Читать книгу The Fundamentals of Clinical Research - P. Michael Dubinsky - Страница 108

 Confirms qualification of investigator and site prior to initiation of the trial at the site (Chapter 24 Investigator/Institution Initiation).

 Confirms review and approval/favorable opinion of the trial by a qualified IRB/IEC. Obtains IRB/IEC name, address, composition, registration, copy of approval, and changes made to study documents by the IRB/IEC. (ICH E6(R2) 5.11 Confirmation of Review by IRB/IEC; Chapter 24 Investigator/Institution Initiation). Confirms approval/no objection from the regulatory authority(ies) to initiate the proposed investigational plan. (ICH E6(R2) 5.10 Notification/Submission to Regulatory Authority(Ies); Chapter 11 Regulatory Authority Roles and Responsibilities).

 Supplies investigational product and is responsible for the supply and handling of the product; i.e., the full chain of custody of the investigational product from shipment to the investigator to its return or destruction. (ICH E6(R2) 5.14 Supplying and Handling Investigational Product(S); Chapter 17 The Investigational Product (Clinical Supplies)).