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Clinical Research & Pharmacovigilance

Clinical research is a branch of healthcare science that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.

# Course Content: (Course Code: GAC001)

Clinical Research

  • Pharmacokinetics and Pharmacodynamics
  • Drug discovery
  • Toxicology
  • Special toxicology
  • Predictions [beneficial & harmful]
  • Study design
  • Regulatory authorities (RA) & ethics committee (EC)
  • RA & EC submission
  • Essential Documents
  • Site selection
  • Site set up
  • CRC & CRA responsibilities
  • GCP
  • Schedule Y
  • Patient recruitment
  • Informed consent process
  • Monitoring visits
  • Documentation and study logs
  • Accountability, Interactive voice responsive systems, central lab
  • SAE reporting
  • Trial Master File
  • Data entry in the case report form(CRF)
  • ICF documentation
  • Source data verification
  • Consistency of the CRFs/eCRFs
  • IP storage
  • IP accountability
  • Patient recruitment and retention
  • Query management
  • Data alerts to CDM
  • All the visit reports
  • Audit ready stage
  • Completion of CRF’s/e-CRF
  • Archival of study documents
  • Resolution of query and database lock
  • Serious Adverse Event and DCFs within a specific timeline
  • Shipment or Destruction of IPs as per the sponsor requirements

PHARMACOVIGILANCE

  • Introduction to Pharmacovigilance
  • Role of WHO in Drug safety monitoring
  • EU perspective
  • US perspective
  • ICH Guidelines
  • Safety monitoring in pre-approval stages
  • Post-marketing surveillance methods
  • ICSR(Individual Case Safety Reports)
  • Aggregate reports
  • Coding Dictionaries
  • Case processing in-class assignments
  • Narrative writing
  • Real time project
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