Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 112

 In the event of premature termination or suspension of a trial, promptly informs the investigator(s), the regulatory authority(ies), and IRB/IEC as applicable, of the termination or suspension and the reason(s) for termination or suspension (ICH E6(R2) 5.21 Premature Termination or Suspension of a Trial; Chapter 18 Clinical Trial Protocol and Amendments; Chapter 26 Investigator/Institution Close‐out; Chapter 8 IRB/IEC Roles and Responsibilities).

 Closes trial sites upon study completion (Chapter 26 Investigator/Institution Close‐out).

 Prepares and submits clinical trial/study reports of trial results to the regulatory authority(ies) whether the trial is completed or prematurely terminated as required by the regulatory requirements. The clinical trial reports in marketing applications will meet the standards of the ICH E3 Guideline for Structure and Content of Clinical Study Reports [3,4]. (ICH E6(R2) 5.22 Clinical Trial/Study Reports; Chapter 28).

 Permits audits/inspections by Regulatory Authority(ies) at ANY time! (ICH E6(R2) 5.1 Quality Assurance and Quality Control; Chapter 31 Quality Responsibilities).