5 Takeaways: Data conversion
- The results of plausibility checks can be logged as a data query within an electronic data capture system to alert and communicate with site staff, and to track the status of the query from open to closed.
- Plausibility checks can inform what protocol deviations are logged - a full, final list is sent to the Sponsor of the project for their review before datalock.
- CDISC works closely with regulators all over the world to ensure their standards are appropriate for regulatory bodies, including the TGA, FDA, PMDA, and NMPA.
- Metadata is information that describes a particular database. This includes information about what each dataset contains, what each variable represents, and a data modification audit trail.
- The data listings are also included as Appendix 16.2 of a clinical study report as part of ICH GCP standards.
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