The list below contains examples where source data can be stored: these are the expectations for clinical trial documentation, but in reality, many problems are observed with regard to the quality of the source documentation. Systematic gaps in the documentation can lead to questions about data integrity, which could lead to the decision of health authorities to exclude data from the analysis. EU GCP inspectors do not prefer a specific solution, for example. B a third party, data printed before transfer to the database or simultaneous recording of a copy on the investigator`s local hard drive; The key point is that the choice of an electronic solution should not compromise the credibility of the data and should not lead to lower quality compared to a paper FIU. . . .

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Last Modified: outubro 8, 2021