The Engaged Database, or TED as we like to call it, is a validated database housing a collection of standardized audit results. Audit observations are coded according to the categories and subcategories used by the inspectors of the European Medicines Agency (EMA) and graded according to EMA criticality definitions. The data is fully anonymized using a numbering system for each audit, protecting the identity of the auditee/auditor. With TED, you as user have access to a straightforward tool which allows the comparison of the results of one or more audits to the results from a large number of audits from other companies.
TED is a smart solution which can help you save resources, identify risks, and prevent failure of research and development projects.
Find out how the results from your audit programme measure up against those of other companies. What do the results really mean, and what can you learn from them?
The Engaged Database is owned and managed by Dr Barbara Heumann, Owner and Managing Director of the independent auditing company GXP-Engaged Auditing Services. TED has a governance group made up of respected clinical research professionals from all over the world, who ensure that the processes for collecting and capturing audit data are sound, based on robust quality criteria, and in compliance with scientific, legal and ethical standards.
The Engaged Database provides a global resource for pharma, biotech and medical device companies, as well as academia.
TED contains hundreds of standardized audit results from 2009 to date.
With the information collected, you will be able to see immediately where your own audit result stands, compared to a larger volume of audit results already entered.
Each audit is entered into the database following the same set of EMA categories and EMA classification criteria.
An analytical report is then generated to compare your audit result data with similar audits in the database. Filters such as phase of trial, geographic area or therapeutic area can be used to tailor the benchmark sample further. Descriptive statistics, such as percentage of reports with observations in each subcategory, and graphs showing the calculated compliance index provide you with a structured assessment at a glance.