X
SAE Data Reconciliation Software

By Ethical 25 Aug, 2020

SAE data reconciliation software: Key elements to look for

Sponsors of clinical trials prefer to perform SAE data reconciliation during the course of their studies rather than waiting for database closure. By doing so, the risk to overlook discrepancies and the time to submission are reduced. But without the right tool, sustaining the pace of SAE data reconciliation over the time of a study can become a hassle for clinical teams. So, what can Data Management and Drug Safety teams expect from an SAE data reconciliation software?

The SAE data reconciliation process is more complex than it seems. Navigating back and forth between two databases to search missing SAEs and discrepancies and compare data that can change over time, coordinating operations involving different functions when staff comes and goes, tracking pending discrepancies at site-level or documenting all the study reconciliation operations for GxP compliance and audit are only a few of the challenges faced by Data Managers and Drug Safety Officers in this process. Another great challenge, and not the least, is of course time to submission. The sooner the clinical database is locked, the better. This is why sponsors prefer to perform their SAE data reconciliation sooner rather than later, even if teams have to track safety data updates throughout the study.

Performing those tasks manually is not only error-prone but also time consuming. No one wants to risk overlooking a missing SAE or a discrepancy. The quality risk is too great.

An electronic SAE data reconciliation software can help in many ways. One of the greatest benefits is perhaps the capability to record all the actions performed in the system in an audit trail, allowing to automatically document all changes performed in the safety or clinical databases. Such a tool, if well-conceived, will also make it easy to compare records from two distinct databases and search missing SAEs or discrepancies, detect changes in source data and spot the latest changes so that time is no longer wasted scrutinizing interim changes. It will also make it easy to manage all reconciliation-operations related tasks. Last but not least, a performing SAE data reconciliation software will be customizable at configuration to match the needs of a specific team and study.

In short, one should expect from an SAE data reconciliation software that it saves time, reduces errors and prevents major compliance breaks. Choosing the appropriate tool is therefore paramount to the success of your SAE data reconciliation.

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 eAdjudication for Endpoint Adjudication Dossier

eAdjudication®
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

Protecting safety of Patients with a robust adverse event reporting system

Monitoring of a drug’s safety profile in order to protect participants from unwarranted risk, relies heavily on the collection, classification, coding and reporting of Adverse Events (AE) during the conduct of clinical trials.

adverse event reportingREAD MORE

Serious Adverse Event Reconciliation & Reporting during a Long Study: Not a flat curve at all

Many changes are likely to occur during the study and the workload is likely to vary along the way in a long study. How should the SAE reconciliation process and tools be set to best fit these conditions? 

 

SAE Reconciliation Long StudyREAD MORE

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