Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 109

 Ensures informed consent of trial subjects prior to the subject undergoing any study procedure at the start of and during the trial (ICH E6(R2) 4.8 Informed Consent of Trial Subjects) and provides adequate medical care to the subject for trial‐related adverse events during and following a subject's participation in the trial, and ensures confidentiality of subject information (ICH E6(R2) 4.3 Medical Care of Trial Subjects; Chapter 19 Informed Consent and Other Human Subject Protection)

 Complies with protocol procedures and records, reports, and corrects any deviations (ICH E6(R2) 4.5 Compliance with Protocol; Chapter 25 Investigator/Institution Interim Monitoring).

 Follows randomization procedures and procedures for any unblinding (ICH E6(R2) 4.7 Randomization Procedures and Unblinding; Chapter 25 Investigator/Institution Interim Monitoring).

 Stores, handles, and administer the test article according to the protocol and IB, and accounts for receipt, use, return, and destruction of test article (ICH E6(R2) 4.6 Investigational Product(s); Chapter 25 Investigator/Institution Interim Monitoring).

 Reports adverse events to the sponsor (ICH E6(R2) 4.11 Safety Reporting, Chapter 21 Safety Monitoring and Reporting).

 Maintains source documentation and complete case histories for each subject in accordance with good documentation practices and the applicable regulatory requirements. Source documentation includes all activities from informed consenting to study completion. (ICH E6(R2) 4.9 Records and Reports, Chapter 25 Investigator/Institution Interim Monitoring; Chapter 29 Essential Documents).

 Permits monitoring and auditing by the sponsor (ICH E6(R2) 4.1 Investigator’s Qualifications and Agreements; Chapter 22 Monitoring Overview).

 Communicates the study status and information per the IRB/IEC requirements and sponsor and regulatory requirements (ICH E6(R2) 4.10 Progress Reports; Chapter 29 Essential Documents; Chapter 25 Investigator/Institution Interim Monitoring; Chapter 8 IRB/IEC Roles and Responsibilities).