📁 01.01 Trial Oversight

01.01.01 Trial Master File Plan

01.01.02 Trial Management Plan

01.01.03 Quality Plan

01.01.04 List of SOPs Current During Trial

01.01.05 Operational Procedure Manual

01.01.06 Recruitment Plan

01.01.07 Communication Plan

01.01.08 Monitoring Plan

01.01.09 Medical Monitoring Plan

01.01.10 Publication Policy

01.01.11 Debarment Statement

01.01.12 Trial Status Report

01.01.13 Investigator Newsletter

01.01.14 Audit Certificate

01.01.15 Filenote Master List

01.01.16 Risk Management Plan

01.01.17 Vendor Management Plan

01.01.19 Transfer of Regulatory Obligations 

01.01.20 Operational Oversight

📁 1.2 Trial Team

📁 1.3 Trial Committee

📁 1.4 Meetings

📁 1.5 General