Clinical Data Management organizations should heed the call to focus on what matters as they revamp their data review strategy. This topic brief highlights opportunities resulting from the evolution of our discipline in the context of the 5Vs of Clinical Data (Volume, Variety, Velocity, Veracity and Value) covered in detail by the SCDM topic brief released on April 26th 2022.
In the past few years, key stakeholders such as sponsors and regulators have noticeably shifted their attention toward critical data and processes. In such a context, it would no longer make sense to continue applying a consistent level of clinical data review across all data. By equally focusing attention to all data the same way, we cannot focus on what matters which really means that we are increasing the risk of not identifying data quality gaps on critical data during our data reviews.
It is also critical to realize that in some cases, it is possible that data integrity is reached for some data streams but not all. However, data quality can only be reached when all data streams together demonstrate the credibility and reliability of the trial results (i.e., outcome focused).
Last but not least, the scope of data review within a risk-based CDS study execution goes beyond patient data and includes the interrogation of the audit trails which contain precious information on how the protocol is being operationalized and the way in which data is being collected. This information is relevant to both the integrity and quality of the study data.
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