Welcome to the Engaged Database (TED)
Your access to a straightforward tool based upon the European Medicines Agency (EMA) inspection database.
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What is the Engaged Database?

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.

Introduction to The Engaged Database (TED)

 

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Why is TED relevant for you?

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.

How is this achieved?

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.


My Reports

How do I enter my data?

A user guide and pop-ups are available to guide you through data entry. Complete the template by referring to the 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

What does the report show you?

Each analytical report plots your audit results against other benchmark audit results of the same audit type (e.g. all 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.

How is the average compliance index calculated?

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 shows the percentage of benchmark audit reports that have the corresponding compliance index shown on the x axis - for example, 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. The color-coding allows you to see at a glance whether your compliance score is amongst the better results:

red     = lowest compliance index
green = highest compliance index.
In the example above, My Report had an overall compliance index of 86% which, when compared to the other reports from the same audit type in the database, was neither in the red zone of approximately 55-80% (the lowest scores) nor in the green zone of approximately 90-100% (the highest compliance scores), but lies somewhere in the middle field.

When I compare a single audit report?

The scale on the right shows the percentage of benchmark audit reports that have one (or more) findings in each 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 benchmark sample, 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 the same information in numbers: 4 out of the 381 benchmark reports had a finding in this category. Of these, 3 were rated major and 1 was rated minor.

When I have multiple audit reports?

This analysis compares your selected audit reports with the benchmark sample. The red dot on the right side of each row depicts the percentage of your selected reports that have a finding in that category/subcategory, compared to the percentage of benchmark reports.

On the left side of the table (% finding classification user vs. benchmark reports), the red dot shows the average of the weighted scores for each subcategory for your selected reports, as compared to the 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 in the first subcategory vs. 29% of the benchmark sample.
On the left hand side: the average weighted score for that subcategory for "My reports" is approximately 40% vs. an average weighted score of the benchmark reports of 31%.

Therefore, while fewer of my reports had a finding in this category, the rating/classification of those findings in "My Reports" was higher, i.e. more critical, than in the benchmark sample.


Benefits for you?

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, while 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.


Like to use TED before registering?

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.

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What does TED cost?

The annual subcription rate of € 3000 or US$ 4000 provides unlimited access to TED for one year.
You can pay using PayPal or most major credit cards, or you can wire the annual registration fee.

Subscribe to TED! Today! Right Now!

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 will be. We invite you to explore the possibilities that TED has to offer.

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If you already have an account with us, please login at The Engaged Database login page.

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Please register now, the database is only a few clicks away!

  • TED contains hundreds of audit report results from the year 2009 to date
  • TED reports all use the same EMA categories and EMA classification criteria
  • Your own audit result – you will be able to see it in no time

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