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Advanced post graduate program in clinical research and management |
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post graduate program in clinical research and management |
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Course Details:
Covers all the following areas:
clinical research
clinical data management
pharmacovigilance
medical writing&
clinical trial management.
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PCCRCDM (Professional Certificate in Clinical Research and Clinical Data Management) |
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Course Content: |
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Clinical Trial Process
Clinical Trial Design
Ethics & Good Clinical Practice
Clinical Data Management
CRF Design
Data Entry
Data Collection
Data Load
Data Storage
Data Validation
Query Management
Data Archiving
Quality Systems, Sops & Audits
Regulatory Affairs & Compliance
Safety Management and Pharmacovigilance
Statistical Analysis & Reporting
Data Management Systems & Tools
CDMS
AERS
EDC
Analytical Tools
Documentation & Document Management System
Medical coding and medical dictionaries
Project Management
Security systems
Practical:
Clinical Data Management System
Study Set-Up
Database Creation
CRF Creation
Data Entry
Data Validations
Query Management
Database lock
Statistical Software
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post graduate Certificate in Clinical Research and Pharmacovigilance |
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Course Details:
Designing of Clinical Trials
Pharmacokinetics & Drug Interactions
Overview Definitions and Concepts
Managements of Clinical Trails
Audits and Inspection
Clinical Research Process Outsourcing
Basic in Pharmacology I Pharmacy
Drug Discovery & Development
Introduction to Pharmacovigilance:
Definition, relevance, application and scope.
Pharmacovigilance Planning
WHO, CIOMS, ICH
Safety Data Management
Safety information, Clinical trial information
Safety Data collection and Systems
Post- Marketing Surveillance
Clinical vs. post marketing drug safety
Post- Marketing safety in USA, Europe & Japan
Regulatory Submission
Safety reporting requirements
Individual case safety reports
Periodic safety update reports
Query management
Electronic safety reporting
Regulatory inspections
Signal Detection
Introduction to Signal
Signal detection process
Risk Management
Risk Maps
Safety assessment
QA in Pharmacovigilance
Types of SOPs
SOP maintenance & training
Admission Procedure
Eligibility
Minimum eligibility criteria for application to the course would be either of the following:
Applicants are recommended to have one of the following life Science degrees: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics)
Selection Procedure
To maintain high academic standard, the Institute gives due importance to the quality of students enrolled. To ensure this, the selection of individual student will undergo the following procedure:
·Personal interview
Screening and selection of students |
