I have a question that I would like to ask.
When Monitors go out onsite to carry out Monitoring activities, and, the monitoring activity involves working with the data captured into an EDC system – how do they do it if the EDC system is online only?
- They could use the site computer – but, often this is a computer shared for other purposes. With increasing security at site locations, often it is not appropriate for an external person to login to a site system.
- They could use their own laptop with the site network link? Using the site network infrastructure is often a big no-no. The site will often not provide a wireless network key, again due to security restrictions
- They could use their own laptop, but with a 3G or similar wireless technology? Well – not in many hospital establishments. Mobile communication, including 3G is not permitted.
So, without resorting to an offline solution, how do they work?