Bhubaneswar | Cuttack

Training Services

Course Overview

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Objectives

Provide participants with a broad understanding of the basic principles employed in diploma clinical research both domestically and internationally.

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Duration

3 Months (Weekend Batch: Sat & Sun)

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Eligibility

MBBS / BDS / BAMS, BHMS / B.PHARM, M.PHARM / B.Sc, M.Sc (Life Sciences, Biotech, Nursing)

1

Clinical Research Operations

  • ICH-GCP Guidelines
  • New Drug & Clinical Trials Rules
  • TMF/eTMF
2

Regulatory Affairs:

  • Regulatory Agencies
  • Common Technical Documents – CTD
  • Introduction to eCTD
3

Pharmacovigilance (PV)

  • Introduction to Pharmacovigilance
  • Eudravigilance & Signal Detection
  • PSUR & CIOMS/MedWatch
4

Clinical Data Management (CDM):

  • Introduction to CDM & Process flow of CDM
  • Data entry & Database
  • Data review & Essential documents in CDM