Investigational drug policy and procedure manual

11 rows ·  · CDER's Manual of Policies and Procedures Review of Investigational . of investigational drugs. Policy: A. The Pharmacy is responsible for the proper procurement storage, Pharmacy manual or other supportive materials that outline drug related preparation and procedures, as applicable. F. Authorization to Order Investigational Drugs. The Clinical Investigation Policy and Procedure Manual Document: CIPP written notification from the or documentation of contact, including who was contacted, the phone number, the time of the call, and a summary of the information provided. Expanded Access of Investigational Drugs.

investigational product control system, which includes the technical procedures for product ordering, control, dispensing, and accountability. In addition, the Pharmacist of Record is responsible for the establishment of internal policies and procedures for the safe and proper use of investigational products. The. • Investigational drug product handling manual (phar-macy manual), if available, which should include the following: • Interactive response technology (IRT) (e.g., in-teractive voice or Web response systems [IVRS/ IWRS]) instructions, if applicable • Description of investigational drug product (e.g., dosage forms, strength, packaging). Investigational drugs shall be administered in accordance with any applicable State or Federal Regulations and in accordance with any policies or procedures set forth by the Institutional Review Board. Responsibility for investigational drugs at clinical trial sites rests with the investigator and the institution. Responsibilities include maintaining records of an investigational drug.

An Investigational New Drug Application must be filed with FDA to test the is intended for use in a diagnostic procedure that confirms the diagnosis. and Drug Administration (FDA) to administer an investigational drug or biological product to humans. III. Procedure/Content/Scope. Back-Up Plan for Investigational Product Storage. Manual of Procedures clinical practices, and institutional policies and procedures.