Читать книгу Randomised Clinical Trials - David Machin - Страница 108

At some place in the protocol, an overview of the critical stages in patient management and key points of assessment needs to be provided. At each of these assessments, whether at the first presentation of the consenting individual before randomisation, post‐randomisation at visits when active treatment will be given, or for visits merely for check‐up purposes, the precise details of what examinations should be made and the details to be recorded (on the trial data forms) must be indicated. In SQCP01 (2006) even those children with cleft palate randomised to delayed surgery will have the same assessment schedule as those randomised to immediate surgery as these time points represent important milestones in, for example, their speech development.