- Selection of medical institutions and doctors to conduct clinical trials
Clinical trial request/contract. - Delivery and collection of investigational drugs Monitoring ・
- Confirm whether the clinical trial is progressing in accordance with GCP (Good Clinical Practice), clinical trial implementation protocol, and SOP (Standard Operating Procedure).
- Perform direct viewing (SDV: Source Data Verification) to check whether the case report form (CRF) matches the medical records, etc., and collect them.
- Document submission and procedures to IRB (Institutional Review Board)
Confirm whether documents required to be kept at medical institutions are properly stored Monitoring report creation Procedures for completing clinical trials, etc.
