CDISC - SDTM
Course Length : Regular - 60 Days, Fastrack - 30 Days
Course Start : For Details Call +91 9247716307,
Limited seats per batch
Course Location : Hyderabad, India
Contact Us : Call +91 9247716307
 

Syllabus

 
  • A detailed review of SDTM concepts, SDTM domain models, and relationship tables
  • A discussion of common implementation issues
  • A workshop with CRF-annotation exercises that reinforce attendees' understanding of the SDTM and the SDTM implementation guide.
  • Understand the benefits of implementing them
  • Demonstrate how you can improve your data quality
  • Streamline workflow at investigative research sites and sponsoring organizations
  • Understand and communicate relevant business information that demonstrates the real world value of CDISC.
  • Standards in Clinical Research. 
  • Brief overview of the other CDISC concepts like CDASH, ODM.

SDTM
The SDTM (Study Data Tabulation Model) is a specification in the FDA eCTD Guidance as the model for submitting clinical and preclinical data to the FDA in support of marketing applications.

SDTM class consists of:

  •  CDISC mission
  • Background on CRT (Case Report Tabulation) and FDA guidance’s
  • SDTM history and maintenance process
  • FDA Critical Path Initiative
  • SDTM basic concepts
  • Introduction to SDTM general classes and special purpose models
  • Screen shots of SDTM reviewer tools
  • Model concepts and terminology
  • Detailed review of general observation classes
  • Core model assumptions
  • SDTM metadata model
  • SDTM standard domains
  • Creation SDTM custom domains

CDASH
The CDASH standard describes the basic data collection fields that are common to all therapeutic areas and all types of clinical research.

  • Purpose and basic concepts of the CDASH standard
  • Relationship between CDASH and the other CDISC standards
  • Conformance rules for CDASH implementations
  • Challenges of collecting data in de-normalized structures
  • CDASH Best Practice recommendations for data collection.
  • Principles of RELREC and SUPPQUAL for storing relationships between datasets, variables, and observations
  • Trial Design concepts
 

Overview

 
CDISC has collaborated with numerous other organizations on a global basis to analyze research regulations and processes. Through these collaborations and the work of thousands of volunteers worldwide over the past 14 years, a set of enablers that can recognizably accelerate the medical research process, from protocol through analysis and reporting has emerged.

From many years the different areas of clinical data flow ranging from collection to statistical analysis and submission.
 

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


Training in CDISC standards, coupled with a unique understanding of the everyday problems encountered when submitting data in SDTM, define.xml or ADaM to FDA.
 
CDISC
 Senior Statistical Programmer
 Senior Database Programmer
 Principal SDTM programmer
 Senior database programmer-SDTM
 Data Analyst programmer
 Clinical Programmer Analysts
 Senior Programmer
 Programmer-SDTM
 
 
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