Advanced Diploma in Clinical Research – Clinical Data Management
About This Course
Specialized training in clinical data management, focusing on handling trial data, CRF design, database management, and ensuring data accuracy and compliance.COURSE HIGHLIGHTS 100% Placement Assurance.Outstanding Placement Track Record. Over 3000 students have been suc and pharma industries. Globally Validated Curriculum. Only Institute with In-house CRO facility.Classroom/ Practical training by...
Show moreWhat you'll learn
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Clinical trial & CDM fundamentals
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CRF design & data collection
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Data validation & discrepancy management
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Medical coding (MedDRA, WHO-Drug)
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Data quality checks & compliance
Course Curriculum
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Week 1 – Clinical Research Fundamentals
read- Phases of clinical trials & GCP overview
- Role of data management in research
Week 2 – Data Collection & CRF Design
read- Case Report Forms & electronic data capture
- Lab: Designing CRFs for a trial
Week 3 – Database Management
read- CDM systems (Oracle Clinical, Medidata)
- Data validation & discrepancy management
Week 4 – Data Cleaning & Coding
read- Medical coding standards (MedDRA, WHO-Drug)
- Data cleaning procedures & audit trails
Week 5 – Data Quality & Compliance
read- Data review, reconciliation, & compliance checks
- Role of QA in data management
Week 6 – Mini Project & Assessment
read- Hands-on project with mock trial dataset
- Review + placement preparation
Prerequisites
M.B.B.S / B.D.S / B.A.M.S / B.H.M.S.
B. Pharmacy / M.Pharmacy / B.M.L.T
BSc in M.L.T / B.P.T / BSc in Nursing.
BSc and MSc in Biotechnology, Microbiology, Genetics
B.E (Biotechnology) / B.tech (Biotechnology).
Biochemistry ,Botany , Zoology ,Statistics or life sciences.
Course Includes:
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1 Topic
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6 Lessons
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6 Articles
