Regulations for Good Clinical Practice Article 71

In the aspect of the handling of investigational product(s), the sponsor should:1.Ensure timely delivery of investigational product(s) to the investigator(s).2.Maintain records that document shipment, receipt, disposition, return, and destruction of the investigational product(s).3.Follow and maintain a system for retrieving investigational products and documenting this retrieval.4.Follow and maintain a system for the disposition of unused investigational product(s) and for the documentation of this disposition.5.Ensure that the investigational product(s) are stable over the period of use.6.Maintain sufficient quantities of the investigational product(s) used in the trials to reconfirm specifications if necessary.7.Maintain records of batch sample analyses and characteristics.For samples referred to in item 6 and item 7 for extending storage permits, samples should be retained either until the analyses of the trial data are complete or as required by the applicable regulatory requirement(s), whichever represents the longer retention period.