Validated REDCap

The Women & Children's Health Research Institute maintains a special installation of REDCap in order to support investigators who are performing clinical trials under a Health Canada clinical trials agreement (CTA). This system is not intended for commercial use (commercial sponsors should be using their own systems) but is intended to help academic researchers comply with the GCP requirement to use validated systems.

If you need to know if your study may require a CTA take a look at this page.

What are the implications of using the validated installation?

Users of our Validated Installation should note the following:

1. If you are running several projects in REDCap and they do not all require a validated installation, then you may find that your projects are not all in the same installation of REDCap. As a result your study staff may have different REDCap logins for different projects.

2. Our validated REDCap installation is based on the Long Term Support version of the REDCap software and it can take us a significant amount of time to validate each new release. As a result users may find that there is functionality in our "standard" install of REDCap that is not yet available in our validated install.

Project Validation

In addition to validating the REDCap application at the system level, project teams must be able to demonstrate that project configurations meet study requirements. Teams must be able to demonstrate that they have tested the REDCap project and a senior member of the study team has approved the project build. For additional information see our "maintaining compliance" page.

System Security

Our privacy policy document contains information relating to application-level privacy and security features.

This document includes additional technical information regarding system security.

21CFR11 Compliance

We are occasionally asked if REDCap is 21CFR11 compliant.

21CFR11 is Title 21, Part 11, of the United States Code of Federal Regulations. It is the Food and Drug Administration (FDA) legislation that sets forth the criteria under which the Agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. There is no Canadian equivalent.

REDCap has the features necessary to serve as the database component of a 21 CFR Part 11 compliant study. However, the software must be placed in an environment with servers, security, personnel, policies, procedures, training, validation and documentation that meet the requirements of Part 11 and the predicate rules for the underlying legislation. At best, REDCap can offer an application containing the required technical requirements of a compliant system but compliance is assessed at the study level. The system cannot be compliant in isolation from the study policies and procedures.

The University of Alberta's validated REDCap installation can be used as a component of a 21CFR11 project, but if compliance is required, it is up to the project team to implement the necessary policy and procedure and to demonstrate compliance.

LTS Release History

The following is a list of REDCap LTS versions that have been installed. Each upgrade was performed in order to bring our installation up to the most recently validated LTS version. In each case this included new functionality, bug fixes and security patches. Installation. upgrades and validation were performed by staff at the Women & Children's Health Research Institute, University of Alberta.

• 14.5.41 Emergency Upgrade 2025-01-31

  • All documents

• 14.0.44 Emergency Upgrade 2024-10-27

  • Community Validation

• 13.1.26 Emergency Upgrade 2023-04-21

  • 13.1.nn Minor Upgrades

  • 13.1 Core Validation

• 11.1 2022-11-25

• 9.5 2020-06-11

• 8.10 2019-11-29

• 8.5 2019-03-10

• 7.4 2018-07-04

• 6.1 2017-01-06

• 6.0 2015-12-04

• 5.9 2015-01-08

• 5.5 2013-09-05

• 4.13 2012-08-20

The Canadian REDCap Validation Group

The Canadian REDCap Validation Group is an informal committee of Canadian REDCap administrators that are collaborating to develop a standard approach to REDCap validation. Our approach to validation is outlined in this document.