Page 335 - 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
2. DuringIRBreview,studyteamwillensuretheirdatarequestedintheirProtocol (Form A), HIPAA Waiver (Form H), and their data collection form (Form J) all are congruent.
3. ForDataRequests,studyteamwillsubmitaDataRequestandacopyoftheir data collection form to:
https://dallaschildrens.sharepoint.com/teams/dig/request/Lists/Research%20Req uests//EditForm.aspx
The study team will choose the request type as either:
a. Feasibility – (Define here): aggregate data without identifiers / PHI
– no IRB approved study - (TBD)
b. Preparatory to Research – (Define here): for some PHI, escalate to DAT / VB – no IRB approved study - (TBD)
c. Estimation of time needed - to determine the time needed to build the data extraction report – for all IRB-approved study data requests.
4. PI/PRC/PACwillbeavailabletoaddressanyquestionsthatarisefollowing initial review by both DIG and the CHRA QS.
5. PI/PRC/PACmayseeandtracktheirrequestsat: My Requests (Audience: Everyone)
https://dallaschildrens.sharepoint.com/teams/dig/request/SitePages/My%20Rese arch%20Requests.aspx
IRB Approved Projects, Data Time Request – Example #01