ABSTRACT
Having thought through the scientific background to the proposed trial, having reviewed the protocol and had it approved by the ethics committee, having considered all the ethical implications of the trial, it is now necessary to face the cold day-to-day reality of conducting the study in your research unit, practice or hospital clinic. The scientific problem might be fascinating, but it is easy to lose sight of this in the mundane details of execution of the trial: scheduling patient visits, obtaining informed consent, checking entry criteria, collecting blood and urine samples, recording the data and filling in the forms correctly.
