TED Reports will help you and your manager to better interpret your audit results, identify risks, and make informed decisions
A user guide and pop-ups are available to guide you through data entry. Complete the template by referring to your final audit report. First complete the general information describing the audit in 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 audit 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 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. The report shows the percentage of audit reports with a finding in each subcategory and gives an overall compliance index based on the number and severity of observations.
All reports are in pdf format and can be downloaded.
Each EMA finding subcategory is given a weighted score based on the severity of finding classification for that subcategory (0=no finding, 0.5=minor, 2=major, 5=critical).
The overall compliance index is the average of the weighted scores of all applicable subcategories (x), put into the formula exp(-x). A high overall compliance index indicates that your report(s) contained fewer and less severe findings than the benchmark sample.
The histogram depicts the distribution of the overall compliance indices for all audits included in the benchmark sample. 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 figure above, approximately 1% have a 75% compliance index.
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, toward the lower end of the yellow zone.
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.
This analysis compares the results of a group of audit reports selected by the user with the results of the benchmark sample. For example, you might select all of your audits conducted in a certain country, or all of your audits conducted in trials in a specific therapeutic area. The selection can be compared to the full benchmark sample, or filters can be used to further tailor 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 that have a finding in that category.
On the left side of the table (% finding classification user vs. benchmark reports), the red dot shows the average of the weighted scores (0=no finding, 0.5=minor, 2=major, 5=critical) for each subcategory for your selected reports, as compared to the average of the weighted scores for the subcategory for all benchmark reports. A high score here indicates more findings/more critical findings.
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.