Programme Parameters
Graduate / Intermediate
12 Weeks (120 Hrs)
Online (e-LMS)
• A basic understanding of the subject area and fundamental programming or scientific concepts.
• A laptop or desktop with a stable internet connection.
• Willingness to complete assignments and the capstone project.
About This Course
Data Management in Clinical Research involves the systematic collection, processing, and analysis of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards. Every participant receives a verified e-Certificate and e-Marksheet from the Deep Science & Technology Consortium.
🎯 Program Aim
Data Management in Clinical Research involves the systematic collection, processing, and analysis of clinical trial data to ensure accuracy, integrity, and compliance with regulatory standards.
📋 Course Objectives
1. Translate biotechnology theory into practical, reproducible analysis.
2. Assemble a documented case study that evidences your applied capability.
👥 Who Should Enroll?
• Master's and senior undergraduate students specializing in biotechnology
• R&D engineers and working professionals applying biotechnology in industry
• Academics and educators building research or teaching capacity in biotechnology
🚀 Key Learning Outcomes
• Tangible, reproducible biotechnology work to show supervisors or employers.
• A verified e-Certificate of competency and e-Marksheet from the Deep Science & Technology Consortium.
💎 What You'll Gain
Live & Recorded Sessions
Lifetime access to class recordingse-Certificate on Completion
Cryptographically verified credentialPost-Programme Support
Direct access to mentors & councilHands-On Experience
Notebooks, real-world code & datasetsCurriculum Outline
Foundations of Clinical Data Management
Understand data management processes, roles, and regulatory frameworks in clinical research • Apply principles of data quality, integrity, and security to protect sensitive clinical information • Evaluate the importance of standardized data management practices for reliable research outcomes
Data Collection and CRF Design
Design effective data collection tools and Case Report Forms (CRFs) for clinical trials • Implement data validation protocols and quality control strategies to ensure accurate capture • Optimize CRF structures to minimize errors and streamline downstream data processing
Electronic Data Capture (EDC) Systems
Explore EDC system architecture and advantages over traditional paper-based data collection • Configure and deploy EDC platforms for efficient clinical trial data management • Integrate EDC workflows with existing clinical research infrastructure and processes
Data Entry, Cleaning, and Validation
Execute systematic data entry processes with rigorous quality control checkpoints • Apply data cleaning techniques to identify and resolve inconsistencies, duplicates, and outliers • Validate clinical research data against predefined rules to ensure regulatory compliance
Database Design and Query Management
Apply relational database design principles to organize complex clinical datasets efficiently • Generate, track, and resolve data queries to maintain database accuracy and completeness • Optimize database structures for rapid retrieval, reporting, and audit trail maintenance
Data Monitoring and Quality Assurance
Implement risk-based monitoring strategies to prioritize data quality oversight efforts • Conduct source data verification to confirm accuracy and traceability of clinical records • Establish quality assurance frameworks that align with ICH-GCP and regulatory guidelines
Statistical Analysis Planning and Methods
Develop comprehensive data analysis plans with appropriate statistical methodologies • Calculate sample sizes and perform power analyses to ensure study statistical rigor • Select and justify descriptive and inferential statistical techniques for diverse research questions
Technical Specifications
| Parameter | Requirement |
|---|---|
| Covered Tool / Platform | SAS |
| Covered Tool / Platform | SPSS |
| Covered Tool / Platform | Electronic Data Capture (EDC) Systems |
| Covered Tool / Platform | Database Management Tools |
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