Investigational product instruction manual

 · Ideally, the documents included in the TMF are: Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.) Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.). investigational products (s) according to the protocol and applicable CTP policies (PCY, PCY and PCY). In certain cases and where specific HREC and Office for Research approval has been granted, investigators may assign some or all of the. ICH GCP • Requirement ¾ICH GCP “The investigator should be thoroughly familiar with the appropriate usewith the appropriate use of the investigational product(s) asof the investigational product(s), as described in the protocol, in the current investigator’s brochure, in the.

in the development and management of investigational products at a program and protocol level specifically in the development of Investigational Product Handling documents and tools (i.e. investigational product handling manuals, administration instructions, and dispensing guidelines, patient dosing instructions for utilization by clinical sites). ABBREVIATIONS (MANUALS AND FORMS) the proper receipt, use, and disposition of investigational products (IPs) being evaluated in DAIT - funded/sponsored clinical trials. This responsibility includes assuring that all clinical site. Provide clinical pharmacy expertise in the development and management of investigational product handling manuals/pharmacy manuals for utilization by clinical sites.

Study Drug/Investigational Product Compliance Log (MS Word, 30K) - Used to track study drug/investigational product disposition and accountability for each individual participant. This form may be used to track protocol adherence via amount dispensed and returned and is designed to be used in conjunction with the Study Drug/Investigational. Non-Amgen Investigational Product Dosage and Administration: HC3 is the standard intensive consolidation chemotherapy course based on modifications to the ALL (Associazone Italiana Ematologica Oncologia Pediatrica-Berlin-Franklin-Munster) AIEOP-BFM HR2 course. HC3 will be considered non-Amgen investigational product. Investigational Product Inventory 91 Background and Purpose 91 Contacting Investigational Pharmacy Services 92 Dispensing 93 Documentation 94 Adverse Event Management 95 Definitions 95 Documentation 96 Reporting Serious Adverse Events 96 Data Safety Monitoring 97 Data Safety Monitoring.