Berry Consultants were proud to be participants in the EU-PEARL project funded by the Innovative Medicines Initiative. The legacy website of the project can be found here: EU-PEARL.
36 leading organizations representing patients, clinicians, researchers, authorities and industry worked together to develop a generic framework and set of tools to facilitate the design, set-up and implementation of patient-centric collaborative platform trials.
One of the products of the project was a set of document templates to assist those wanting to develop their own platform trials.
These comprise templates for:
- The Master Protocol
- The Intervention Specific Appendix (ISA)
- The Statistical Analysis Plan
- The Data Monitoring Committee (DMC) Charter
- Guidance for the CTR cover letter for Master Protocol and ISA submission.
The versions of those documents at the close of EU-PEARL can be found here:
The DMC Charter Template is maintained by us, Berry Consultants. If you have any comments, suggestions or questions about the DMC Charter Template please email us at email@example.com.
Download the maintained version of the DMC Charter Template here.
Currently this is unchanged from the final version released by EU-PEARL.