Clinical Programming Project Training
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| 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 |
Objective
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This project is focused on educating programmers in Pharmaceutical or Contract Research Organization (CRO) company
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| 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 |