Читать книгу Randomised Clinical Trials - David Machin - Страница 111

In contrast to the previous section, here the precise details of the items required at each assessment should be specified. The items might not be listed exhaustively but are often indicated by reference to the trial forms with a set of specimen forms bound into the protocol. In PRESSURE (2000), skilled personnel were trained about detailed aspects of the protocol, including the examination and documentation procedures. Whenever possible, it is important to complete the documentation as the examination proceeds. Investigators should not rely on making routine clinical notes and sometime later completing the trial‐specific forms, as the notes will not have been designed for trial‐specific purposes and important items may be omitted. The protocol should make clear which form or forms are applicable for each assessment – so numbering the different trial forms in a logical manner is important for this. We return to data collection forms in Section 3.14 below and give some examples in Chapter 4.