Is there Data Consistency between your SEND Submissions and Study Reports?
As a Sponsor or a CRO, you know how important it is to assure data quality in your FDA submissions. Your processes to package SEND datasets are likely being designed ensure compliance with the CDISC Standards and FDA Specific SEND Validation rules.
However, will they assure consistency with the data in your final Study Reports? And will they assure completeness, accuracy and consistency across study domains needed to support medical reviews?
High quality, standardized SEND data is critical for medical review of sponsor submitted datasets using NIMS. SEND datasets will be mandated for electronic submissions, but they are not the authoritative record of the study. That status belongs to the Study Report signed by the Study Director. When FDA reviewers find discrepancies in a SEND dataset or observe signals of interest, they will likely cross reference it against the Study Report.
The consequence of having a SEND file that does not match the Study Report can be devastating. It can delay the progress of your NDA, BLA or IND submission. Major discrepancies may result in studies being returned to the sponsor for additional checks and re-submission adding to delays. This may also raise questions about your data quality assurance processes.
Attend our upcoming webinar to learn more about this emerging “hot” topic and what you can do to ensure data consistency between your Study Reports and SEND datasets.
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