Download G3P - Good Privacy Protection Practice in Clinical Research by Karl-Heinz Schriever, Markus Schröder PDF

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The main steps of the whole validation process should always be essentially the same, independent of the different kinds of systems to be validated. Systems already in use but not yet validated (legacy systems) require a slightly different approach as totally new systems, normally starting from scratch. The validation process for individual programs may be performed by applying agreed programming and validation standards. All computer systems pass through a SDLC (System Development Life Cycle), including: – system initiation, – system development, – installation, – productive use, and as a final phase the – decommissioning, if no longer used.

4 Maintaining the Reliability of Stored Data When working with data, not only clinical and/or genetic data, you must guarantee that data used are free of logical contradictions. What does this mean? Well, during data entry, collected data are mostly either already available in a coded form or are being coded as part of the overall data entry process. The applied coding methods are on the one hand company or hospital internal coding standards and on the other hand internationally agreed coding standards of medicine like – MedDRA, – Medical Dictionary for Regulatory Activities – SNOMED, SNOMED CT, – Systematized Nomenclature of Medicine – Clinical Terms – WHO-DD – WHO Drug Dictionary 36 7 Anonymization Company or hospital internal coding standards are for example codes for gender or codes for ordinal scales, used to monitor pain and efficacy.

G. when applying a five point pain scale instead of a four point pain scale, the related pain variable must be changed, too. Nevertheless, these facts are often ignored. A variable MP (Morning Pain) recorded on a four point pain scale is not the same as a variable MP measured on a five point pain scale. Different pain scales require also different variables’ names. Use MP4 and MP5 instead of MP only. Variables having the same name, but being measured differently, must not be combined in an overall analysis.

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