CLINICAL
RESEARCH [Link]
Bangalore Clinical
Research Institute
Clinical Data Management Syllabus
Industry Standard EDC Tools Practical Case Studies & Real-World Scenarios
Hands-on Training LMS Based Learning
Corporate Trainers & Industry Experts Placement Assistance & Career Support
CONTACT US:
FOR MORE INFORMATION +91 94038 90582
#19/19, 2nd Floor, 24th Main Rd, HSR Layout, Sector 1,
Bangalore - 560102. info@[Link]
Overview of Clinical Research
Overview of Clinical Research
Clinical Trial Phases
Phase 0 Study and Phase 5 Clinical Trials
1. Exploratory Studies
2. Safety Studies
3. Efficacy and Safety studies
4. Large Scale Trials
5. Post Marketing Studies
Clinical Study vs. Clinical Trials
Conduction of Clinical Studies and Observational Studies
Treatment Trials
Prevention Trials
Diagnostic Trials
Screening Trials
Quality of Life Trials
Fundamentals of Clinical Research & Drug Evaluation
Participants in Clinical Research
Protection and Ethical Considerations for Participation
Active Control Studies
Percentage of Drugs
Do Many Drugs Fail in Clinical Trials
Clinical Research vs. Usual Healthcare
Site and Duration for Clinical Studies
Clinical Research vs. Medical Care
Phases of FDA Approval
Reasons for Conducting Clinical Studies
Microdosing in Clinical Research
Dose Ranging Studies
Single Ascending Dose (SAD)
Multiple Ascending Dose (MAD)
Trial Design: Efficacy vs Effectiveness
Investigational New Drug (IND) & New Drug Application(NDA)
Clinical Data Management
Process flow Study Set-up
Data Management Plan Approved Study Protocol
Study Setup & Database Design Project Management Plan (PMP)
Tracking & Managing Clinical Trial Data Electronic Case Report Form (eCRF)
Data Collection & Management Specifications
Identifying and Managing Discrepancies Visit Form Matrix
Clinical Trial Systems & Technology Database (DB) Design & Development
Choosing Vendor Products Data Validation Specifications (DVS)
Implementing New Systems User Acceptance Testing (UAT)
System Validation & Quality Assurance IxRS (Interactive Response Technology)
Test Plans Integration
Data Migration & Legacy Systems Management Final Sign-Off & Go-Live
Data Management Plan (DMP)
Creating standards
Creating Hierarchies Data Entry in RDC and Discrepancy
SOPs and Guidelines Management in RDC
Working with CROS Auto Coder Algorithms
CRF Design Consideration
Remote Data Entry
Clinical Trial Management
Data monitoring and Interim analyses
Basic Statistics for Clinical Trials
Data Reconciliation
Clinical Trials in Practice
DCMs and DCIs
Reporting and Reviewing Clinical Trials
Protocol Development
Data Entry in RDC and Discrepancy
Management in RDC
Auto coder Algorithms
Trial Designs
Project Management
Regulatory Affairs, GCP and Ethical Guidelines
Data Management
Study Conduct
Data Creation & Collection Modules
CRF Tracking, Design & Data Entry
System Validation
Data Validation & Quality Checks
Testing & Data Base Readiness
User Acceptance Testing (UAT)
Managing Lab Data
Identifying and Managing Discrepancies
Collecting AE Data
SAE Reconciliation
Clinical Data: As per SOPs, Protocol, and
Study Specific Guidelines
Medical Coding
IxRS Reconciliation
Study Conduct Cont.
1. Data Review & Quality Control (QC)
Listing reviews & consistency checks
QC process & status reports
Final subject visit & follow-up completion
2. Medical Coding & Safety Review
3. Query Resolution & Database Review and Validation
4. Database Lock & Documentation (QC and QA)
5. Data Submission & Archival
Documentation finalized per DMP & SOP
Data archived/submitted for regulatory approval
Electronic Data Capture
Introduction to EDC Systems
EDC Work flow
Study Setup and Configuration
Data Entry and Validation
CONTACT US:
FOR MORE INFORMATION +91 94038 90582
#19/19, 2nd Floor, 24th Main Rd, HSR Layout, Sector 1,
Bangalore - 560102. info@[Link]
