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Course Modules For Clinical Trials
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Modules |
| 1. |
Contract Research 1
- Introduction
- Contract Research Organizations
- Contract Research Areas
- Contract Research Delivery Models
- Contract Research Business Environment
- Contract Research Information Sources
- IT and Contract Research
- Regulatory Affairs and Contract Research
- Case- Studies
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| 2. |
Clinical Trials & Regulation
- Introduction
- Features of Clinical Trials
- Good Clinical Trials Practices
- Bio-availability Studies
- Designing of Clinical Trials Studies
- Clinical Trials Delivery Model
- Clinical Trial Informatics
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| 3. |
Contract Research and Clinical Trials Environment
- Introduction
- Contract Research and Clinical Trial Environment
- Non-Clinical Safety Studies
- Choice of Control Group
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| 4. |
Schedule - Y
- Application of Permission
- Approval of Clinical Trial
- Responsibilities of Sponsors
- Informed Consent
- Human Pharmacology
- Post-Marketing Surveillance
- Structure, Contents and Format for Clinical Trial Studies
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