Page 331 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE
Acronyms
Children’s Health Research Administration – CHRA Children’s Health System of Texas - CHST
Research Administration SOP No: R-Rec-002
SOP Title: Advanced Analytics: Screening & Data Reports
Children’s Health -Children’s Health System of Texas (CHST)- Children’s Health Clinical Operations (Complex Care, AFC, CHPG, DPMSC,CMCD, CMCP, OCH)
Principal Investigator – PI
Primary Research Coordinator – PRC Primary Administrative Coordinator – PAC Quality Specialist – QS
Data Intelligence Group – DIG Performance Site Approval – PSA
1. PURPOSE
For researchers seeking assistance from Children’s DIG for clinical data extraction services, the purpose of this Standard Operating Procedure (SOP) is to describe the process of tracking requests, verifying data request elements matches approved protocol, identifying funding source, finalizing funding agreement before approving to release data to the researcher.
2. DEFINITIONS
Children’s Health Research Administration will only approve data requests when those requests:
1. aresubmittedthroughtheapproveddatarequestprocessdescribed below;
2. ForIRBapprovedresearchprojects:assignedQSmembertoverify data element request matches IRB approved protocol data elements. A DIG Time Estimate is needed for data extraction and a funding source needs to be identified to cover the $75.00 hourly service charge. Documentation of funding (e.g. SOA, SOW) needs to be in place prior to data release;
3. Forfeasibilityrequests:assignedQSmemberneedstoverifyrequest is for aggregative/anonymized data. There is no charge for feasibility requests.
4. ForPreparatorytoResearch:assignedQSmemberneedstoverify that researcher has signed The Preparatory to Research Attestation