X
sae reconciliation process

By Ethical 23 Jun, 2020

The SAE Reconciliation Process: A Multi-Facet Challenge

The SAE reconciliation process can be summarized in four - apparently easy - steps: retrieve and compare data, analyze the discrepancies, resolve the discrepancies and make the necessary adjustments in the clinical or safety database. But the process is more complex than it seems as it requires a thorough management of the numerous tasks involved, especially as all decisions and actions must be fully documented for GxP-compliance.

the sae reconciliation process

The SAE reconciliation process is driven by a Data Manager who, on a periodic basis, reviews data in the clinical database and compares defined variables with the corresponding records in the safety database. Verbatim descriptions, coding terms, dates and other information are frequently found to be different between the safety and clinical database and some SAEs maybe missing in one or the other database. Data Managers or CRO responsible Data Managers collaborate with Drug Safety for resolution.

An SAE-Reconciliation meeting is often necessary to discuss the discrepancies and determine if they are acceptable or decide on the appropriate course of action.
In most cases, queries are sent to sites for clarification or, in case of a Preferred Term (PT) inconsistency, the PT is discussed with the Study Responsible Physician or Safety Surveillance Physician.

Clinical monitors are in close contact with the investigational sites throughout the SAE reconciliation process and may be involved in query resolution and corrections. When the query response provides information that requires update of the safety database, a sponsor-specific GxP compliant process is followed for the update.

All decisions and actions must be documented. If certain data-points are not fully matching, the explanation for the discrepancy must be documented as well.

As a study progresses towards the end, the number of SAEs increases and the reconciliation activity becomes more intense. This is when the use of a GxP-compliant automated tool like Ethical eReconciliation offers competitive advantage by helping to save time while guaranteeing the quality and compliance of the SAE reconciliation process.

 

DOWNLOAD NOW THE FREE SAE RECONCILIATION HANDBOOK
The Manual / Reference Book with all the topics related to the Safety Data Reconciliation Management.

Archives

Download Ethical eReconciliation for SAE Reconciliation Dossier

eReconciliation
 
®
Solution Description

DOWNLOAD NOW

Request a Demo of the eReconciliation® Software

We are EU-GDPR compliant: Your Data will never be used improperly



SAE Reconciliation Process Checklist

SAE Data Reconciliation
Process Checklist
Free Download

DOWNLOAD ↓
Previous Next

Quality of SAE Reporting: A win-win situation with SAE reconciliation

Quality is a key component of all aspects of clinical trials and many processes are specifically designed to ensure quality and reliability of the data

SAE reporting qualityREAD MORE

Sae Reconciliation Of Short Vs Long Studies: The Importance Of Continuity And The Burden Of Repetition

Short studies are easier to manage from many aspects, long studies need to cope with periodic repetition of the same tasks run by different staff due to unavoidable turnaround.

 

sae reconciliation for long and short studiesREAD MORE

Adverse event reporting. How much can EDC do?

With the broad adoption of electronic data capture (EDC) technologies, some sponsors are testing EDC as a solution for tracking and reporting SAEs. But how good is EDC in drug safety reporting?

sae reportingREAD MORE