Certificate Course in Clinical Trials Data Management
Course
Online
Description
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Type
Course
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Level
Advanced
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Methodology
Online
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Duration
6 Months
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Start date
Different dates available
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Delivery of study materials
Yes
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Support service
Yes
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Personal tutor
Yes
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Virtual classes
Yes
The need for rigorous evaluation of components of health care is increasingly recognized worldwide as a global health issue. An important type of evaluation is the randomised controlled clinical trial. These courses are suitable for both those wishing to gain an overall understanding of trials before moving into the field, and those who have general or specialist experience in clinical trials and aim to broaden their role in the design, management, analysis and reporting of clinical trials.
Facilities
Location
Start date
Start date
About this course
Clinical Research Associate,Clinical Research Investigator,Study Coordinator,Data Manager / Biostatistician,Regulatory Affairs Manager, Clinical Trials Auditor,Clinical Project Manager,Clinical Research Manager ,Business Development Manager,Drug Safety Associate,Medical Writer
Reviews
Subjects
- Management
- Evaluation
- Data Management
- IT Management
- Analysis
- Reporting
- Biological database
- Pharmacovigilance
- Clinical Compliance
- Clinical Pharmacist
Teachers and trainers (2)
Dr. Kumud Sarin
Technical Head
Dr. Sachin Prajapati
Scientist-Clinical Research and Pharmacovigilance
Course programme
Course Content:
Module-I: Introduction to Clinical Trials
Module-II: ICH, GCP, IRB and Regulations for Clinical Trials
Module-III: Biostatistics
Module-IV: Bioavailability and Bioequivalence Studies
Module-V: Ethical and Legal Issues in Clinical Research
Module-VI:Design - randomization, trial size, data monitoring, and 'alternative' designs, Analysis and reporting
Module-VII: Case Study Report
Certificate Course in Clinical Trials Data Management