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.

Aim

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.

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Workshop Objectives

Understand the regulatory environment and requirements for clinical trial documents.
Learn the use and management of eTMF and other document management systems.
Develop skills in maintaining document accuracy and integrity under audit conditions.
Enhance ability to manage document workflows in multi-site trials.
Prepare for leadership roles in clinical trial operations and management.

Workshop Structure

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

Participant’s Eligibility

Undergraduate degree in Life Sciences, Pharmacy, Medicine, or related fields.
Professionals in clinical research, regulatory affairs, or healthcare industries.
Individuals with a background in data management or an interest in clinical trials.

Workshop Outcomes

Mastery of clinical document management systems
Understanding of global regulatory requirements
Skills in maintaining and auditing trial documentation
Capability to lead document control teams
Preparedness for compliance and quality assurance roles

Fee Structure

Standard Fee: INR ~~3,998~~ USD ~~100~~

Discounted Fee: INR 1999 USD 50

We are excited to announce that we now accept payments in over 20 global currencies, in addition to USD. Check out our list to see if your preferred currency is supported. Enjoy the convenience and flexibility of paying in your local currency!
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