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Clinical Programming Course Outline

Clinical Programming Project Training

Introduction to ICH E3
Key points in ICH E3 referring to statistical outputs production
ICH E3 additional considerations
Technical solutions
Introduction to Drug Development Process in Pharmaceutical Industry or Clinical trials
Learning about the general department structure of pharmaceutical industry, roles and responsibilities of programmer in the company
Discussing and Reviewing sample SOP's and Guidelines from a real pharmaceutical industry
Understanding clinical study and documents {e.g. Protocols, Case Report Form (CRF), annotated and electronic Case Report Form (aCRF and eCRF), Statistical Analysis Plan (SAP)}
Deriving analysis data sets or annotating derived variables
Generating customized clinical trials Tables, Listings, Graphs/Figures and Reporting ( TLF's)
Generating SDTM Datasets
Creation of Specification and annotations of SDTM Datasets.
Creation of Specification and annotations of AdAM Datasets.
Edit Check Programming


This project is focused on educating programmers in Pharmaceutical or Contract Research Organization (CRO) company
Each session in this training will be followed by solving examples and summarizing contents covered and trainees will be given actual Pharmaceutical data and exercise to work on. These assignments will be evaluated and graded for their improvement and perfection of tasks
At the end of project, professional resume will be created and mock interviews will be conducted