Bookmarking the aCRF –
automating the manual labour
by Ramon Jakobs (with Kimberley Santing)
An integral part of any study submission to FDA is the annotated CRF. This annotated CRF must also be bookmarked. Bookmarks providing a concise overview of all forms and visits with hyperlinks to the associated page in the CRF for easier reference. Adding these bookmarks is often a manual, labour-intensive task that is not only tedious but also very prone to errors and inconsistencies.
The bookmarks are effectively a single list split into two parts: 1) form then visit, and 2) visit then form. Rather than in a list, these bookmarks can be represented in a two-dimensional matrix, or a spreadsheet. This matrix is the basis of our solution.
This presentation will present a solution which significantly reduces the time and effort required to bookmark a CRF. It revolves around preparing the bookmarks outside the CRF (i.e. outside the PDF) and in a spreadsheet which resembles the schedule of assessments. A simple program (SAS, R, VB) transforms this information into an XML file that can be imported into the CRF and that’s it – your aCRF is now ready for submission!
An Approach to Standardising SAS Programming in Clinical Trials
by Kai Wanke (with Bas van Bakel)