About
The “Clinical Trial Document Management: A Program” 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 program combines theoretical lessons with practical exercises, including the use of document management systems and simulations of trial audits.
Aim
This program 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.
Program 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.
Program Structure
Module 1: Introduction to Clinical Trials
Session 1: Understanding the Drug Development Process
Session 2: Designing a Clinical Trial Protocol
Session 3: Essential Documents in Clinical Trials
Module 2: Investigator Site Files and Data Management
Session 4: Investigator Site Files (ISFs)
Session 5: Data Management and Quality Assurance
Session 6: Source Document Verification (SDV) and Source Data Validation (SDV)
Module 3: Pharmacovigilance and Compliance
Session 7: Pharmacovigilance and Safety Reporting in Clinical Trials
Session 8: Good Clinical Practice (GCP) in Action
Session 9: Compliance with ICH Guidelines in Clinical Trial Documentation
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.
Program 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.
Program Deliverables
- Access to e-LMS
- Real-Time Project for Dissertation
- Project Guidance
- Paper Publication Opportunity
- Self Assessment
- Final Examination
- e-Certification
- e-Marksheet