UBC ARC REDCap – Good Clinical Practice Requirements

Purpose

This document provides a list of UBC ARC REDCap related documents and standards that can be referenced by researchers making use of the REDCap software for data collection and management associated with clinical trials.  It addresses the requirements referenced in section 5.5.3 of the INTEGRATED ADDENDUM TO ICH: GUIDELINE FOR GOOD CLINICAL PRACTICE

Background

The REDCap platform is a secure web application for building and managing research data collection instruments. The platform is specifically designed to support online or offline data capture for research studies. The REDCap platform runs on server infrastructure physically located in BC, Canada, at the UBC University Data Centre (UDC). Two instances of REDCap are available to the UBC research community.

UBC ARC REDCap Flex runs on the Standard release of REDCap. The instance is kept up-to-date with the current version of REDCap and its latest features. REDCap Flex is suitable for most research projects.

UBC ARC REDCap Solid runs on the Long Term Support release of REDCap. Updates are only implemented to address security and stability issues. REDCap Solid is more suitable for projects that require a non-changing environment, such as registered clinical trials, or where the sensitivity of the data being collected mandates additional security controls and governance.

By using the UBC ARC REDCap Platform, users are agreeing to the UBC ARC REDCap Terms of Service.

The UBC ARC approach to validating REDCap

To demonstrate the institution’s system validation, UBC ARC provides a comprehensive list of governance documents describing standards and terms for ARC services, including REDCap specific standards. These comply with UBC Policy SC14: Acceptable Use and Security of UBC Electronic Information and Systems, and where applicable align with the UBC Information Security Standards. UBC ARC REDCap Solid runs on the Long Term Support release of REDCap, for which the REDCap Regulatory & Software Validation Committee provides validation package, with list of scripts used for manual testing of the system and has signed off on.

Reference Documents and Questions for Researchers

Requirements  ARC Documents  Questions for Researchers
System Setup, Installation, and use
  • ARCS-11: REDCap Platform*
  • How is the REDCap project setup? E.g., Data Access group is used because it is a multi-site study
  • Why specific features are used?
  • Who is setting up the REDCap project(s)?
  • How are the forms/surveys developed?
System Validation and Functionality Testing
  • ARCS-21: System Maintenance (Appendix A; Section 1)*
  • Upgrade plans for specific upgrades can be provided upon request. Please email UBC ARC REDCap Support at redcap.support@ubc.ca
  • How are the REDCap features tested to ensure they are setup appropriately? (e.g., survey distribution)
  • Are the different access levels tested?
  • Are equations written correctly?
Data Collection and Handling
  • UBC ARC does not collect research data on behalf of the research team.
  • How data is collected?
  • Who is collecting the data?
  • How access is managed?
  • How data is shared? With whom?
System Security Measures
  • How are research teams’ access managed?
  • Who should have access to what? Why?
System Maintenance
  • If forms need to be changed, are the changes tested to ensure good data quality?
  • After a software upgrade, what tests are ran to ensure good data quality?
Change Control
  • ARCS-21: System Maintenance (Appendix A; Section 1)*
  • Upgrade plans for specific upgrades can be provided upon request. Please email UBC ARC REDCap Support at redcap.support@ubc.ca
  • If forms need to be changed, are the changes tested to ensure good data quality?
  • After a software upgrade, what tests are ran to ensure good data quality?
Data Backup, Recovery
  • Are data backed up on a regularly basis? How are they backed up? Where are they backed up?
Decommissioning, Contingency Planning
  • If UBC ARC terminates the operation of the REDCap Platform, what are the contingency plans? (e.g., export data, user another survey tool recommended by the university)
Access Control
  • How are teams’ access determined and managed?
  • How are user’s access removed?
  • Documentation of when users have access to the REDCap project?
Audit Log
  • How the research team reviews the audit log?
  • On what schedule are the reviews performed?
Data Retention (25 years)
  • Researchers can export data from REDCap and store it on a secure file server
Training
  • How is the research team trained to enter data in REDCap?

 

* Documents can be publicly found on the UBC Advanced Research Computing website