Granular Level

Introduction

How to use this course

Before we begin...

1.1 Overview of the TMF and its importance in clinical research 1.2 Regulatory requirements and guidelines governing TMF management 1.3 Role of TMF indexing and document mapping in ensuring compliance

2.1 Understanding document indexing and mapping concepts 2.2 Importance of standardized naming conventions and metadata 2.3 Principles of organizing documents within the TMF structure

3.1 Strategies for identifying and classifying trial documents 3.2 Creating document types and categories for efficient indexing 3.3 Case studies illustrating document identification and classification processes

4.1 Techniques for mapping trial documents to the TMF structure 4.2 Best practices for maintaining document mappings throughout the trial lifecycle

5.1 Strategies for monitoring document completeness and quality 5.2 Conducting TMF audits to assess compliance with regulatory requirements, 5.3 Addressing discrepancies and non-compliance issues in document indexing and mapping