Clinical Data Management

Program Overview

Clinovalife offers Clinical Data Management program focusing on the core modules required to understand the complete lifecycle of clinical trial data management. The program is designed to provide structured, module‑based learning covering clinical trial fundamentals, CRF design, database build, data validation, CDISC standards, and database lock processes used in global pharmaceutical and CRO environments.

Program Highlights

  • Structured Module-Based Learning
  • Industry-Oriented Curriculum
  • Understanding of End-to-End Clinical Data Lifecycle
  • Introduction to CDISC Standards
  • Real Clinical Trial Case Studies
  • Career-Oriented Training

Course Curriculum (Modules)

Module 1: Introduction to Clinical Research & Drug Development
Module 2: Overview of Clinical Data Management
Module 3: Clinical Trial Protocol Understanding
Module 4: Case Report Form (CRF) Design
Module 5: CRF Annotation & Metadata
Module 6: Database Design & Study Build
Module 7: Edit Checks and Validation Rules
Module 8: Data Collection & Electronic Data Capture (EDC)
Module 9: Data Entry and Data Review Process
Module 10: Query Management
Module 11: Data Cleaning and Data Validation
Module 12: Clinical Data Standards (CDISC Overview)
Module 13: Data Quality Control
Module 14: Medical Coding Basics (MedDRA / WHO Drug)
Module 15: Database Lock Process
Module 16: Study Close-Out and Data Archiving
Module 17: Regulatory Guidelines (ICH‑GCP, FDA, EMA)
Module 18: Career Opportunities in Clinical Data Management

Learning Outcomes

  • Understand the clinical trial lifecycle and role of data management
  • Design and review Case Report Forms
  • Understand database build and edit check concepts
  • Perform data validation and query management
  • Understand CDISC standards used in clinical trials

Target Audience

  • Life Science Graduates (B.Pharm, M.Pharm, BSc, MSc, Biotechnology)
  • Clinical Research Aspirants
  • Healthcare and Pharma Professionals
  • Students interested in Clinical Research Careers

Program Duration

Total Duration: 3 Months
Regular /Weekend / Online Batches Available

Tools Used

  • Electronic Data Capture (EDC) Systems
  • Medidata Rave and other EDC tool like Oracle clinical , 
  • Microsoft Excel
  • Clinical Trial Management Systems (Concept)
  • CDISC Standards Overview

Certification

Participants who complete the program and pass the final assessment will receive a Certificate in Clinical Data Management.

Contact / Admissions

Email: Info@clinovalife.com
Phone: +91 XXXXXXXX
Website: www clinovalife.com