Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 130

A trial subject is volunteering to be administered an investigational product in a clinical trial. Those involved in the conduct of the trial must protect the rights, safety, well‐being, and confidentiality of the trial subject. Although there are no formal GCP or regulatory stipulations for research subjects to follow, the trial subject can also help to facilitate these protections, as well as the integrity of trial data and the overall compliance for the conduct of a clinical trial if the subject complies with study protocol and operational procedures. Trial subjects are therefore asked to comply with protocol and operational procedures but cannot be penalized for not following or coerced into following those procedures.

There a several voluntary responsibilities for a subject to help facilitate the protection of their rights, safety, well‐being, data integrity, and general trial compliance. Additionally the trial protocol, data collection methods, and study operations may be designed in a manner that also facilitates the protection of their rights, safety, well‐being, data integrity, and trial compliance.