Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 131

1 Who is a trial subject?

2 Why are the responsibilities of a trial subject voluntary?

3 What are some of the voluntary responsibilities for a subject to help facilitate the protection of their rights, safety, well‐being?

4 What are some of the voluntary responsibilities for a subject to help facilitate data integrity?

5 What are some of the voluntary responsibilities for a subject to help facilitate general trial compliance?

6 What are some quality‐by‐design principles that apply to protocol design that help to facilitate subject voluntary compliance?

7 What are some quality‐by‐design principles that apply to data collection methods that help facilitate subject voluntary compliance?

8 What are some quality‐by‐design principles that apply to study treatment(s) design that help to facilitate subject voluntary compliance?

9 Overheard:They ask a lot of questions just for curiosity and I don't know all that is in the consent form anyway.Investigator delegate who instructed a college student who volunteered as a healthy research subject to swallow the study medication (capsules) per the appointed clock time just as the subject was about to ask a question about the study. Beds for study subjects for the phase 1 first‐in human study were lined up side by side in the research facility. A clock above each bed was used to record the time of the study procedure. A nurse took the subject's vital signs, followed by another who drew blood, and the subinvestigator physician followed with the cup of water and study dose to research subject.Comment and discuss:Were any of the subject's rights violated in this scenario?Are there any issues with investigator delegation of responsibility at this site?