Clinical Trial Document Management: A Hands-on workshop
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Course Overview
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Program Syllabus
Module 1
About
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.
Module 2
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.
Lead Instructor
Dr. Sarah Chen
PhD in Computational Mechanics from MIT with 15+ years of experience in Industrial AI. Former Lead Data Scientist at Tesla and current advisor to Fortune 500 manufacturing firms.
Limited SeatsClosing Soon
Clinical Trial Document Management: A Hands-on workshop
Professional Certification Program
🎥
FormatLive + Recorded
📅
Duration8 Weeks
📜
CertificationVerified
Module 3
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.
Module 4
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
Module 5
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.
Module 6
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
Module 7
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!
List of Currencies
Fee Structure
Standard Fee: INR 3,998 USD 100
Discounted Fee: INR 1999 USD 50
List of Currencies
Module 8
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Key Takeaways
- Access to Live Lectures
- Access to Recorded Sessions
- e-Certificate
- Query Solving Post Workshop
Module 9
Future Career Prospects
- Clinical Trial Manager
- Regulatory Affairs Specialist
- Document Control Specialist
- Quality Assurance Manager
- Clinical Data Manager
- Compliance Officer
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Module 10
Enter the Hall of Fame!
Take your research to the next level!
Publication Opportunity
Potentially earn a place in our coveted Hall of Fame.
Centre of Excellence
Join the esteemed Centre of Excellence.
Networking and Learning
Network with industry leaders, access ongoing learning opportunities.
Hall of Fame
Get your groundbreaking work considered for publication in a prestigious Open Access Journal (worth ₹20,000/USD 1,000).
Achieve excellence and solidify your reputation among the elite!
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Module 11
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