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SAE Reconciliation
soumyapottola@gmail.com | https://clinicalda.blogspot.com
Definition
SAE data reconciliation is 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.
Why sae reconciliation?
Primary reason 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.
Steps in SAE Reconciliation
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
2.Compare the SAE data 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)
continues…..
f. Outcome
g. Seriousness criteria
h. Relation to the drug
i. Action taken with study drug
From Demographics (DM):
a. DOB b. Age
c. Sex d. Race
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
3.Take appropriate action needed 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
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.
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
Sae reconciliation Flow chart
SAE collected from
clinical trial & marketed products
Reporting containing SAE Case Goes to safety
department
Case of adverse effect
continues…….
During clinical trial=SAE information 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
During information following information 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
Serious adverse event
Patient Drug 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
Need of SAE reconciliation=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
● 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

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SAE RECONCILIATION in clinical data management

  • 1. SAE Reconciliation soumyapottola@gmail.com | https://clinicalda.blogspot.com
  • 2. Definition SAE data reconciliation is 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? Primary reason 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 SAE Reconciliation 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 SAE data 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. Seriousness criteria 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 action needed 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 Flow chart SAE collected from clinical trial & marketed products Reporting containing SAE Case Goes to safety department Case of adverse effect
  • 12. continues……. During clinical trial=SAE information 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 following information 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 Patient Drug 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 SAE reconciliation=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