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Home / Data Reconciliation Blog

Ethical’s BLOG

Stay connected to eReconciliation® news
and SAE Data Reconciliation in the eClinical World

Ethical’s Director Mimmo Garibbo and colleagues in Quality Assurance, Software
Engineering and Security bring you news and insight on issues, trends, technology,
developments and noteworthy events in the world of Clinical Data Reconciliation

reconciliation AI

By Ethical 14 Jul, 2022

Ethical is adding AI to its eReconciliation automation engine

The English language gives the possibility to describe the same thing in many different ways and even the highly regulated coding dictionaries such as MedDRA and SNOMED are very flexible and allow multiple terms when it comes to describing adverse events, medical history or concomitant medication. Which of these terms are equivalent? Which can be c...

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Excel for Reconciliation

By Ethical 14 Jun, 2022

Do you really use excel to reconcile critical safety data for your studies?

Serious Adverse Events (SAE) reconciliation is a crucial step in the pharmacovigilance process not only because it improves the study data integrity and quality, but also because it is a requirement for ensuring patient safety. This is an important aspect that health authorities have in mind during inspections and the main reason why auditors look ...

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AE Reporting

By Ethical 22 Mar, 2022

Five tips for data quality in AE reporting

In a clinical trial, the clinical database where all data are recorded and cleaned, using an elaborate system of query-answer, differs from the safety database which relies mostly on the narrative description of the serious adverse event by the principal investigator (PI) or other physician if the event occurred outside of the investigational site....

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sae reconciliation misconceptions

By Ethical 01 Feb, 2022

Five misconceptions about SAE data reconciliation

Misconception 1: SAE data in the safety and the clinical databases come from the same source so they are identical  While patient records are unique for each individual study subject, serious adverse event (SAE) data are collected in a very different way during the safety and clinical processes. Clinical data are recorded in the case report f...

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