Page 332 - 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
statement prior to any data release that includes PHI. There is no charge for preparatory to research requests.
Children’s Health Research Administration will not approve data requests:
1. thatarenotrequestedthroughtheapproveddataanalyticsprocess;
2. withoutreviewbythedataanalyticsteamtoprovideantimeestimate
estimate (only for IRB approved projects with PSA request under
review or approved);
3. withoutreviewbytheQSteamtoconfirmdatabeingrequestedisIRB
approved or is requested for “feasibility” or “preparatory to research”
needs;
4. withoutfundingforthosestudiesthatrequiremorethananhourto
extract.
3. SCOPE
This SOP applies to all individuals conducting research at Children’s Health.
4. RESPONSIBILITIES
4.1 CHRA Quality Specialist
For IRB-approved studies:
1. DuringPerformanceSiteReview,assignedQSmemberwillverifywhether the researcher will require CMC DIG data extraction services. Data Requests submitted after PSA approval has been granted will be reviewed by an appointed Quality Specialist.
2. ForthoserequiringDIGservices,QSwillguidemembersofthestudyteam (PI, PRC, PAC) to submit a data request to: https://dallaschildrens.sharepoint.com/teams/dig/request/Lists/Research%20 Requests//EditForm.aspx
3. AnemailnotificationwillbereceivedintheResearch-DataRequestmailbox managed by the Quality Specialists. The subject line will reflect:
“Research request ___ submitted (Estimation of time needed: [short title]”.
4. Whentheemailisreceived,QSwillopenthedatarequestworkqueueat: https://dallaschildrens.sharepoint.com/teams/dig/request/SitePages/Researc h%20Work%20Queue.aspx and review each request.
5. Underthe“ResearchWorkQueue”,newrequestswillbelistedforreviewas seen in this screen shot: