Most of the Annotated CRFs I have seen over the years were the product of a manual annotation process. As a result, they were mostly not error free and, probably due to the effort involved, were not always updated when the underlying database was. As part of these CRFs originated from non-DataFax studies, it is understandable why they were created using manual labor.
Most of the ‘other’ clinical trial database management systems do not know where each variable is located on a CRF page. Luckily with DataFax, it is a different story, in order for the OCR to work, DataFax needs to know exaclty where each item is located. In fact, if you have an item spanning several groups of boxes, DataFax even knows the location of each individual box. And as the developers of DataFax have been kind enough to store all relevant information in readable files, it is possible to retrieve information on both Variable names and their position, and to automate the process of creating an Annotated CRF. I know that there are several DataFax clients who have been doing this.
Once the process has moved from manual to a kind of automatic (you still need to push a couple of buttons), the Annotated CRF can serve the whole process, rather than being a kind of boring nuisance. That is, now that the Annotated CRF is created automatically, you can assume that it is error-free, so others, like Biometrics, can rely on it. Also, as the process is automated, it is relatively easy to include things you hardly ever see in a manual created Annotated CRF, like including meta information. Things like different colour coding for Required/Optional Fields. Or including the DataFax Field number. Which makes the Annotated CRF extremely helpful when creating a SAS export (where you will refer to a Field being exported by its Field number).
And when this Annotad CRF is combined with information from the Visit map, different Bookmarks can be created to allow different indexes to the CRF pages. So a Study manager can easily open a Bookmark for say Visit 2 and see which CRF pages are part of that Visit. Or a Statistician can open the Bookmark for a Lab page, and see from which Visits this information is being collected.
And one step further is to combine it with other sorts of information, like your export to SAS datasets or to CDISC/SDTM Domains. At Thorin, we are using an application which allows us to ‘map’ DataFax Plates & Variables to SAS Datasets/Fields. Based on this ‘mapping’, it is possible to create a SDTM Annotated CRF, where the DataFax Field names are replaced by the SDTM Fieldnames, preceded by the SDTM Domain name.
So with this level of detail, the Annotated has moved from a boring Necessity to a powerful tool to open meta-information from a study to a larger group of people. And in my experience, not only to access the meta-information, but also to review it. And thus becoming part of the QA process.
