Page 352 - 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
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. that are not requested through the approved data analytics process;
2. without review by the data analytics team to provide an time estimate
estimate (only for IRB approved projects with PSA request under
review or approved);
3. without review by the QS team to confirm data being requested is IRB
approved or is requested for “feasibility” or “preparatory to research”
needs;
4. without funding for those studies that require more than an hour to
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. During Performance Site Review, assigned QS member will verify whether 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. For those requiring DIG services, QS will guide members of the study team (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. When the email is received, QS will open the data request work queue at: https://dallaschildrens.sharepoint.com/teams/dig/request/SitePages/Researc h%20Work%20Queue.aspx and review each request.
5. Under the “Research Work Queue”, new requests will be listed for review as seen in this screen shot: