This course is designed to provide students with an overview of the clinical data management process, including the elements involved in CRF designing, Programming, data collection and management, data quality assurance and assurance processes. Students will gain an appreciation for how clinical data are collected and managed throughout the healthcare system. They will learn about how to identify sources of error in clinical data records, perform analysis on their own health information, understand best practices for data analysis and interpretation
The field of clinical data management (CDM) has come about due to the requirement from both relating to medicinal drugs/device industry and the regulatory authorities for the development of medicinal products continues to accelerate, regulatory entities by requiring quality-assurance standards to be met in collecting the data used in the drug/device evaluation process.
The content and methodology of our courses are structured to complement self-directed learning. As such, participants will be able to review course material at their own pace, however, should complete the course within the allocated time provided for the course.
What will i learn?
- Introduction to Data management
- Clinical data management Lifecycle
- CRF Designing and Programming Edit checks
- Planning, implementation and data validation
- Data capture and presentation
- Query Management
- Clinical Data Extraction and review
- Clinical data quality assurance and quality control
- Introduction to documents involved in all phases of Data management (Start Up Phase, Conduct Phase and Closeout Phase)
- Career Opportunities
- This course is open to all individuals, especially the graduating individuals/Freshers in Pharmacy/Life science/Science domain, Engineering & Technology and Trainees seeking to obtain a general overview of the Clinical Data Management and to understand the scope & opportunities exist in the industry.
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General Module - Pharmaceutical Industry – Opportunities
Preview 00:36:53
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Module 1 - Data Management
Preview 00:18:27
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Module 2 - Clinical Data Management
00:15:49
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Module 3 - Start-up phase
00:25:54
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Module 4 - Conduct Phase
00:26:03
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Module 5 - E-CRF Designing and Edit Check Programming
00:38:08
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Module 6 - 21 CFR Part 11
00:16:38
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Module 7 - Data Management Plan
00:27:21
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Module 8 - Data Validation Guideline
00:24:00
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Module 9 - Quality Control Guideline
00:16:56
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Module 10 - Edit Checks
00:16:10
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Module 11 - Closeout Phase
00:10:50
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Live Interaction
Preview .
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Quiz - Multiple Choice Questions
0:15:00
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