CLINICAL DATA MANAGEMENT ( CDM )
Course Length : Regular - 90 Days, Fastrack - 60 Days
Course Start : For Details Call +91 9247716307,
Limited seats per batch
Course Location : Hyderabad, India
Contact Us : Call +91 9247716307
 

Syllabus

 
  •  Clinical Trial Process
  •  Good Clinical Practice & other regulatory guidelines
  •  Protocol & CRF designing
  •  Clinical Data Management
    • Data capture methods
    • Data Entry
    • External Data Loading
    • Data Validation
    • Query Management
    • Data Storage & archival
  •  Quality Systems, SOP’S
  •  Regulations & guidelines for CDM
  •  Safety Data Management
  •  Statistical Analysis & Reporting
  •  Data Management Systems & Tools
  •  Documentation & Document Management System
  •  Medical coding and medical dictionaries

Practical

  •  Clinical Data Management System
    • Study Set-Up
    • GLIBS
    • Data Entry
    • Data Validations
    • Query Management
    • Database lock
 

Overview

 
The clinical data management plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.
 

Eligibility

 
  • Ph.Ds in any science discipline
  • Postgraduates with specialization in any of the areas of molecular biology, genetics, microbiology, structural biology, genetics, chemistry, physics, statistics and biotechnology.
  • B. Pharm, M. Pharm, MBBS, MD, BE/B. Tech, ME/M.Tech etc.
  • Final year students of the above courses as a part of fulfilling their project work.
  • Students looking for Research opportunities abroad.
  • Research Scholars in any areas of life & chemical sciences.
  • Bachelors in Biotechnology, Microbiology, Bioinformatics, Life sciences, Biochemistry, Zoology, Botany and related discipline.
 

Course Goal


The main objective of this course is to develop experts/skilled professionals to perform clinical data management tasks by having a correct spatial orientation of clinical research data management

 Job opportunities:
The data management team creates an accurate electronic database that captures the clinical data in accordance with the study protocol. The data are cleaned according to the specifications contained in the data validation manual. The final deliverable is sending a final clean database to the client or biostatistics and programming group for statistical analysis and final study report.

Data manage team include
Clinical data associates
Clinical data manager
Principal clinical data manager
Manager, clinical data management
Group manager, clinical data management
Associate director, clinical data management
Managers, clinical data management
Group managers
Directors
 
 
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