Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 110

 Oversees and reviews the progress of the investigation to ensure protection of subject rights and safety, data integrity, and compliance with the protocol, SOPs, GCP, and regulatory requirements.

 Selects qualified monitors and implements procedures for on‐ and off‐site and centralized monitoring of the progress of the investigation using a risk‐based approach and methods as outlined in a Monitoring Plan for the trial (ICH E6(R2) 5.18 Monitoring; Chapter 22 Monitoring Overview)

 Collects, reviews, and assesses adverse events for ongoing risk‐benefit evaluation of the investigational product and to notify all concerned investigator(s) and the regulatory authority(ies) of findings that could adversely affect the safety of subjects, impact the conduct of the trial, or alter the IRB/IEC's approval/favorable opinion to continue the trial (ICH E6(R2) 5.16 Safety Information). These notifications may be as single reports, protocol amendments, and/or updates to the investigator's brochure (Chapter 21 Safety Monitoring and Reporting; Chapter 25 Investigator/Institution Interim Monitoring; Chapter 16 The Investigator's Brochure; Chapter 18 The Clinical Trial Protocol and Amendments)

 Reports adverse drug reactions that are both serious and unexpected as per ICH E2A Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting and applicable regulatory requirements [2] (ICH E6(R2) 5.17 Adverse Drug Reaction Reporting; Chapter 21 Safety Monitoring and Reporting)

 Assesses and manages risk for quality management (ICH E6(R2) 5.0; Chapter 13 Risk Assessment and Quality Management).

 Selects qualified independent auditors to conduct audits per the Audit Plan and/or for an unplanned cause (ICH E6(R2) 5.19 Audit, Chapter 33 Quality Assurance Components; Chapter 34 Regulatory Authority Inspections) and promptly secures compliance and implements corrective and preventive actions for deviations from the protocol, SOPs, GCP, and regulatory requirements that significantly impact or have the potential to significantly impact subject safety and data integrity. If monitoring or audit observations reflect serious or persistent noncompliance on the part of an investigator/institution then the sponsor should terminate the investigator's/institution's participation in the investigation and promptly notify the regulatory authority(ies). (ICH E6(R2) 5.20 Noncompliance, Chapter 25 Investigator/Institution Interim Monitoring, Chapter 33 Quality Assurance Components, Chapter 34 Regulatory Authority Inspections, Chapter 31 Quality Responsibilities).