Publisher's Synopsis
This classic SOP handbook provides twenty-one SOPs ready for immediate use or for adaptation to readers' requirements, allowing them to benchmark their existing SOPs against an internationally accepted set of SOPs. It contains SOPs applicable to the four major entities in the clinical development process: the sponsor, the clinical monitor, the investigator, and the Institutional Review board. The language ranges from the specific to the very general, depending on the activity described and the number and breadth of the existing regulations governing it. The handbook gives readers blueprints for setting up the procedural guidelines their companies need.
