Clinical Data Management (CDM) is an important stage in Clinical Research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management helps collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and analysis of studies across the spectrum of clinical research.
Course Objectives:
In this course, you will learn to:
- In-Depth Knowledge of Clinical Data Management: Starting with foundational principles, you’ll learn the lifecycle of clinical data, regulatory guidelines, privacy standards, data quality, and cleaning methods. You’ll gain a well-rounded understanding of CDM from start to finish.
- Advanced Data Management Techniques: As you progress, you’ll learn query management, data validation, coding systems, and data analysis—skills that are crucial in high-level CDM roles.
- Practical Expertise with EDC Systems: Hands-on sessions will walk you through essential EDC (Electronic Data Capture) systems, data security protocols, audit trails, and data cleaning practices.
- Familiarity with Industry Standards and Compliance: Through modules on regulatory compliance, CDISC, SDTM, and ADaM standards, you’ll understand the critical industry regulations that govern CDM, giving you the knowledge required for regulated environments.
- REDCap Project Experience: The REDCap project gives you hands-on experience in designing and developing electronic case report forms (eCRFs), annotating CRFs, and understanding the intricacies of data collection, annotation, and compliance.
Course content
Introduction to Clinical Research
- Introduction to Clinical Research
Terminologies in Clinical Research
Advantages of CR in India
Drug development process
- Overview of Drug Development
Clinical trial phases
BA/BE Studies
Good Clinical Practice (GCP)-ICH E6
- History Development of International Regulations in Clinical Research
- Good Clinical Practices
- Ethics committee
- Investigator Responsibilities
- Sponsor Responsibilities
- Protocol and Investigator Brochure
- Essential Documents
Clinical Data Management
- CFR Part 11
- CRF_Design_2
- Introduction to CDM
- Data Entry Methods
- Query Management
- Source data validation
- Future of Data management
Pharmacovigilance
- Adverse Event Reporting
- Recording of Event
- Medical Management of Adverse Events
- Handling Death
- Unbinding of Drug
- Clinical Safety and Pharmacovigilance
- E2A- Clinical Safety and Data Management
- Media 436
- Naranjo Assessment
- Order and Formulate to Determine the Quantum
Regulatory Affairs
- Application of Permission
- Approval of Clinical Trial
- CDSCO
- Code of Federal Regulation (CFR)
- CT_Rules_2019
- ICMR Guidelines
- Medical Devices
- ICMR Guidelines
- DoH Oct 2013
- Guidelines for Industry
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Course Prerequisites
- Graduation / B.Tech / B.Sc in Microbiology / Life Sciences / Botany / Zoology / Food Science / Food Technology / B.E / B.Pharma / M.Pharma / BDS / MBBS / BHS / BUMS / BAMS or any other discipline.
Who can attend
- Aspiring Clinical Data Managers seeking foundational to advanced knowledge in CDM
- Clinical Research Professionals looking to specialize in data management
- Students and professionals in Biotechnology, Life Sciences, and Health Informatics aiming to enter the clinical data field.
Number of Hours: 30hrs
Certification
Key features
- One to One Training
- Online Training
- Fastrack & Normal Track
- Resume Modification
- Mock Interviews
- Video Tutorials
- Materials
- Real Time Projects
- Virtual Live Experience
- Preparing for Certification
FAQs
DASVM Technologies offers 300+ IT training courses with 10+ years of Experienced Expert level Trainers.
- One to One Training
- Online Training
- Fastrack & Normal Track
- Resume Modification
- Mock Interviews
- Video Tutorials
- Materials
- Real Time Projects
- Materials
- Preparing for Certification
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