During the second session, yesterday, at the FDA / PhUSE CSS meeting, the working group leads gave a quick round up of the work being undertaken by each of the groups and the current state of play.
The one item that caught my attention, due to the fact we have been discussing it in the last few weeks in the office, was the first release of a template for a Study Data Reviewer’s Guide. I wont say much more because all I would be doing would be repeating words on the PhUSE Wiki and that would be rather pointless. So go over to the page via the link, have a read and grab the download. Look in the “SDRG Deliverables” section where you will find a link to a zip file.
Within the zip file you will find the MS Word template and Completion Guidelines.