Planning & Funding: Consider feedback

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At this stage the necessary discussions with the sponsor(s), investigators, other members of the research team, organisations involved in the study, custodians of existing collections of data and/or tissues, and patient/participant groups, should have taken place, in order to work through arrangements for the following:

In light of these discussions, the protocol should be enhanced to include these arrangements. As more information comes to light, the protocol may need further revision.

The need for a study protocol and the information it should include is outlined in Develop protocol.