Clinical Trial Document Management: A Hands-on workshop

The "Clinical Trial Document Management: A Workshop" offers a deep dive into the critical role of document management in the success of clinical trials. Over the course of one month, participants will engage with the standards and practices that ensure compliance with international regulatory bodies, learning how to maintain, store, and handle clinical documentation effectively. The workshop combines theoretical lessons with practical exercises, including the use of document management systems and simulations of trial audits.

This workshop is designed to equip participants with the skills and knowledge to manage and oversee documents in clinical trials effectively. It aims to enhance understanding of regulatory requirements, document integrity, and compliance within clinical research, preparing participants for leadership roles in clinical operations.

Modules 1: Session 1: Introduction to Clinical Trials

• Understanding the Drug Development Process
• Overview of Clinical Trial Phases and Objectives
• Ethics and Regulatory Guidelines in Clinical Research

Session 2: Designing a Clinical Trial Protocol

• Step-by-Step Protocol Development
• Key Components of a Comprehensive Protocol
• Interactive Group Exercise: Drafting a Sample Protocol

Session 3: Essential Documents in Clinical Trials

• Importance and Purpose of Key Documents
• Hands-on Activity: Creating Informed Consent Forms (ICFs)
• Developing Case Report Forms (CRFs) for Data Collection

Module 2: Session 4: Investigator Site Files (ISFs)

• Role and Importance of Investigator Site Files
• Contents of ISFs and Maintenance Procedures
• Ensuring Compliance and Inspection Readiness

Session 5: Data Management and Quality Assurance

• Data Collection and Entry Techniques
• Practical Exercise: Using Electronic Data Capture (EDC) Systems
• Quality Control and Data Validation in Clinical Trials

Session 6: Source Document Verification (SDV) and Source Data Validation (SDV) in Clinical Trials

• Understanding SDV and Source Data Validation Processes
• Implementing SDV in Clinical Trial Monitoring
• Ensuring Data Integrity and Accuracy

Module 3: Session 7: Pharmacovigilance and Safety Reporting in Clinical Trials

• Requirements and Procedures for Pharmacovigilance
• Safety Reporting and Adverse Event Documentation
• Role Play: Managing Adverse Events and Reporting

Session 8: Good Clinical Practice (GCP) in Action

• Interactive GCP Guidelines Program
• Compliance and Auditing Simulation
• Addressing Real-world Challenges in Clinical Trials

Session 9: Compliance with ICH Guidelines in Clinical Trial Documentation

• Overview of ICH Guidelines for Clinical Trials
• Ensuring Compliance in Trial Documentation
• Good Documentation Practices (GDP) in Pharmaceutical Manufacturing