Page 296 - 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
5. QS will review the Requestor’s submitted data request and:
a. Confirm the PI’s attestation; if it is missing; the database will send the
Requestor an email with the subject:
“Action required – Research request #___: Investigator Attestation (short title)”.
Before any further review is conducted, the Investigator must complete the attestation and submit it.
b. QS will create a folder in the sharedrive at Research Finance (\\childrens.med\depts\RESEARC\SHARE\CLINICAL RESEARCH)(X): Quality Specialists\Data Analytics Requests with (PI name, STU#, DR#).
c. QS will confirm the inclusion criteria and data requested and compare it to the data included in the IRB-approved protocol (Form A), HIPAA waiver (Form H), and data collection form (Form J). QS will fill out the DIG Request Evaluation Form (see Appendix A) and place it in the PI’s folder in the sharedrive.
d. If data requested by the Requestor matches each IRB-approved data point:
i. QS will check the box next to ‘Approved’ and submit it for AA’s review and approval and/or creation of data requested.
ii. An email will be sent to the ‘Research-DataRequest’ mailbox with the subject line:
“Approved – Research request #___ (Self data pull: [short title])”
iii. The request will then move into the Advanced Analytics queue for review and creation of the data report.
iv. Once the AA team has created the report, the IRB approval is obtained, and the PSA is granted, the data may be released to the study team.
e. If the Requestor is requesting more data than is IRB approved:
(1) The QS will check the box next to ‘Approved with stipulations’ and in
the ‘Comments’ box, explain what stipulation / modification is needed, and submit the update. The Study Team is notified to update their documents.
(2) When a mod is submitted to the IRB to amend the approved data, QS will confirm the updated IRB documents and will compare with the data
SOP#23: 04/14/2020; 06/10/2020; 11/08/2020; 08/25/2021