Validation of SAS Programs for Clinical Studies
For the approval of medication or other medical products, clinical studies are confronted with specialised requirements for the management and analyses of data.
This is, for one thing, a result of the „Good Clinical Practice“-guideline for the performance of clinical studies. However, since the management and analysis of data is a question of electronic records and automated systems, this too must be validated.
Course goal
The participants will understand the concepts behind software validation and electronic records, and how they apply to clinical studies. Furthermore, they will acquire specific approaches for the validation of SAS programmes. This course does not offer a complete in it self closed process model, as this should be established specifically for the organisation.
Prerequisites
The participants should have knowledge in the performance of clinical studies in accordance to Good Clinical Practice (ICH E6), as well as Programming with Base SAS (GKPRO or GKEP) and Macro Programming (MACRO) and/or equivalent experience with SAS programming.
Target audience
This course is directed at programmers and statisticians in pharmaceutical and research organisations who are involved with data management and/or data analyses of clinical studies, and use SAS for this purpose.
Module
Base SAS Software
Course content
- Introduction to Software validation according to ISPE GAMP 4
- Introduction to the processing of electronic records according to FDA CFR 21 Part 11
- Introduction to Risk analysis
- The use of SAS Software for clinical studies
- SOPs and programming guidelines
- Introduction to Software
- Tracing from data to results
- Saving of data, programmes and analyses results
- Modular programming
- Quality assurance and documentation
- Development of standard macros
- Specification and documentation
- Testing
- Error handling
- Version management
- Qualification of the SAS installation with SASIQ and SASOQ
Duration
2 Days
Code
PHVALID
Registration
As a training partner of SAS we operate this course. For further information on our training offers as well as the individual workshops please contact training@analytical-software.de. If you want to book a course directly via SAS, please click here.