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:
EU-PEARL Master Protocol Templates
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 dct@berryconsultants.com.
Download the maintained version of the DMC Charter Template here.
Currently this is unchanged from the final version released by EU-PEARL.