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. 

• See our training page for information relating to training and "drop-in" support sessions (delivered via Zoom).

• Review the information available on this website for hints and tips regarding study build and other relevant information, including:

  • Project best practices

  • Electronic consent

  • Moving a project to production

  • Data Quality

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:

• Enter sufficient test data to be certain that all aspects of the study database function correctly and that the database collect the data required by the study protocol. 

• Download an export of the REDCap log for the project (from the logging module - accessed from REDCap's left-hand menu). This will demonstrate what testing has been performed and by who.

• Download a PDF of the data collection instruments, including the saved data. This can be accessed from the "Other Export Option" tab of the "Data Exports, Reports, and Stats" module - also accessible from REDCap's left-hand menu.

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.

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:

1. Decide on the changes that need to be made and make those changes in a copy of your REDCap project. If you don't already have a copy for training, development, and testing our helpdesk team can create one for you.

2. Document the proposed changes on a project change request form. Decide how you are going to test those changes and write up those steps in the testing section of the form.

3. Once the changes have been made in the test project, test them fully and document the testing process on the form. If any of your tests fail, make appropriate changes and make sure that the document properly reflects those changes.

4. Once you are confident that the changes work correctly, and meet the needs of the study, have the PI (or designee) approve the changes by signing the form.

5. Now the changes have been approved they can be applied to the live REDCap project. Usually this is done by downloading the data dictionary from the test project and uploading it to the live project. However, not all changes necessarily involve the data dictionary and care must be taken when applying the changes.

6. Finally, complete the change control form by filling out the final section with the revision number from REDCap's project revision history page. You should also keep evidence of testing as, in the event of an inspection, Health Canada may wish to see it. We usually keep PDFs of test data. these can be downloaded from REDCap.