GOOD CLINICAL PRACTICE DATA BASE STORAGE MEDIUM AND GOOD CLINICAL PRACTICE SUPPORT DEVICE

摘要

PROBLEM TO BE SOLVED: To attain improvement in the efficiency and exactness of good clinical practice(GCP) concerning a GCP supporting device, with which the so-called GCP activity such as dosage or examination performed to the GCP object person (case) by a medical institute in the GCP to be clinically executed on the final stage of a medicine development process is supported in the aspect of information management, and a GCP data base storage medium storing a GCP data base for managing that information. SOLUTION: This device has a GCP database 331 for recording a GCP ID 3311 for specifying the GCP, GCP execution plan 3312, which is tied with that GCP 3311, describing the execution plan of GCP, patient ID 3313 specifying the object person of GCP, patient information 3315, which is tied with that patient ID 3313, expressing the profile of the GCP object person, dosage information 3316 specifying the dosage to the GCP object person, and examination information 3317 specifying the examined result of the GCP object person.