Subject Withdrawal Criteria and Procedures Sample Clauses

Subject Withdrawal Criteria and Procedures. In accordance with the Declaration of Helsinki (in accordance with the applicable country’s acceptance), each subject is free to withdraw from the study at any time. The investigator also has the right to withdraw a subject from the study in the event of concurrent illness, AEs, pregnancy (see Section 8.1.5), or other reasons concerning the health or wellbeing of the subject, or in the case of lack of cooperation. In addition, a subject may be withdrawn from the study as described in Section 3.5 (stopping rules and discontinuation criteria), Section 6.4.2 (concomitant medications not permitted) and Section 8.1.7 (discontinuation due to AEs). Should a subject decide to withdraw from the study after administration of IMP, or should the investigator decide to withdraw the subject, all efforts will be made to complete and report the observations up to the time of withdrawal as thoroughly as possible. A complete final evaluation at the time of the subject’s withdrawal should be made (see Section 5.2.7) and an explanation given of why the subject is withdrawing or being withdrawn from the study. As far as possible, all efforts should be made to ensure the subject attends the Withdrawal (EOS) Visit, with at least 12 weeks follow-up after their most recent IMP administration. The reason for and date of withdrawal from the study must be recorded on the eCRF. If a subject withdraws consent, every attempt will be made to determine the reason. If the reason for withdrawal is an AE, or clinically significant laboratory test abnormality, monitoring will continue until the event has resolved or stabilised, until the subject is referred to the care of a local health care professional, or until a determination of a cause unrelated to the IMP or study procedure is made. The specific AE must be recorded on the eCRF.
Sample 1
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