Training Description:
The Study Data Tabulation Model (SDTM) is a specification for structuring pre-clinical and clinical data to support interoperable and reusable data sharing, including submissions to regulatory agencies.
The Ministry of Food and Drug Safety in Korea requires the use of Study Data Tabulation Model (SDTM) for submission of clinical trial data. This requirement is in line with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E3 guideline, which recommends the use of SDTM as a standard for organizing and presenting clinical trial data.
This training covers information in standards documentation SDTM v1.7 & SDTM Implementation Guide v3.3, including the following:
• A detailed review of SDTM concepts, SDTM-based domain models for human clinical data, relationship tables, and trial design
• A discussion of common implementation issues
• Exercises including the annotation of CRFs and the creation of datasets that reinforce attendees' understanding of the SDTM and the SDTMIG for clinical data
Register today for trainings at this discounted introductory price!
오늘 등록하고 할인된 입문 가격으로 훈련을 신청하세요.
Language: This training will be taught half in Korean and half in English (with Korean translation); training materials are in English.
Lead Instructor: Gary Walker (native English speaker)
Co-Instructor: Junseok Park (native Korean speaker)
