour will be implemented.
vi. Funding source for the charge will be confirmed by the QS and the Study Team.
vii. A Service Order Agreement (SOA) or Statement of Work (SOW) will be initiated to document the charge.