Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 129

A number of principles and operational considerations that promote GCP, quality, and compliance may facilitate subject compliance with the trial requirements. Study protocol design and trial operations considerations to foster subject compliance include:

 Considerations for formulating and packaging study treatments for the simplest and easiest self‐administration by the subject or care‐giver

 Considerations for required storage and handling conditions for subject self‐administered study treatment(s) and that the subject can comply

 Considerations for selecting and scheduling study procedures that are realistic for the research subjects to undergo

 Considerations for the design of informed consent forms and other subject information documents

 Considerations for the design and training of subjects on self‐administered questionnaires and diaries so that they are easy to understand and fill out based on the subject's cognitive abilities and dexterities (Chapter 20 Data Collection and Data Management)

 Considerations for forbidden concomitant foods, drinks, medications, and/or procedures that are practical and easy for subjects to comply

 Considerations for study blinding procedures that are easy for subjects and research staff to comply

See chapters on protocol and data collection design considerations and study operational considerations for more strategies and details (Chapter 18 The Clinical Trial Protocol and Amendments; Chapter 14 Trial Management; Start‐up, On‐Study, and Close‐Out)