CDISC-SDTM Training

CDISC Training teaches programmers essential concepts about creating and validating SDTM (v 3.4 IG) and ADaM (v 1.2 IG) variables in key CDISC datasets (DM, AE, LB, ADSL, ADAE, and ADLB).

Clin Infotech Clinical Research Training Institute is one of the Best CDISC Training Institute in Hyderabad. It provides various industrial Training Courses in Hyderabad, like CDISC, Clinical Research, Clinical Data Management, SAS, etc. Pharmacovigilance with Database (EDC) Inform Architecture, Central Designer for pharmacy students and life science, health science graduates, and postgraduates. Trained students of CDISC through the CLIN INFOTECH Training Institute, Hyderabad gives full support to every medical research of any type from protocol by analyzing the progress and interpreting their results. Students trained from CLIN INFOTECH Training Institute Hyderabad have shown that they can reduce the resources by 70–90% in the start-up stages at the start of their research process.

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
• 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.

By the end of this course, you 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.

Course Features

• CDISC Training teaches programmers essential concepts about creating and validating SDTM (v 3.4 IG) and ADaM (v 1.2 IG) variables in key CDISC datasets (DM, AE, LB, ADSL, ADAE, and ADLB).
• Attendees learn how to create and process ISO8601 dates, hierarchy of adverse events variables and paired lab variables.
• Examples of both SDTM and ADaM dataset structures will be reviewed and compared. To help assure higher quality clinical data, a QC checklist will also be introduced.

Target Audience

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

Duration

• 60 Days (1 Hour/Day)
• 30 Days (2 Hours/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, Clin Infotech 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 student selection

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 Clin Infotech. A fast track weekend course will also be conducted for employees & aspirants of Clinical Research Industry.

For more information, contact:
📧 Email: careers@clininfotech.com