Information to be Collected during a Trial

Abstract

Information must be recorded before a subject enters the trial, throughout the course of the trial, and at the end. Before the start of a clinical trial it must be documented that the patients have the condition under investigation, that there are no contraindications to their entering the trial, and that informed consent has been obtained. During the course of the trial both the benefits and adverse effects of treatment must be recorded to demonstrate that the patients may safely continue in the trial. At the end of the trial the final data must be recorded. These will include full details on defaulters and the attempts made to contact them. This chapter also considers the quantity of data to be collected, the design of documents, the questions to be asked, and the various stages of data preparation.