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?
3 comments:
Network availability for Monitoring visits should be one of the items on the site qualification checklist. If security policies at the site are so restrictive that a Monitor cannot get any kind of network access (including access to a POTS line e.g. from a Fax) then that site may be struck from the list of EDC sites.
Ironic that a site that is so technically advanced that it has good IT security policies should be excluded from an EDC trial.
But it would be very interesting to hear the experiences of field Monitors. Maybe someone will post here.
You will find that many clinical sites provide open access ports in "monitoring rooms" to permit effectively use online EDC systems. That type of access is even available in institutions with restrictive network policies after completing a round of paperwork.
Of course, online EDC tools work especially well when you learn that the clinical site gets their wireless access from the coffee shop next door (true story).
Thanks Steve. It may be the case, that the business demand is creating solutions such as you suggest. I can just see the latest Site Assessment forms.... 'Do you have a Starbucks within 300 yards? ... ;-)
For larger sites to effectively participate with sponsors, they need to be sponsor friendly. The smaller sites though still have a challenge.
It would be nice to be able to survey for a typical study of say 100 sites how the Monitors managed to carry out online SDV at the site.
That said, with the DataSci patent issue, and challenge of creating a truly robust hybrid online/offline EDC tool, the workaround solutions with online only may be the only way.
Post a Comment