データマネジメントを中心とした市販後調査(PMS)コーディネートについて [in Japanese] The Coordinate Work on Post-Marketing Surveillance (PMS) by Data Management [in Japanese]
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GCP (Good Clinical Practice), a system to regulate clinical trial studies for investigating new drugs and postmarketing drugs, was revised and enforced in April 1997. Simultaneously, GPMSP (Good Post-Marketing Surveillance Practice) was enforced. We think that the regulatery authorities gave priority to GCP to improve the grade of postmarketing clinical trial studies to the rank of GCP in the first stage. However, PMS (Post-Marketing Surveillance) is expected to be strictly regulated in the near future. Recently, emphasis on the work of clinical trial study shifts for configuration and management of Clinical Research Coordinator (CRC). In August 1999, even at Kinki University Hospital, the work of CRC started by pharmacists and a nurse. As well as the work of CRC, the coordinating work of PMS was started by pharmacists at kinki University Hospital in October 1999. We herein describe this new work in order to allow it to become a part of EBM (Evidence Based Medicine). Concretely, we present the following five points regarding the coordinate work of PMS ; [◯!1] confirmation of the state of the prescription of the Investigational drug [◯!2] confirmation of the state of the prescription of the combination drugs [◯!3] confirmation of the state of any adverse events (include unusual change in the laboratory data) [◯!4] posting of objective data from source documents on the case report forms [◯!5] the administration of the daily program for investigational drugs, and so on. In addition, we also describe some pending subjects as well.