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When Real World Problems Require Real World Solutions
Soon after starting a new phase 1 dose escalation study, Novotech Data Management team was notified by the Sponsor that the clinical site was unable to provide lab data exports in spite of earlier commitments due to technical issues at the clinic. The Novotech designed CRF was already in use with patients enrolling in the study, and there was no provision in it to capture lab data. Given the study was enrolling when this situation came to light, CRF redesign was not an option.
To deal with this scenario, Novotech Data Management quickly wrote a study specific SOP for the site, and provided training for manual entry of lab data under supervision into a commercial spreadsheet program. Upon transmission to Novotech, this data was then subjected to verification and 100% QC of all key fields, including crosschecks on all date and time points, out-of-range parameters and clinically significant results, assessed against AE/Med History entries in the CRF by Novotech’s medical monitor. A 10% random spot check of all lab data in the final database was also completed with an error tolerance level of 0.05%, which passed comfortably.
This rapid shift in study procedures, helped by oversight provided by the Novotech Data Management team at site level ensured all lab data were provided on time, and database lock was met ahead of schedule without compromising data quality or making any amendment to the CRF or database.
After all, there is no substitute for experience. |
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