Page 179 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE
1. ACRONYMS
CHRA – Children’s Health Research Administration DUA – Data Use Agreement
ePSA – electronic Performance Site Approval
FUA – Facility Use Agreement
Research Administration SOP No: Q009
SOP Title: Integrify® Data Management System
HRPP Office – Human Research Protection Program IDS – Investigational Drug Service
IRB – Institutional Review Board
PI – Principal Investigator
PRC – Primary Research Coordinator PSA – Performance Site Approval QS – Quality Specialist
QRG – Quick Reference Guide
RA – Research Administration
SOA – Service Order Agreement SOW – Statement of Work
SOP - Standard Operation Procedure
2. SUMMARY / PURPOSE
The purpose of this Standard Operating Procedure (SOP) is to ensure consistency, manage compliance obligations, create operational efficiency, ensure business continuity, reduce the learning curve for staff, apply quality control, and to develop documentation standards for utilizing Integrify® Data Management System, a workflow automation platform for clinical research projects being performed at Children’s Health.
3. INTRODUCTION
For clinical research projects where Children’s Health is listed as a performance site for recruitment, procedures and/or resources, Children’s Health Research Administration (CHRA) receives notifications from the reviewing Institutional Review Board (IRB) or an institution’s Human Research Protection Program (HRPP) Of fice, and / or the study team that a study has been submitted to a reviewing IRB for review and approval. A database system was required to house and manage projects in a transparent and accountable manner which reflects not only the status of review in real time, sends automated notifications as needed to the research service partners, but also identifies rate limiting steps during the review process. Integrify® Data Management System, a work-flow automation platform, will be utilized to document and track performance via reports/dashboards, and review activity audit trails.
SOP No. 26, 07-14-2021; Update 07-28-21; Update 08-03-21; Final 08-11-21