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.
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.
- Standards Managers,
- Data Managers,
- 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.
60 Days (1 Hr/Day)
30 Days (2 Hr/Day)
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.
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
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 firstname.lastname@example.org.