P. Michael Dubinsky - The Fundamentals of Clinical Research

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 19Informed 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

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 19Informed 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.

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.

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

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.

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 20Data Collection and Data Management)

Considerations for forbidden concomitant foods, drinks, medications, and/or procedures that are practical and easy for subjects to comply