Sponsor-based evaluation of the system for the execution of clinical trial at hospitals and related issues.
With the revision of the Good Clinical Practice (GCP) in 1997, the Clinical Trial Center was established at Saga University Hospital in 1999, where clinical research coordinators (CRC) of nurses and pharmacists have been carrying out support for clinical trials since June 2000. At present, two pharmacists, two nurses, and three clerical work assistants support the execution of clinical trials; however, in recent years the number of clinical trial commissions has been gradually decreasing. On this occasion, in order to carry out even higher quality and smoother clinical trials, we conducted a questionnaire targeting the sponsors of clinical trials (head monitors) to evaluate this hospital's system for the execution of clinical trials from the sponsor's standpoint. Moreover, for the purpose of comparison with the systems of other institutions, the same questionnaire was conducted on two other hospitals-the University of Occupational and Environmental Health, Japan and the Social Insurance Shimonoseki Kousei Hospital. The problems of the clinical trial execution in our team turned out lack of knowledge concerning GCP and our complex system from the result of the questionnaire.
Clinical Trial Center, Saga University Hospital, Saga, Japan.
Naoko
N
Hagimori
Masanobu
M
Tasaki
Kazuko
K
Kiyomatsu
Mayumi
M
Tomiyasu
Kohei
K
Nagasawa
Hiroshi
H
Fujito
Erika
E
Endo
Kojiro
K
Takahashi
Kazuya
K
Tamari
Yumiko
Y
Ushijima
Kazuyo
K
Shiraishi
Ayako
A
Takeuchi
Minako
M
Kitamura
Tsutomu
T
Suehiro
Toshihiko
T
Onishi
D002986:Clinical Trials as Topic; D006761:Hospitals; D006801:Humans; D007564:Japan; D009726:Nurses; D010595:Pharmacists; D011795:Surveys and Questionnaires