PG Diploma in Clinical Data Management(Part Time)

Institute of Clinical Research (India)
In Mumbai

Price on request
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Important information

  • Post Graduate Diploma
  • Mumbai
  • Duration:
    12 Months
Description

Important information
Venues

Where and when

Starts Location
On request
Mumbai
C-9, Central Road No. 22, MIDC Industrial Area , Maro, 400093, Maharashtra, India
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Frequent Asked Questions

· Requirements

# A postgraduate or graduate in Bioscience/Life Sciences (with any of the following subjects: Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotech) with at least 50% marks in aggregate # A postgraduate or graduate with Chemistry as a subject with at least 50% marks in aggregate # A postgraduate or graduate in Pharmacy or Pharmaceutical Sciences

Course programme

Course Curriculum

* Clinical Trial Process
* Good Clinical Practice & other regulatory guidelines
* Protocol & CRF designing
* Clinical Data Management
o Data capture methods
o Data Entry
o External Data Loading
o Data Validation
o Query Management
o Data Storage & archival
* Quality Systems, SOP'S & Audits
* 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
o Study Set-Up
o GLIBS
o Data Entry
o Data Validations
o Query Management
o Database lock
o Validation procedures

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