Contemporaneous PDFs

Why doesn't the form PDF match what I see on my screen?

From time to time we receive this question from our users, almost always from the Monitor or Data Manager, but occasionally even from a member of the site staff.

The quick answer is contemporaneousness. The regulatory authorities require that data be contemporaneous, and the PDFs produced by Viedoc reflect this by showing the form as it was seen by the Investigator (or other site staff if delegated) when the form was last saved. This enables the authorities to see exactly what the Investigator saw at that time.

And this is why it can differ from what another user sees on their screen.

For example, one of the most common questions we receive is why the subject’s randomization number is not visible on, say, the demographics form for the first visit. This question comes up when the Monitor is reviewing a patient before an upcoming site visit, or when a Data Manager is reviewing data from the first X visits. The reason why the randomization number is not shown on the PDF produced when the demographics form was completed by the Investigator is that it was completed before the subject was included in the study – that is, before the subject had a randomization number. It is the contemporaneous version of the data seen by the Investigator at the time the form was saved. If the form is updated after the subject has been randomized, then the new version of the PDF will include the subject’s randomization number.

Another example is when the visit date is changed. The PDFs will show the visit date that was in force when the form was completed, not the new visit date if it was changed after that. However if the Investigator edits the data on a form after that and saves it, then the PDF for that form will have the new visit date, while the other, unchanged forms will still show the old visit date. This can seem confusing, but from a regulatory point of view it helps them identify that the visit date was changed after the data was entered, which might be important from a compliance point of view.

Queries can also lead to confusion. Open queries can be seen on the screen, but these are not reflected in the PDFs even if they were last saved while the query was open. The reason for this is that query handling is a separate process and is logged separately in Viedoc – you can download the full query history showing when queries were raised, resolved, and closed in an Excel file that allows you to sort and filter the queries and gives you a more complete history than the information shown on the screen.

Some customers have mentioned that there are other EDC systems that don’t work this way – that create all the PDFs at the end of the study, and then they are in agreement with what can be seen on the screen. The regulatory authorities have inspected clinical trials using other EDC systems that produce PDFs in this way, and given critical findings to systems that do not produce contemporaneous PDFs.

So by using Viedoc, you know that you will always be compliant with regulatory expectations regarding contemporaneous PDFs of the eCRF forms.