March 1, 2022

Validated REDCap is now available at Cumming School of Medicine!

We are excited to announce that the CRU has completed the validation of its REDCap 12.4.31 instance. This REDCap instance meets Health Canada/ICH GCP requirements to run phase 3 and regulatory clinical trials.

This marks the start of a largescale REDCap Revitalization initiative at the CRU. We have listened to your feedback and recommendations and will be evolving our REDCap services to better meet your needs. Examples include offering newer REDCap versions with additional features, enhanced support services to help study teams learn the REDCap tool, and a more transparent fee structure for easier budgeting. We will share additional information in the coming months, including a launch-date of our Revitalized REDCap services. For additional information, please see the attached frequently asked questions.

We are happy to assist you with your electronic data capture needs. Please feel free to initiate a project request at our service desk or by emailing us at cru@ucalgary.ca. We look forward to continuing our collaborations.

Frequently asked questions

What does "validated" mean?
  • Health Canada and ICH GCP outline requirements for electronic data capture for regulatory trials, such as clinical trials.
  • The CRU has thoroughly tested our REDCap platform and developed processes to ensure the instance sufficiently meets these requirements.
    • Our approach to validation was to use test scripts and draft supplementary standard operating procedures.
  • Note: Study teams are responsible for ensuring validation at the project level by testing and validating that the project setup functions as expected. The CRU has prepared guides to help study teams with project validation.
What are the benefits of a validated REDCap instance?
  • REDCap is an easy-to-use EDC platform. It is widely used and many researchers and study teams are already familiar with it. There is a significant international community of REDCap users, which creates a vast support network for continuous improvement of our REDCap service.
  • Other validated EDC tools (e.g., REDCap Cloud, DataFax) can be challenging to use and to set up databases. REDCap services are also offered at significantly lower cost than these other validated EDC tools.
What will this cost?
  • The CRU is developing a new pricing structure that will provide more support for all project types and greater flexibility based on project and researcher needs. Additional details to come as part of REDCap Revitalization.
    • Exact project development costs will continue to be estimated from intake meetings and consultations.
  • The CRU operates on a cost-recovery model. Annual maintenance fees help us recover overhead for maintaining the REDCap platform, such as system administration, backups, and supplementary license fees.
    • The fee for the validated instance will incorporate additional work required to achieve and maintain validation.
My project is currently on REDCap 7. Can I move it to REDCap 10?
  • The CRU is doing a phased rollout of REDCap 10. As part of REDCap Revitalization, we will be migrating all projects to REDCap 10.
  • Migration to REDCap 10 is mandatory. We will be decommissioning the REDCap 6 and 7 instances.
  • The phased approach enables us to migrate projects free of charge. Thank you in advance for your understanding.
  • Projects will be emailed with migration details and timelines. Migrations are estimated to start in March 2022.
  • Migration will not affect project data. Project data will remain secure and there is no data loss in the migration process.
  • If you no longer use your REDCap project and would like to close it, please contact us at cru@ucalgary.ca
Can I start a new project on REDCap 10?
  • If you are running a clinical trial, yes – you can start a new project on REDCap 10. Please contact us at cru@ucalgary.ca or via our service desk to initiate your project.
  • If you are starting a new CRU-supported project (i.e., the CRU is supporting project build and configuration), it will be built in REDCap 10.
  • Otherwise, new projects will start in REDCap 7 until the REDCap 10 instance is officially launched for all project types, at which point it will be migrated to REDCap 10.
    • If you believe you have unique needs that require REDCap 10 before the official launch, please contact us.
What will happen as part of REDCap Revitalization?
  • Some of the initiatives and new services included in REDCap Revitalization are:
    • Validated REDCap instance to support regulatory trials
    • A single unified instance requiring only one log-in
    • A new support structure, including training courses and drop-in hours for quick consultations
    • A new pricing model that’s more transparent and inclusive to help with budgeting and grant applications
Why is the CRU changing so much?
  • Research needs and technical solutions have evolved over time. Based on researcher feedback and input, we are changing to better meet those needs.
    • The focus of the CRU is to offer high quality data and research support services in a financially sustainable manner. Our website provides additional information on our renewed strategic vision.
  • As shared by many across the university, the CRU is facing increased financial pressure. We are taking this as an opportunity to find efficiencies and improve the services we offer.
  • Want to help us on our journey? We will be putting out a call for members to join an advisory board. Stay tuned for more details!
It sounds like the CRU is doing lots! How can I stay up to date on what the CRU is doing?
  • We’ll be posting updates and announcements on our website
  • Want to help us on our journey? We will be putting out a call for members to join an advisory board. Stay tuned for more details!

REDCap validation was supported in part by the Alberta SPOR SUPPORT Unit, which is committed to building capacity in patient-oriented research by sharing expertise with students and new researchers.