objectives of this chapter are:
1 Define and describe the role of trial subject
2 Describe the voluntary responsibilities of a trial subject regarding:Protection of rights, safety, and well‐beingIntegrity of trial dataTrial compliance
3 Describe Quality by Design Considerations to facilitate subject compliance with the trial requirements
10.2.1 The Definition and Role of Trial Subject
A trial subject is an individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control (ICH E6(R2) 1.57).
Trial subjects are needed for a clinical trial to receive the investigational product to obtain data to evaluate the safety and efficacy of the investigational product for eventual approval of the product to diagnose, treat, cure, prevent diseases. The trial subject will be administered the investigational product at the clinical research facility by the investigator or a qualified designee.
10.2.2 Voluntary Responsibilities of a Trial Subject
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.
10.2.2.1 Voluntary Responsibilities for Protection of Rights, Safety, and Well‐being
A subject may help to ensure the protection of their rights, safety, and well‐being by following the study and operational requirements.
10.2.2.1.1 Prior to Volunteering for a Clinical Trial
Prior to volunteering for a clinical trial:
A subject should understand what clinical research is and what to expect when they volunteer to take part in a clinical trial.
The potential volunteer should know of their rights for participating in a clinical trial. The general GCP rights are:Fully informed consent and voluntarily participate in a trial without coercionConfidentiality of their identity and health informationCompensation for trial‐related injury and for the time, effort, and expenses for their involvement in the studyMedical care for study‐related injury or intercurrent illness(es)The ability to withdraw from the study at any timeRights may be outlined in the consent form and/or in a separate document. In addition to GCP rights, sometimes rights are specifically stipulated by the institution or regional regulatory authority(ies).
The potential volunteer should ensure that they receive a copy of the consent form that has been approved by an IRB/IEC to take with them to review before they sign the consent form. The consent form and any other subject information documents will be in a language that the potential volunteer can understand. They may review the consent documents with their family and friends and ask as many questions as they need to from the research staff at the clinic site, the IRB/IEC, or other sources to help them understand the information contained in the consent form. The subject should thoroughly understand the following, among other required elements of consent (Chapter 19 Informed Consent and Other Human Subject Protection):That the trial is investigational and no claims of safety or efficacy can be made about the investigational product unless already proven and/or approved by the appropriate regulatory authority(ies)Who is sponsoring the trial and who is the investigator and their contact informationThe procedures involved in participating in the trialWhat are the risks (side effects of all study procedures and study treatments, investigational or approved) and benefits for taking part in the trialWhat alternatives they have to participating in the trialWhom to contact in case of questions or concerns regarding study procedures, health, or rights issuesWhat happens if they experience adverse events or other harm from being in the trialIf, when, and how much they will be compensated for being in the trialThey cannot be coerced to volunteer for the trial and that their participation is completely VOLUNTARY and they may withdraw at any time
10.2.2.1.2 Volunteering to Participate in the Trial
The investigator or a qualified designee will administer consent to the subject in a language they can understand and, if necessary, with a witness (Chapter 19 Informed Consent and Other Human Subject Protection). The potential volunteer will have ample time for their questions to be answered before they sign consent for the trial.
10.2.2.1.3 Participating in the Trial
To ensure continued protection of their rights, safety, and well‐being, subjects will ensure:
They are not asked to sign any revised consent form that has not been approved by an IRB/IEC
They are not asked to undergo any procedure for which they have not consented
Their study records remain available only to those who are approved via the consent to see their records
Their biological samples and diagnostic tests (e.g., imaging scans) are used only for the purposes of the study as they consented
Their biological samples are properly labeled with their allowed identification information
They are respectfully treated by research staff and not any differently from if they were clinic patients and not in a research study
They truthfully provide medical and medication history as requested for the trial at screening
Qualified personnel perform trial procedures as described in the consent form and record the findings in study records
They are administered the investigational product by qualified personnel and as described in the consent form
They are fully trained on how to self‐administer study treatment(s) and the requirements for storage and handling of the study treatment(s)
For self‐administered study treatments, they use the study treatments only as directed and do not share or hoard study treatments
They store, destroy, and ensure security (safeguard from pets or children or others not authorized to receive or handle the study treatments) according to the trial instructions
They record (e.g., in a diary) and report adverse events as instructed, noting
