The Engaged Database, or TED as we like to call it, is a validated database housing a collection of audit results grouped according to EMA categories and subcategories with observations graded according to the same 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 based upon the European Medicines Agency (EMA) inspection database, which allows the comparison of the results of one or more audits to a large number of audit results.
TED is a smart solution, to save resources and help to avoid 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, who also owns 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 process to collect and capture audit data is sound and based on robust quality criteria and in compliance with scientific, legal and ethical standards.
The Engaged Database provides a global resource for all pharma, biotech and medical device companies, as well as acedemia.
TED contains hundreds of standardized audit results from 2009 to date.
With the information collected – you will be able to see in no time – 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.
A standard report is available to compare your audit result data with similar audits in the database. Filters, such as phase of trial, geographic area or observation responsible can be used to tailor the benchmark sample further. Descriptive statistics such as percentage of reports with observations in a subcategory vs my reports, or a compliance index provide you with a structured assessment at a glance.
A user guide and pop-ups are available to guide you through data entry. Complete the template by referring to the actual results of your audit. First complete the boxes at the top of the page, using the drop-down suggestions. When you have completed these, tick "yes" in the relevant subcategory line, for each observation you had in the original report. Then add gradings for "minor", "major" or "critical" as per EMA definitions and tick one item for "Relevance/Impact of the Finding" and then tick one item for "Responsibility for Finding". Finally, you import the data to the database and get your report statistics automatically.
You enter your data via a simple mask/template ↑
Each report plots your audit results against other benchmark audit results of the same audit type, (i.e. investigator site audits) already in the database. In addition, the report shows the percentage of audit reports with a finding in this category and gives an average compliance index on the severity of observations.
All reports are in pdf format and can be downloaded.
Each EMA finding subcategory is given a rating (weighted score) based on the severity of finding classification, (0=no finding, 0.5=minor, 2=major, 5=critical).
The calculation is the average of the weighted scores of all applicable subcategories (x), put into the formula exp(-x).
The y axis is the percentage of benchmark audit reports that have the corresponding compliance index - in the example above, approximately 1% have a 75% compliance index.
The histogram shows you the percentage compliance of your report(s) compared to the other reports in the database and whether your percentage is amongst the better results;
red = lowest compliance index, to
green = highest compliance index.
In the example above, My Report, had a compliance index of 86% which, when compared to the other reports from the same audit type in the database, was not in the red zone of approximately 55-80% (the lowest compliance indices) nor in the green zone, approximately 90-100% (the highest compliance indices) but is at the lower end.
The scale on the right is the percentage of benchmark audit reports that have one (or more) findings in the category/subcategory.
The red dot appears when there is a finding for this subcategory in my report.
The left side of the report shows the number of critical, major, minor findings for each subcategory, the number of reports with no findings for that subcategory and the number of reports where that subcategory is considered not applicable, in the database, for that type of audit.
In the example above "My report" has a major finding in the subcategory "Insurance/indemnity/compensation to subjects".
The right side of the report shows that only 1% of benchmark reports have an observation in this subcategory.
The left side of the report shows that only 4 out of the 381 benchmark reports had a finding in this category. Of these, 3 were rated major and one was rated minor.
The red dot refers to the percentage of my reports that have one (or more) finding in the category/subcategory..
On the left side of the table are % finding classification user vs. benchmark reports. This is the average of the weighted scores for the subcategory for "My reports" shown as a red dot vs. average of the weighted scores for the subcategory for all benchmark reports.
The example above shows:
On the right hand side 25% of "My reports" had a finding vs. 29% of the benchmark reports for that subcategory.
On the left hand side, the average weighted scores of that subcategory for "My reports" is approximately 40% vs. an average weighted score of the benchmark reports of 31%. Therefore, less of my reports had a finding in this category, however, the rating/classification of findings in "My reports" was higher.
Using TED, you are able to see at a glance where your audit result stands, in comparison with the anonymized results from other companies. TED can, therefore, help large companies to avoid a bias when interpreting their audit results, whilst allowing smaller companies to benchmark even if they only have very few audits of one type.
The detailed TED statistics can help you and your managers to better interpret the results of your audits and provide a factual basis to help in identifying potential risks, which in turn can lead to more informed decision making on a corporate level.
We have created a TED database of demo db data for you to use, to allow you to evaluate the potential of TED for your corporate auditing programme.
If you are an interested user and would like to set-up a test account, please get in touch with us. We will provide you with a link and log-in details for the demo db.
For € 3000 or US$ 4000 you will have unlimited access to TED for one year.
You can pay using PayPal, most major credit cards or you can wire the annual registration fee.
Each report that is added to TED enriches the clinical research community. The larger the sample size, the more robust the comparisons to your individual audit results. We invite you to explore the possibilities that TED has to offer.