The Clinical Research Coordinator Services Using “Personal Booklet” and “Subject Data Profile”

Abstract

Recently, pharmacists are playing actively roles in coordinating clinical trials under the protocol of each investigational new drug and also play an important role in the total management of clinical trials. Since April 1999, we initiated several new clinical research coordinator (CRC) services, such as, support for obtaining informed consent, the schedule setup of studies, followup of involved patients, monitoring and audit of studies and collaboration in writing case report forms.
As one of new trials we have developed in CRC services is a “Personal Booklet” of volunteers for clinical trials to inform the patients about the clinical trials and to also facilitate the communication between the patients and CRC. In addition, we made a “Subject Data Profile” to share all information concerning clinical studies among CRC's. We believe that such trials may help to greatly improve the quality of such CRC services.