SAE data reconciliation The process of comparing key safety data variables between the drug or device safety SAE database and the clinical database in order to identify any discrepancy, determine whether a discrepancy is acceptable or not and, if acceptable, document the discrepancy. It is an iterative process that occurs several times during the study. When to reconcile is determined by the frequency of data receipt, scheduling of safety updates and timing of interim and final reports. The objective is to reconcile all discrepancies before final clinical database lock in order to submit validated data to regulatory authorities. SAE discrepancy A mismatch between the safety database and the clinical database identified during the reconciliation process. A discrepancy can be for example: An SAE present in one database but missing in the other one Inconsistent SAE associated data between the databases Missing SAE associated data in one of the databases Mismatched SAE preferred term All the identified discrepancies, actions taken to address the discrepancies, and the status relevant to the action taken are recorded in the SAE manual or electronic reconciliation tool. Serious adverse event (SAE) report form Form used to report an SAE. An SAE report form contains information such as the event onset date, date that it became serious and end date, seriousness criteria (resulted in death, was life-threatening, required hospitalization, etc.), the severity (e.g.: mild, moderate, severe), the outcome (fatal, not resolved, resolved, resolved with sequelae, resolving, unknown), suspected drug(s) information and a causality assessment. (see also SAE reporting regulations). Suspected unexpected serious adverse drug reaction (SUSAR) A serious adverse reaction (SAR) for which a reasonable causal relationship with the medicine used is suspected but not confirmed. Unexpected means not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product or package insert/summary for an approved product). Trial Master File (TMF) The collection of the essential documents of a trial which individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced. TMSs are established at the beginning of the trial, both at the investigator’s site and at the sponsor’s office and are updated with new relevant documents as new information becomes available. Unexpected adverse drug reaction (UAR) An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational medicinal product or package insert/summary for an approved product). Serious adverse event or reaction (SAE or SAR) Any untoward medical occurrence that at any dose: results in death is life-threatening Safety database The database used by safety groups to process and manage SAE data from clinical trials

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