Clinical Data Management Webinar

Introduction

• Presenter: Chaitanya
  • Principal Data Manager with 8+ years of experience in Clinical Data Management (CDM)
  • Familiar with various CDM tools: Oracle Clinical, Rave, Inform, SQL, PL/SQL, and SAS
  • Knowledgeable in ICH-GCP and 21 CFR Part 11

Participants

• Nikhil, Amit, Nalini, Kabir, Natasha, Vinayak, Sarita, Rahul, Anisha

Agenda

1. Clinical Trials Overview
   • Definition and history
   • Guidelines (ICH-GCP)
   • Steps in clinical trials: Preclinical, Phase 1, Phase 2, Phase 3, Phase 4
2. Clinical Data Management
   • Stages and phases
   • Role of Data Manager in each phase
3. **Training Program
   • Enrollment process
   • Study materials and software
   • Support and query resolution
4. **Scope of CDM
   • Job opportunities
   • Companies involved in CDM
5. Activities of a Data Manager
   • Data setup, conduct, and closeout

Clinical Trials Overview

What is a Clinical Trial?

• Testing a new medication/formula/device on human subjects
• Goals: Determine efficacy and side effects

Key Historical Points

• 1946: Nuremberg Code established informed consent principles
• 1962: Thalidomide tragedy led to stricter regulations
• 1979: Belmont Report
• 1997: ICH-GCP introduced

Clinical Trial Phases

1. Preclinical Testing
   • Animal testing for dosage and safety
2. Phase 1: Healthy volunteers (20-80) for safety and dosage determination
3. Phase 2: Patients (100-300) for efficacy and side effects
4. Phase 3: Large-scale patient groups (1,000-3,000) to confirm effectiveness and monitor long-term effects
5. Phase 4: Post-marketing surveillance for long-term adverse effects

Regulatory Submission

• Data must be submitted to authorities (FDA, EMA) at each phase
• Approval from authorities is required for market release

Clinical Data Management (CDM)

What is CDM?

• Process of collecting, cleaning, and managing clinical trial data
• Ensures data accuracy and compliance with regulatory standards

Key Steps in CDM

1. Protocol Development
   • Defines trial structure and requirements
2. Investigator Selection
   • Based on qualifications and expertise
3. Patient Recruitment
   • Based on inclusion/exclusion criteria
4. Case Report Forms (CRFs)
   • Collects data from patients
5. Data Entry and Validation
   • Ensures data accuracy and completeness
6. Database Lock and Reporting
   • Data analysis and submission to regulatory authorities

Training Program

Course Structure

• Live webinars and interactive sessions
• Access to course materials, software, and support
• Assignments and quizzes for reinforcement
• One-on-one support for resolving doubts and issues

Modules

1. Study Startup: CRF design, checks, quality control
2. Cleaning Process: Data entry, discrepancy management, stakeholder interaction
3. Closeout: Pre-close activities, database lock/unlock

Certification

• Final project based on data management activities
• Evaluated by trainers
• Certificate awarded upon completion

Scope of CDM

Job Opportunities

• Numerous companies in India and globally involved in clinical research and data management
• Opportunities for both full-time and home-based roles

Activities of a Data Manager

Key Activities

1. Protocol Understanding
   • Identifying endpoints and designing CRFs
2. Checkpoint Development
   • Ensuring data accuracy with edit checks
3. Discrepancy Management
   • Resolving data discrepancies in CRFs
4. Medical Coding
   • Using dictionaries (MedDRA, WHO-DD) to standardize terminology
5. SAE Management
   • Handling Serious Adverse Events and reconciling data
6. Database Lock/Unlock
   • Finalizing data for analysis and reporting

Tools and Software

• Oracle Clinical, Inform, Rave for CRF design and data management
• SAS for data analysis and reporting

Conclusion

• Questions and answers
• Contact information: greatonlinetrainings.com, greatonline.in