REDCap for Clinical Trials

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 application (CTA).

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

For additional information regarding system validation, visit our validation page.

Licensing

The University of Alberta licenses REDCap for "Non-Commercial Research Purposes". As a result, REDCap cannot be used for commercial projects funded by for-profit organizations. REDCap may be used for industry-funded investigator-initiated clinical trials, provided the study sponsor is the University of Alberta or a WCHRI / MICYRN affiliated research institute.

Maintaining Compliance

Compliance with clinical trials regulations is the responsibility of the study Sponsor, Principal Investigator and study sites. For most investigator-initiated clinical trial this means the Principal Investigator. Health Canada released a new 99 page guidance document in August 2019. A copy is available here:

• Guidance Document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human Subjects”

The following documents (below) are available to help study sites maintain and document compliance when using REDCap for a Health Canada regulated clinical trial.

In addition, the study team should have an appropriate internal agreement or legal contract that defines tasks, such as study hosting and data management, that are to be performed by groups that are not part of the study team. We can provide this documentation on request.

For information relating to project database build, testing, and PI approval please see this page.