Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 107

 Is qualified and agrees to specific stipulations prior to trial conduct (ICH E6(R2) 4.1 Investigator's Qualifications and Agreements; Chapter 24 Investigator/Institution Initiation):Is qualified by education, training, and experience to assume responsibility for the proper conduct of the trial.Is thoroughly familiar with the appropriate use of the investigational product as described in the protocol and investigator's brochure.Is aware of and complies with GCP and applicable regulatory requirementsPermits monitoring, auditing, and inspectionsTrains site staff and maintains a list of appropriately qualified staff who are allowed to perform significant trial‐related duties (i.e., record or change trial data).

 Has, supervises, and maintains adequate resources for trial conduct; i.e., subject recruitment, qualified and trained personnel and third parties, certified and adequate facilities, and time. Additionally, the investigator will implement procedures to ensure the integrity of trial activities and data that are generated (ICH E6(R2) 4.2 Adequate Resources; Chapter 22 Monitoring Overview; Chapter 25 Investigator/Institution Interim Monitoring)

 Obtains approval of trial protocol and subject information from a qualified IRB/IEC. IRB/IEC approval must be obtained before implementing a new or amended or revised study protocol or subject information document. (ICH E6(R2) 4.4 Communication with IRB/IEC; Chapter 8 IRB/IEC Roles and Responsibilities).