抄録
Since the new Good Clinical Practice (GCP) was announced, clinical trials have been conducted based on a new system in our hospital. Six phase II clinical studies (involving 170 patients) were completed by December 1999. Service of a Clinical Research Coordinator (CRC) was approved by the Institutional Review Board (IRB), prior to a phase II clinical study on an antibiotic, and support service was started to obtain informed consent from 10 patients. The CRC serves to promote activities smoothly, from acceptance until the completion of clinical trials. CRC services are provided by two persons: a pharmacist and a nurse, in addition to their routine duties. Nurses care for patients and confirm the patient's consultation for the trial, while pharmacists are responsible for other work (participation in hearing sessions, support in obtaining informed consent) . Among the work conducted by pharmacists, the contents of assisted explanation for obtaining informed consent, description of medical records and case reports, and confirmation of required documents, are recorded in check sheets. We introduce our check sheets.
