Building and Testing your Database

Building your Database

If you are new to REDCap and Health Canada regulated clinical trials you may wish to seek help with database build and implementation. To arrange for an initial consultation please fill out a support request. 

If the study team has the skills and resources to build the study database then you may wish to consider some of the free support that is provided by WCHRI's REDCap support team. 

Testing your Database

It is a Health Canada (GCP) requirement that study databases are "validated". This need for validation covers both the application software (REDCap) and the database that is built within the application (your REDCap project). WCHRI validates our REDCap installation (more information here) but the Sponsor (Principal Investigator) must be able to demonstrate that the study database has been tested and approved. Testing and approval must be done before the database is moved to production and used to collect participant data. Our suggested approach is to:

A testing and approval form is available here. This form helps document the testing process and should be signed by the Principal Investigator before the project is moved to production.

REDCap Study Database Testing 2023-08-10.docx

Change Control

Once the study database is live and data entry has started it may be necessary to make changes, for a protocol amendment for example. Just as the initial study database had to be tested and approved, any subsequent modifications must be documented, tested, and approved. We suggest the following steps:

Project Change Request.docx