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Sae reconciliation

 SAE Reconciliation


Serious adverse event (SAE) reconciliation is one of the critical activities in clinical data management & also an important activity for clinical data manager.




Let's explore.

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)
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 𝗮𝗽𝗽𝗿𝗼𝗽𝗮𝗿𝗶𝘁𝗲 𝗮𝗰𝘁𝗶𝗼𝗻 𝗻𝗲𝗲𝗱𝗲𝗱 𝗯𝗮𝘀𝗲𝗱 𝗼𝗻 𝘁𝗵𝗲 𝗱𝗶𝘀𝗰𝗽𝗿𝗲𝗻𝗰𝗲𝗶𝘀 .

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

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. 𝗗𝗲𝗹𝗮𝘆𝗲𝗱 𝗿𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴: this may lead to a backlog of events to be reconciled.

In many companies SAE reconciliations are now done automatically with set of programs & DM's will verify the output report from these programs for their accuracy and reconcile manually in case its needed.
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