Intermediate Fundamentals of Clinical Programming

Intermediate Fundamentals of Clinical Programming

Intermediate Fundamentals of Clinical Programming is a course designed to increase knowledge of CDISC programming through practical examples of standard implementation.

This is an 8-week course designed for the intermediate SAS programmer wanting to learn more about the CDISC SDTM model. This course offers an in-depth review of the SDTM General Observation Class (Interventions, Events, and Findings) as they relate to targeted domains. For each specific general observation class, complex modeling examples will be studied. This course provides a broad understanding of the challenges in modeling clinical trial data when implementing the SDTM standards. In addition, this course will provide an overview of the define.xml v2.0 component of SDTM, its supplements, the Reviewer’s Guide, and SDTM validation. Learning outcomes will be assessed upon completion of the course through homework and targeted testing. This will ensure understanding of the learning outcomes.

The benefit of this course is that it will provide the student programmer a strong understanding of converting clinical data into SDTM format by understanding the required modeling of the General Observation Class and targeted domains. The student will profit by understanding the components included in define.xml v2.0 as well as the process of third party validation of the define application. The student will have the advantage of learning how to resolve and apply corrective measures to ensure their modeling is in compliance with the SDTM standards. In this industry, these are desired skills.

Who Should Take This Course

This program is for SAS Programmers with or without prior experience and knowledge of SDTM. Upon successful completion of this course, the SAS programmer will have gained a level of expertise to draw upon when engaged in real-world projects.

Duration and Prerequisites

A total of 8 weeks is needed for completing the program.

Education and/or Experience
Students must possess a baccalaureate degree and will possess a working knowledge of Base SAS.

System Requirements
Personal computer with Windows® 7 or later; or Mac OS 10.8 or later; and 2 GB available storage for files. Citrix Client installed.

Assessments
Knowledge checks will be performed through a quiz in every session. Evaluation of written reports will be performed through multiple assignments/exercises and will conclude with a final examination. A minimum of 75% is required to pass the final examination.

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