Validation

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.

Our Approach to Validation

ICH GCP states:

5.5.3 When using electronic trial data handling and/or remote electronic trial data systems, the sponsor should:

(a) Ensure and document that the electronic data processing system(s) conforms to the sponsor's established requirements for completeness, accuracy, reliability, and consistent intended performance (i.e., validation).

However it gives no guidance with regards to how that validation should be performed. Similarly, Health Canada issue no guidance, nor do they provide any form of certification. Health Canada may audit electronic systems during the course of a site audit in which case the system will be audited in the context of that clinical trial and the SOPs in use at the site.

WCHRI's approach to validation is to maintain a separate LTS (long term support) installation of REDCap, and to validate it using the testing scripts originally provided by the REDCap Consortium's Regulatory (21 CFR Part 11, HIPAA) and Software Validation Committee and which have subsequently been kept up to date by WCHRI's REDCap team. It is our intention that this is adequate documentation to satisfy the requirements of GCP however, the system has not been audited and we offer no guarantees. Investigators and institutional sponsors should take steps to ensure that the available documentation meets their requirements.

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.

Validation Documentation

The files listed below contain the validation output for the initial installation and each subsequent upgrade. Due to space limitations we are only including validation documents for versions 6.0 and beyond. Older versions are available on request.

Validation Documents