e.g., medications or actions they took as a result of the event, when the event started and ended or the final outcome, and the severity of the event
They follow requirements for forbidden concomitant foods, drinks, medications, procedures
They receive a timely referral or timely and adequate medical care by a qualified healthcare professional for adverse events that occur as a result of their participation in the trial
They receive trial compensation as described in the consent form
Their questions are satisfactorily answered by qualified trial staff
They are provided any new information about the study or alternatives for participating in the study
Continue to undergo safety assessments as requested after discontinuation of study treatment(s)
Continue to submit trial information as requested after discontinuation from the study
They communicate as requested with trial staff and ask questions and express concerns about any trial issues as they arise
They have the freedom to withdraw from the study at any time. It is helpful if a trial subject communicates their intention to the investigator or other staff member to withdraw from the study (if they are relocating, for health reasons, other reasons) so that appropriate arrangements may be made to ensure continuity of their participation in the trial (e.g., relocate to another trial site) or continuation of safety follow‐up.
10.2.2.2 Voluntary Responsibilities for Data Integrity
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
10.2.2.3 Voluntary Responsibilities for Trial Compliance
A subject may help overall trial compliance by following the study and operational requirements as outlined above. Additionally, as they follow study protocol and operational procedures, they can cross‐check that the research staff is following study protocol and operational procedures as they interact with each other.
10.2.3 Quality by Design Considerations to Facilitate Subject Compliance with Trial Requirements
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)
10.3 Summary
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.
Knowledge Check Questions
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
