Self Paced

Clinical Trial Document Management: A Hands-on Program

Streamline Success: Mastering Document Management in Clinical Trials

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Online/ e-LMS
Self Paced
1 Months


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.


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

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.

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

Fee Structure

Standard Fee:           INR 4,998           USD 110

Discounted Fee:       INR 2499             USD 55





Program Assessment

Certification to this program will be based on the evaluation of following assignment (s)/ examinations:

Exam Weightage
Mid Term Assignments 20 %
Final Online Exam 30 %
Project Report Submission (Includes Mandatory Paper Publication) 50 %

To study the printed/online course material, submit and clear, the mid term assignments, project work/research study (in completion of project work/research study, a final report must be submitted) and the online examination, you are allotted a 1-month period. You will be awarded a certificate, only after successful completion/ and clearance of all the aforesaid assignment(s) and examinations.

Program Deliverables

  • Access to e-LMS
  • Real Time Project for Dissertation
  • Project Guidance
  • Paper Publication Opportunity
  • Self Assessment
  • Final Examination
  • e-Certification
  • e-Marksheet

Future Career Prospects

  • Clinical Trial Manager
  • Regulatory Affairs Specialist
  • Document Control Specialist
  • Quality Assurance Manager
  • Clinical Data Manager
  • Compliance Officer

Enter the Hall of Fame!

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Publication Opportunity
Potentially earn a place in our coveted Hall of Fame.

Centre of Excellence
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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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