Page 294 - 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
identifiable data points (PHI, PII) in designing the protocol; no publication or presentation can be done under preparatory to research, and the data cannot be removed from Children’s Health and needs to be stored securely. For this type request, some PHI or other identifiers may be provided to the requestor.
• Advanced Analytics Research Request - This request is for IRB-approved studies or projects in the process of being approved by the IRB. For this request type, the requestor will solicit Children’s Advanced Analytic team to build a data extraction report based on IRB approved protocol. The data approved by the IRB will be the only data released.
• Self Data Pull Request - This request is for IRB-approved studies or projects in the process of being approved by the IRB. For these requests, the requestor will NOT NEED THE ASSISTANCE OF THE ADVANCED ANALYTICS TEAM. Only IRB-approved data can be released. There are three types:
A. IRB-approved study team member(s) will extract data from EPIC
B. Data Manager will extract data from a clinical database C. Report Writer will extract report
NOTE: Citation Policy: Any researcher who receives funding or research support of any kind from Children’s, including the use of data, must acknowledge the support in all publications, newsletters,
presentations, and posters by stating "Research reported in this publication was supported by Children’s HealthSM. The content is solely the responsibility of the authors and does not necessarily
represent the official views of Children’s HealthSM.” All publications must be registered with PubMed Central (PMC) immediately upon acceptance for publication, if accepted into a journal that automatically deposits in PMC.
3. DEFINITIONS
Children’s Health Research Administration will only approve data requests for release of data when those requests:
• Are submitted through the approved data request process described below;
SOP#23: 04/14/2020; 06/10/2020; 11/08/2020; 08/25/2021