ABSTRACT
A collaborative approach between the management and research teams will help to promote strict adherence to the study protocol by staff at all levels of subject recruitment, data collection and data management. The purpose of the handbook is to maintain a document that itemises all of the methods being used in the study, and that catalogues all of the data collection forms. All research studies need a hierarchy of committees to oversee the conduct of the study, the handling of the data and the scientific reports from the study. Remember that regular meetings and regular interactions within the study team not only facilitate the decision-making process but also foster a sense of teamwork and belonging. The advantage of simple randomisation is that it balances prognostic factors perfectly between the study groups, provided that the sample size is large enough.
