Page 297 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q022 SOP Title: RESERCH DATA REQUESTS AT
CHILDREN’S HEALTHsm
request, adding a comment that the IRB documentation has been
updated and the data request is approved.
(3) If the title or data being requested does not match the IRB-approved
study or other major incongruencies exist in the request, QS may ‘Decline’ the request until the accurate details can be provided in the data request.
4.2 PI, PRC, PAC RESPONSIBILITIES
1. During Performance Site Approval process, study team will confirm that Advanced Analytic’s assistance is required to extract data for the study.
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) are congruent.
3. For all research Data Requests, study team will submit a Data Request and a copy of their protocol (if any), HIPAA Waiver Form H and Form J, data collection form to:
https://dallasc hildre ns. sh arep oint .c om /team s/d ig/r equ est /Li sts /Res earc h%2 0 Requests//EditForm.aspx
The study team will choose the request type as either:
a. Feasibility – aggregate data without identifiers / PHI – no IRB approved study
b. Preparatory to Research – for some identifiers / PHI – no IRB approved study
c. Advanced Analytics Research Request – for data congruent with IRB approved protocol, Forms H & J
d. Self Data Pulls – to obtain permission for study personnel or department database managers who will extract the IRB-approved data from the department databases / EPIC / or other databases – for IRB- approved studies.
4. PI / PRC / PAC will complete the data request and submit it for review.
5. PI / PRC / PAC will be available to address any questions that arise following
initial review by both DIG and the CHRA QS.
6. PI / PRC / PAC may see and track their requests at:
https://dallasc hildre ns. sh arep oint .c om /team s/d ig/r equ est /SiteP age s/M y %20R esearch%20Request
SOP#23: 04/14/2020; 06/10/2020; 11/08/2020; 08/25/2021