Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 126

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.