Selecting the trial team

This section contains the following:

Introduction

In every randomized controlled trial there are specific tasks and responsibilities that should be accomplished. The tasks and responsibilities must be clearly specified in the protocol and all participating staff must be aware of their responsibilities. Every member of staff should be a team player, enthusiastic and invested in the research. They should be convinced that the objective of the trial is to "investigate if ..." and not to "demonstrate that ..." . This statement facilitates the adherence to the protocol.

Staff should be aware of how time consuming the trial related functions will be and the salaries they will receive. It is necessary to remember that in developing countries usually the staff involved have little experience in research.

Things to consider when deciding on the number of people involved in the management of the trial.

the number of subjects involved in the trial
the follow-up period
the complexity of the intervention
the complexity of the measurement of the outcomes
the complexity of the data management systems
the type of trial (single center or multi center)
the funding.

Things to consider when recruiting staff

training issues - Good Clinical Practice training and training in ethical issues.
technical issues in the recruitment of the staff
how to deal with failures to recruit staff or a slow recruitment process.
how to deal with staff leaving and how to avoid problems when key staff leave.

Additional resources

Checklist of coordination team

Checklist of all those who should be involved in the management of a typical trial.

Checklist of team roles

The strengths and characteristics required are described. This has been contributed by Fernando Althabe and team, Buenos Aires, Argentina.