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Central data management

 

If you perform a multicenter study, you can perform central data management. Central Data Managers monitor data centrally (usually from the coordinating center), but do not perform Source Document Verification (SDV). In other words,  they do not verify whether the data in the CRF matches the data in the patient charts. In fact, they check whether there are inconsistencies between different values in the CRF fields. They can for example also check manually the quality of the data (missing data, time points out of window etc.). To a certain extent these checks can also be implemented as automated validation rules (electronic checks defined in advance which ensure the completeness and consistency of the clinical trial data), but some data requires the eye of an expert. For electronic CRFs the validation rules may be applied in real time at the point of entry. Offline validation may still be required (e.g. for cross checks between data types).

Unfortunately, central data management is not fully supported in OpenClinica. There is no  “Central Data Manager” role within OpenClinica and no module that allows to indicate which CRFs have been checked, apart from the SDV module.  Also navigating from one CRF to another is cumbersome.

To work around these shortcomings it is advised to keep a Word or Excel document in which you record which CRFs have been checked (see an example attached).

 

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