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Study Team

The specific structure of a 'study team' will depend on the design and complexity of the study.  For example, a simple questionnaire study could  be set-up and managed single-handedly (one individual) whereas other more complex clinical trials will likely involve many people, from different disciplines (and may include peer researchers1) and different organisations (employers).

Regardless of design and complexity, every study will have a designated Chief Investigator (CI); this is the person designated overall responsibility for the design, conduct and reporting of the study. The Chief Investigator is responsible for identifying collaborators, establishing a study management team where appropriate and delegating responsibilities to them according to their expertise and experience (including the appointment of a study manager/ study oversight groups where required); identifying recruitment sites / Principal Investigators (and assessing their viability) and other third parties

All organisations/individuals that make-up a study team should be able to demonstrate (evidence on file) that they have the appropriate expertise and/or training commensurate with the roles and responsibilities that they have been delegated by either the sponsor, Chief Investigator or Principal Investigator and that the appropriate contracts/agreements (including employment contracts) are in place prior to commencement of any work.

[1] A peer researcher is a person with lived experience of the issue being studied and is a member of the research team delegated responsibilities by the Principal Investigator (for example-delegated responsible for conducting specific interviews or assessments).