Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 111

 Submits reports of final trial status and outcome to IRB/IEC and regulatory authority(ies) as required (ICH E6(R2) 4.13 Final Report(s) by Investigator; Chapter 29 Essential Documents; Chapter 26 Investigator/Institution Close‐out; Chapter 8 IRB/IEC Roles and Responsibilities).

 In the event of premature termination or suspension of a trial, promptly informs the trial subject, arranges for appropriate medical care follow‐up for the subject, and informs the sponsor, IRB/IEC, and/or regulatory authority(ies) as applicable, (ICH E6(R2) 4.12 Premature Termination or Suspension of a Trial; Chapter 29 Essential Documents; Chapter 26 Investigator/Institution Close‐out; Chapter 8 IRB/IEC Roles and Responsibilities).

 Permits audits/inspections by Sponsor, IRB, and Regulatory Authority(ies) at ANY time! (ICH E6(R2) 4.1 Investigator's Qualifications and Agreements; Chapter 24 Investigator/Institution Initiation)