Page 293 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
Acronyms
Research Administration SOP No: Q022 SOP Title: RESERCH DATA REQUESTS AT
CHILDREN’S HEALTHsm
Advanced Analytics – AA
Children’s Health Research Administration – CHRA
Children’s Health System of Texas - CHST
Children’s Health -Children’s Health System of Texas (CHST) and its Affiliates (collectively)
Principal Investigator – PI
Primary Research Coordinator – PRC
Primary Administrative Coordinator – PAC
Quality Specialist – QS
Data Intelligence Group – DIG Performance Site Approval – PSA
1. INTRODUCTION&PURPOSE
At Children’s Health, the security, management, and tracking of data across our institution is a high priority. In order to be good fiduciaries of the clinical data of research participants, Children’s Health has recently developed a database for research data requests. For researchers seeking assistance from Children’s AdvancedAnalytics(AA)team forclinicaldataextractionservicesforresearch purposes, the purpose of this Standard Operating Procedure (SOP) is to describe the process of reviewing and tracking data requests, and verifying that data request elements match the IRB-approved study documents.
2. SCOPE
This SOP applies to all study projects submitted to the IRB which list Children’s as a performance site and are requesting data collection. This SOP also applies to data requests for feasibility of a project and preparatory to research requests.
Data Request / Types:
• Feasibility Request – A data request for a non-IRB approved research project. For this request, the investigator is seeking aggregate numbers (no PHI or other identifiers will be provided) to determine the feasibility of a project at Children’s Health. No publication or presentation can be performed under a feasibility request, and the data cannot be removed from Children’s Health and needs to be stored securely.
• Preparatory to Research – A request for a non-IRB approved project. For this request, the researcher wants to access a select group of patients’
SOP#23: 04/14/2020; 06/10/2020; 11/08/2020; 08/25/2021