Duke Standard Operating Procedure Template



PURPOSE: To define the procedures for management of Investigational Product(s) [IP] according to the contractual requirements of the clinical trial.SCOPE: Applies to all site personnel involved in the implementation and coordination of clinical research. PERSONNEL RESPONSIBLE: Principal Investigator, Sub-Investigators, Study Coordinator and/or other pertinent staff who will conduct research. PROCEDURES: Please refer to the individual pharmacy’s and entity’s SOPs regarding IP managementPlease refer to OVCR website policies : ICH GCP 4.6- Investigational Product(s)TOOLS:Investigational Product accountability logs ................
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