Advance Diploma in Clinical Research & Clinical Trials
Gain complete command over trial lifecycle management, ICH-GCP E6(R2), ethical approvals, trial protocols, source documentation, subject recruitment, and clinical trial monitoring.
- Introduction to Clinical Research & Drug Development
- Ethics in Clinical Research (ICMR & ICH-GCP)
- Institutional Ethics Committee (IEC) Filings
- Essential Documents & Trial Master File (TMF)
- Investigational Product (IP) Accountability
- Source Data Verification (SDV) & Monitoring Visits
- Hands-on rotation in 7 partner hospitals in Nagpur
- Shadowing senior Clinical Research Coordinators (CRCs)
- Patient screening & informed consent simulation
- Mock CDSCO regulatory inspection drills
Clinical Research Coordinator (CRC), Clinical Research Associate (CRA), Site Quality Specialist, Clinical Trial Assistant (CTA).