Introduction

The CRU’s REDCap instance is validated based on a review of ICH-GCP and Health Canada guidelines​. The CRU’s validated REDCap instance meets the guidelines required to host clinical trials.

‘Validation' refers to system or platform level validation in which the completeness, accuracy, reliability, and consistent performance of the electronic data capture system (EDC) is tested and confirmed.

The page below provides additional details about the validation process.

Validation Process & Components

Testing Scripts

The validation testing scripts used by the CRU were originally provided by the REDCap Consortium's Regulatory Body (21 CFR Part 11, HIPAA) and Software Validation Committee. These scripts have been subsequently updated by the CRU’s REDCap team, to account for new features included in higher REDCap versions.

With each update to the CRU’s REDCap platform, the validation process is carried out to ensure platform level validation is met.

The CRU’s validation of REDCap involves running 60+ test scripts, each script testing a single REDCap feature. Each test script document contains a series of step-by-step instructions, and each script was assigned to a CRU team member for testing. The tester systematically followed the instructions, marking each step as either PASS or FAIL. For a REDCap feature to be deemed validated, all steps in the test script had to be marked PASS. In the event of failed steps, the testing script was reviewed and investigated, before being assigned to a new tester for re-testing.

SOPs & Controlled Forms

Validation of REDCap also involves the creation and editing of 22 Standard Operation Procedures (SOPs) and a controlled form with a full list of SOPs related to platform validation. These SOPs were originally provided by the REDCap team at the U of A and were subsequently edited and adapted by the CRU team to reflect CRU procedure.

ICH GCP requires SOPs to be in place for system validation & functional testing, data collection & handling, system maintenance, system security, change control, and platform backups, recovery & decommissioning.

Project Level Validation

In addition to the platform level validation described above, the CRU has also developed processes and procedures for project level validation.

Every study team that engages the CRU in their REDCap project build, either in the form of a complete project build, custom work, or support for the implementation of individual features, will be required to fully test and validate their REDCap project. Project validation by the study team will include and ensure that all functional requirements have been tested, or deemed not applicable, and have been approved by the responsible parties before pushing the project to production.

Unsupported projects in which the study team is fully responsible for the project build and the CRU is not engaged, will have access to a modified version of this document to complete their own project level validation.

Clinical Trials on REDCap

Validated REDCap Platform Fee & Validation Documentation

Clinical trials can be hosted on our REDCap platform. Clinical trials will be subject to a Validated REDCap Platform Fee. Please see the CRU website for additional information about REDCap platform fees.

Clinical trials are subject to audit and review by Health Canada. In the event of such an audit, REDCap platform validation documentation may be required to be submitted by the study team. The Validated REDCap Platform Fee will provide study teams with access to this required platform validation documentation:

• Platform Validation Certificate - Study-specific document certifying that the clinical trial is hosted on the validated REDCap instance, hosted at the secure University of Calgary data centres.

• REDCap Data Management Plan - Study-specific document that details the plan for the collection, storage, analysis, and use of data both during and after a trial. This document covers what data is being collected, how data is collected, who will have access to the data, how the data is analyzed, the data quality and integrity measures in place, how long the data will be kept for, etc...