Comprehensive Course in Clinical Trials data management
Certificate
Distance
Description
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Type
Certificate
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Methodology
Distance learning
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Duration
1 Year
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Start date
Different dates available
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. Suitable for: Research Associate,Student and Professional
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
- Clinical Trial
- Pharmacovigilance
- Data Management
- Biological database
- Distance Learning
- Regular
- Providing Study Material
- Giving Assistance
- Phoning Assistance
- Mailings
Teachers and trainers (2)
Dr. Kumud Sarin
Technical Head
Dr. Sachin Prajapati
Scientist-Clinical Research and Pharmacovigilance
Course programme
Duration of course is 12 months
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
Comprehensive Course in Clinical Trials data management