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Monitoring
Monitoring activities cover application of a clinical trial to PMDA and contracts with investigational sites other than monitoring of progress in a clinical trial. Monitors at MIC check carefully about compliance with Good Clinical Practice (GCP), the Pharmaceutical Affairs Law, Protocol and Standard Operating Procedures (SOPs), as well as proper recording and reporting, and ensuring subjects' human rights and safety.
1. GCP compliance check on investigational sites and investigators assigned for the clinical trial
(1)Investigation of clinical sites those are candidates for a clinical trial
•Collection and/or review of SOPs regarding a clinical trial
•Investigation to determine capability of investigational sites through interview of personnel at clinical sites
(2)Investigation of capability of potential investigators
•Fact-finding for past history and achievements
•Collection of resumes
•Inquiry to find possibility of recruiting planned number of subjects
2.Requesting a clinical trial and contracting with investigational sites
(1)Preparation of required documents and material used for review at investigational sites when requesting a clinical trial to the sites
(2)Implementation of request application in predetermined period
(3)Responses to inquiries from Institutional Review Board
(4)Obtaining hospital director's permission of a clinical trial
(5)Contracting
3.Supply and withdrawal of investigational drug
(1)Supply of investigational drug to a hospital administrator of investigational drug, after making contract
(2)Explanation of storage method and instructions for handling the investigational drug to the administrator
(3)Withdrawal of unused investigational drug at the completion of the clinical trial
4.Monitoring
(1)Visits to a medical institution
(2)Preparation of a visit report (monitoring report)
(3)Progress control
(4)Review regarding compliance with GCP
(5)Providing information about a clinical trial
(6)Verification of Case Report Form with Source Data
(7)Items to check during a clinical trial and items to record in a monitoring report
•To check whether Informed Consent is obtained in written form from subjects prior to participation in a clinical trial
•To check whether only eligible subjects participate in a clinical trial
•To follow up subjects
•To check whether adverse events occurred
•To check whether investigators comply with protocol and GCP
•To check whether investigators fulfill their assigned duties
•To check control of investigational drug
•To provide relevant information such as safety information
5.Collection and review of Case Report Forms
(1)When a clinical trial is over on a subject, his/her case report form is collected.
(2)Verification of description in CRF
6.Source Data Verification
(1)To verify consistency of Case Report Form and Source Data such as medical records of patient kept at hospital
(2)To check proper storage of documents at hospital
7.Procedure for completion of a clinical trial
(1)At the end of a clinical trial, the required documents should be prepared and the proper procedures should be followed.
