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CDISC SDTM - Gratisol Labs

Gratisol Labs with its vast expertise and familiarity with the CDISC standards is a pioneer in Asia Pacific market to impart the SDTM training pertaining to the standards in Clinical Trial Market.

COURSE DESCRIPTION:

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. We provide complete In-depth training on CDISC SDTM concepts with practical implementation exposure. Our Course curriculum includes:

  • Standards in Clinical Research.
  • SDTM Introduction & Standards.
  • Application of SDTM Standards.
  • Brief overview of the other CDISC concepts like CDASH, ODM.
  • Creation of SDTM annotated CRF
  • A detailed review of SDTM concepts,
  • SDTM domain models, and relationship tables,
  • A discussion of common implementation issues,
  • A demonstration with CRF-annotation exercises that reinforce attendees’ understanding of the SDTM and the SDTM Implementation Guide.

At the end of the course audience will learn

  • The theory behind SDTM and the format of data that will be required for submission to the FDA.
  • Key SDTM concepts.
  • How to represent various types of collected data in the SDTM format.

TARGET AUDIENCE:

  • Standards Managers,
  • Data Managers,
  • Statisticians,
  • Programmers, and others involved in the creation or submission of data.

This course is also intended for those within regulatory agencies who will use or process data in this format.

DURATION:

60 Days (1 Hr/Day)
30 Days (2 Hr/Day)

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) / M.Tech (Biotechnology), B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics)   and all professionals working with Pharmaceutical companies, CROs and Hospital.

SELECTION PROCEDURE:

To Maintain High Academic Standard, Gratisol Labs 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

CERTIFICATION:

Certificate will be provided for this Course on successful completion of Assignments & Projects. Certificate would be awarded at the end of the program by Gratisol Labs.
A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.  For more information, please contact Gratisol Labs at training@gratisol.com.

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