CDISC SDTM

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 This email address is being protected from spambots. You need JavaScript enabled to view it. .

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Contact

GRATISOL LABS – HYDERABAD
KVR Enclave, 2nd Floor, 207, Gurudwara Lane,
Beside Satyam Theater, Above ICICI Bank,
Ameerpet, Hyderabad– 500016,
Cell: +91 9705790302 / +91 8885198390
E-mail: training@gratisol.com