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.