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This trial will be supervised by a scientific advisory board including members experienced in assuring data quality and safety (DSMB).
But it is our view that provided a repository meets the criteria defining data quality and safety that are appropriate to the particular data it holds, all such approaches should have the potential to be viewed as a Data Safe Haven.
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In recent years studies not falling under the German Pharmaceutical Law ("non-drug trials") have also been increasingly expected to be conducted according to Good Clinical Practice (GCP) in order to ensure that uniform standards are maintained for data quality and patient safety.
The standards-based and technology-enabled single-source process proposed here can reduce transcription errors, increase efficiency, and facilitate information flow and timeliness of data, thus improving data quality and patient safety.
The DSMC will review the quarterly reports on recruitment, participant retention, study safety and data quality, and monitor study progress.
But just like the subprime bond market, much of the underlying data on quality and safety is hidden.
1 Initiatives and methods to collect data on quality and safety in primary care are still being discussed.
It contains the domains 1. Definition of a palliative care service, 2. Access to palliative care, 3. Infrastructure, 4. Assessment tools, 5. Personnel, 6. Documentation of clinical data, 7. Quality and safety issues, 8. Reporting clinical activity of palliative care, 9. Research and 10.
While sharing information like Medicare claims data around provider quality and safety recently released by CMS is an important step, it does not go far enough.
Much of the fellow's initial efforts will be devoted to electronic health records, clinical decision support, databases and data analysis, and quality and safety.
The increasingly complex healthcare landscape requires that organizations build effective data infrastructures to support quality and safety research.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com