Certification in Clinical Operations and Trial Management
Duration: 2 months theory + 2 months onsite training
Key Learning Outcomes:
- Master clinical trial planning and execution
- Learn site management and monitoring
- Understand regulatory compliance
- Develop project management skills
Course highlights
2 months classroom training
2 month industry training
Award of Completion
Course outline
| S. No | Topic | Duration (Hours) |
|---|---|---|
| 1 | History of Clinical Research and Drug Development Process | 2 |
| 2 | Introduction to the Ethical and Regulatory Frameworks of Clinical Research | 2 |
| 3 | Fundamentals of Health Research and Evaluation Methods | 6 |
| 4 | Overview of ICH E6-ICH GCP | 10 |
| 5 | Overview of Drugs and Cosmetic Act, NDCT Rules 2019 | 4 |
| 6 | Clinical Research Site Level Activities | 4 |
| 7 | Essential Documents in Clinical Research | 4 |
| 8 | Planning and Management of Clinical Trials | 2 |
| 9 | Study Start up Process | 2 |
| 10 | Essentials of Clinical Monitoring and Auditing | 2 |
| 11 | Basics of Clinical Data Management, Biostat and Pharmacovigilance | 2 |
| 12 | Bioavailability and Bioequivalence studies | 2 |
| 13 | Bio Ethics | 2 |
| 14 | Public Health Studies | 2 |
| 15 | Publication | 2 |
| 16 | Case Studies | 2 |
Career Paths
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