We would like to kindly make you aware of the following paragraph from the GCP ICH E6(R3) Guideline 3.16.1:
"The sponsor should ensure that data acquisition tools are fit for purpose and designed to capture the information required by the protocol.
They should be validated and ready for use prior to their required use in the trial."
Thus, we highly recommend you to consider our Full service to ensure validation and compliance with HRA and GCP.
If you are interested in a REDCap Full or REDCap Light database to set up on your own (with DCR support), please complete our contact form.
To order a REDCap Light database to set up on your own (without DCR support), please complete our database order form.
Please note:
- In case of REDCap Light, implementation and management of the databases is the responsibility of the sponsor or PI respectively.
Additionally, this service is only provided to members of the University of Bern or its University Hospitals.
- Implementation and management of the database is in this case responsibility of the sponsor or PI respectively.
This service is only provided for members of University of Bern or its University Hospitals.