In addition to individual and dependent field validations to minimise errors at data entry, for Phase III studies other routines ensure that each record form is complete, that the user is made aware of which data is being committed to the analysis dataset, and that the person submitting the forms is appropriately authorised. Entries in the analysis dataset remain available for change by the submitting centre with superseding values forcing both re-signing and the recording of a reason which are entered in the audit trail.
Monitors can attach Data Clarification messages to the relevant submission. These are highlighted in the Overview screen on the data entry machine.
Post Marketing Surveillance studies benefit from a different approach. The reduction in mandatory requirements, with contributing centres compensated for each study form submitted, requires a streamlined data submission process. Reports of forms sent and waiting sign off, are created to inform users and feed information to sponsors’ payment systems.
Despite ongoing initiatives, methods and styles of adverse event reporting remain country specific. At present a combination of structured fields and free text narrative is the most popular with an emphasis on systems alerting designated individuals “as quickly as possible”, when Serious Adverse Events are recorded.
When certain data is entered after initiation of specified medications, for example additional diagnoses or an unexpected reduction in the primary medication dosage, a prompt can be displayed so that reports are actively elicited.
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