SAE RECONCILIATION in clinical data management

SAE RECONCILIATION in clinical data management

• 1.
  SAE Reconciliation [email protected] |https://clinicalda.blogspot.com
• 2.
  Definition SAE data reconciliationis the process of reconciling the clinical database (i.e. Data collected on the CRF) with the Pharmacovigilance database (i.e. SAE forms) to ensure the data is consistent and not contradictory. Serious adverse event (SAE) reconciliation is one of the critical activities in clinical data management & also an important activity for clinical data manager.
• 3.
  Why sae reconciliation? Primaryreason is to ensure the patient safety and integrity of clinical trial data, by comparing the SAE's reported between EDC and safety database for its completeness, accuracy & classification.
• 4.
  Steps in SAEReconciliation 1.SAE Reconciliation plan? This can be documented as part of DMP or it can be standalone document & It covers imp items like a. Process & roles involved in SAE recon b. List of items to be reconciled c. Process to report discrepancies d. Action to take to correct the data in both databases
• 5.
  2.Compare the SAEdata b/w 2 sources : Receive SAE dump or monthly SAE report from safety team & review the same for discrepancies in EDC data for the data points including From Adverse Event (AE) form: a. Protocol & Subject Number b. AE Term (Both reported terms & coded term) c. Severity Grade d. Start & End dates e. Death date (if any)
• 6.
  continues….. f. Outcome g. Seriousnesscriteria h. Relation to the drug i. Action taken with study drug From Demographics (DM): a. DOB b. Age c. Sex d. Race
• 7.
  From Concomitant Medication(CM) & Medical History (MH) a. Medication name / Medical condition / Surgery b. Start date c. Stop date or ongoing Indication From Study / Treatment Discontinuation (DS) a. Primary reason for discontinuation being an event b. Cause of hospitalization c. Cause of death listed on the death certificate d. Autopsy result
• 8.
  3.Take appropriate actionneeded based on the discrepancies Lets see the major SAE reconciliation Errors found in SAE Reconciliation 1.Data entry errors: This can occur due to human error, transcription errors, or incorrect data entry fields. 2.Incomplete data: Incomplete SAE data can occur when events are not recorded in both the EDC and safety databases
• 9.
  continues…….. 3.Inconsistencies in coding:SAEs may be coded differently in the EDC and safety databases, leading to discrepancies 4.Inconsistencies in Reporting: this can happen when different investigators or study sites use different terminology or criteria for reporting SAE 5.Delaying Reporting: this may lead to a backlog of events to be reconciled.
• 10.
  Adverse event :Any effect/disease Study Drug Patient Any Effect occurs INTAKE Adverse event Might may be Not might drug involved drug Adverse event maybe : MILD,MODERATE,SEVERE
• 11.
  Sae reconciliation Flowchart SAE collected from clinical trial & marketed products Reporting containing SAE Case Goes to safety department Case of adverse effect
• 12.
  continues……. During clinical trial=SAEinformation also received through CRF or EDC stored in ADVERSE EVENT DMS Stored in clinical & safety database Important to match SAE with data management system SAE Reconciliation
• 13.
  During information followinginformation are checked: 1. Cases found in the SAE system but not in the CDM system—- >(case of adverse effect)safety system. 2. Cases found in the CDM system but not in the SAE system — >(adverse event)database system. ● Death —>any case—>found only one system–>.(cases of adverse effect) adverse event
• 14.
  Serious adverse event PatientDrug Adverse event Results in death • Is life threatening, or places the participant at immediate risk of death from the event as it occurred • Requires or prolongs hospitalization • Causes persistent or significant disability or incapacity • Results in congenital anomalies or birth defects • Is another condition which investigators judge to represent significant hazards
• 15.
  Need of SAEreconciliation=compare SAE with CDM TABLE SAE CDM Less organized more organized/defined data: eg: Subject & investigate ID subject,investigate well defined in study data such as age, sex information Collected information but collect only events collected separately adverse event are collected event by event passociate each problem
• 16.
  ● Companies reports& manual comparison SAEreconclliation ON ● When the reporting system has access to the underlying database It might be possible to do initial match on some information such as study ID,Sub ID etc… Underlying database present in SAE system and CDM system. DEPENDS FOR