CRPDReconciliationofSAEEvents.docVIP

National Cancer Institute Procedure DescriptionSUBJECT: Reconciliation of the Serious Adverse Events Database under the caBIG? ProgramSOP No.: CR-007Version No.: 1.0Issue Date: 10/31/2005Page  PAGE 2 of  NUMPAGES 2 Pages StepAction1Study Coordinator initiates reconciliation activities with the Drug Safety Officer. Before initiating the reconciliation process, the Study Coordinator confirms that all data to be included in the reconciliation cycle have been entered; that any data queries or clarifications have been returned and clinical database has been updated with the changes; and that the coding of the adverse event verbatim terms against the common dictionary has been completed. The Study Coordinator and the Drug Safety Officers should establish a mutually agreeable turn-around time for researching, retrieving, correcting and documenting any discrepancies found during or since the last reconciliation cycle. 2Study Coordinator obtains SAE listings from both databases and begins reconciliation activities. Obtain report listings of SAEs from the Safety Database for reconciliation (Note: Listings may be generated by patient, protocol and/or study drug or device information). Ancillary documents (e.g., hospitalization discharge summary, death certificate, autopsy report) may also be used for clarification during the reconciliation procedure. Verify that all the SAEs captured in the clinical trial database also reside in the Safety Database. (Note: Some SAEs from the Safety Database may not currently be recorded in the clinical database until all CRFs are collected and entered.) Document all SAEs that are in clinical database but are not recorded in the Safety Database are listed on the SAE Reconciliation Form. Include copies of the appropriate CRFs and forwarded them to the Drug Safety Officer for review and research. Document on the SAE Reconciliation Form all SAEs in the Safety Database that are not currently in the clinical