During the initialisation of a project, a protocol is set up conform the ones used in real clinical trials. It states the hypotheses to investigate and the ways to test them. Common items in the protocol are:
- primary and secundary study endpoints
- sample size calculation
- project management: goals, milestones
An example of a protocol will be made available.
A Material Transfer Agreement (MTA) is used to formalise the participants' roles, rights and liabilities. After signing the MTA, the participant is granted access to the central database.
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