Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 127

A subject may help to ensure integrity of trial data by following the study and operational requirements:

 They truthfully provide medical and medication history and information for adverse events as requested

 They complete study procedures per the protocol schedule

 They are fully trained on how to use and complete self‐administered questionnaires and study diaries

 They truthfully complete study questionnaires and diaries as directed

 They respect the “blind” for blinded treatment and do not attempt to decode their blinded treatment

 They respect their randomization assignment and do not switch or share study treatment(s) with other study participants

 It is helpful if a trial subject communicates their intention to the investigator or other staff member to withdraw from the study to ensure safety follow‐up and/or continued collection of other study data