Page 355 - eBOOK VERSION 8 BOOK 2 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q022
SOP Title: Data Requests at Children’s Healthsm
2. During IRB review, study team will ensure their data requested in their Protocol (Form A), HIPAA Waiver (Form H), and their data collection form (Form J) all are congruent.
3. For Data Requests, study team will submit a Data Request and a copy of their 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 / PAC will be available to address any questions that arise following initial review by both DIG and the CHRA QS.
5. PI / PRC / PAC may see and track their requests at: 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