Friday, December 24, 2010

Reconciliation of the Serious Adverse Events

Reconciliation of the Serious Adverse  Events


3.1 Reconciliation of SAEs captured during the conduct of clinical research trials and SAEs recorded in the Safety Database will occur several times during the lifecycle (the conduct) of the clinical research trial. 
3.2 Timing and number of the reconciliation cycles will be determined by the frequency of data received, the scheduling of safety updates and the timing of interim and final reports to regulatory authorities on serious adverse event findings.
3.3 The capture of SAEs in both the clinical trials database and the safety database should be standardized with regard to data captured and coding of terms (e.g., event description, start and stop date, relation to study drug, verbatim term coding, etc.). 
3.4 All information (data and metadata elements) to be reconciled during this procedure shall be identified and documented in the study plan before the first patient is enrolled in the clinical research protocol.
3.5 A cut-off point will be identified in the study plan, after which, no SAEs will be added to the clinical research database, even if the safety database is updated. 
3.6 Changes to either database, as a result of reconciliation activities, will be made in a timely manner to expedite clinical study closure activities and/or safety reporting requirements.
3.7 Local QA formally conducts a review of the reconciliation results for accuracy

Study Coordinator
Work with the Drug Safety Officer and the Clinical Research Study Team to reconcile SAEs captured in the clinical data management application with SAEs captured and recorded in the Safety Database.
Make the necessary changes and/or updates to the clinical data management application.
Drug Safety Officer
Assist in reconciling SAEs in line with this SOP
Make the necessary changes and/or updates to the Safety
Clinical Study Team
Provide the necessary clinical information or interpretation input on SAEs captured during the conduct of the clinical research trial, including input on coding of events
Local QA
Conduct a formal review of the reconciliation processes and performs a quality check on updates to the databases.

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