Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 122

While there are no formal regulatory or GCP obligations prescribed to a trial subject, as there are for the sponsor, investigator, IRB/IEC, the subject will be asked to comply with requirements of the protocol and other operational procedures. A subject who has a thorough understanding of what to expect from their trial participation, who provides complete and truthful health and other information to trial staff, who follows study procedures as instructed, and who knows of their rights for trial participation will help to assure protection of their of rights, safety, and well‐being, integrity of trial data, and general trial compliance with SOPs, GCP, and applicable regulatory requirements.

NOTE: If the trial subject is a minor or has a legally authorized representative (LAR), then the parent/guardian/LAR will assume the voluntary responsibilities on behalf of the research subject.

We will describe examples of what subjects may do to facilitate their own protection and foster trial quality.