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 that for an event they will be asked for certain information about the event; 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)