Critical Documents. Before ImmunoGen initiates the study at a given site, it is the responsibility of the Investigator to ensure that the following documents are made available to ImmunoGen or their designee: • Curricula vitae of Investigator and sub-Investigator(s) (current, dated and signed or supported by an official regulatory document) • Signed and dated agreement of the final protocol • Signed and dated agreement of any amendment(s), if applicable • Approval/favorable opinion from the IRB/IEC clearly identifying the document and document revision reviewed, including but not limited to, the protocol, any protocol amendments, Investigator Brochure, Patient Information/ICF, and any other written information to be provided regarding patient recruitment procedures • Copy of IRB/IEC approved Patient Information/ICF/any other written information/advertisement • List of IRB/IEC Committee members/constitution or equivalent compliance statement • Study and Financial agreement(s) • Completed Form FDA 1572 or equivalent form • Completed Financial Disclosure Form Additional documents such as laboratory reference ranges and certifications will be collected during the study. Ongoing regulatory approvals and notifications, as required, must also be made available to ImmunoGen.
Critical Documents. Obtaining vital documents to complete the HCV eligibility application such as birth certificates, social security cards, etc.
