Page 154 - CHST Research Administration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: R011
SOP Title: Data Requests at Children’s Healthsm
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. DIG request submitted after PSA is granted will be reviewed by a 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: