The Present Status and Problems of Clinical Trials at The Jikei University Hospital : A Report by Clinical Research Coordinators

In the 3 years since the new Good Clinical Practice (GCP) guidelines for clinical trials came into effect, steady efforts have been made to improve and introduce innovations to the system of clinical trial management at The Jikei University Hospital. The Clinical Research Office was established to provide secretarial services, including clerical services for the Institutional Review Board and drawing up contracts for clinical trials, and to provide a liaison service by clinical research coordinators (CRCs) at sites of clinical research. As the role of CRCS in the hospital came to be understood more widely, requests for introductions of CRCS have increased. A system must be established under which CRCS are more readily introduced to improve the efficiency and reliability of clinical trials and thereby earn the confidence of sponsors. For this reason, more members of the hospital staff should deepen their understanding of what clinical trials and CRC mean and to cooperate to ensure future development of support system for clinical trials.