Tuesday, April 22, 2014

Risk based monitoring: Where is it today?

At Partnerships in Clinical Trials,Alison Taber, Vice President, Global Data Management, at
Theorem Clinical Research and Mitchell Katz, Executive Director, Medical Research Operations, Purdue Pharma L.P sat down with Medidata to discuss the the panel Risk Based Study Management for Small to Midsized Companies that took place on Monday, March 31.

During this conversation, they looked at the current enthusiasm for risk based monitoring but have seen that implementation and finding a universal meeting across the industry are some of the current biggest challenges that companies in the space are facing today.

Watch the video:

Head over to Geeks Talk Clinical to find out more about this panel.

1 comment:

janetclewis said...

Thank-you for your comments. I think it is important in all of these discussions that the site is a key player in risk based monitoring. The site needs to be aware exactly of the companies monitoring plan because it will fall back on to the site to monitor what the sponsor or CRO has not monitored. Risk based monitoring sounds great from the sponsor or CRO side but it puts the burden back to the site. In an FDA audit if a site missed something in error and it was something that was not included in the “monitoring plan”, it will be the site that receives the 483. It will also fall back on a CRA if something is missed due to Risk Based Monitoring. I am sure the sponsor will say, ”How was that missed”? I don’t think the site or a CRA will be able to use the excuse, “oh, that was not in the monitoring plan to do 100% source verification or some other reason”.
After going through many audits for high enrollment the FDA has looked at all data points of a certain percentage of patients. That may be a totally different set of patients that the sponsor looked at. As a site, I feel the more eyes the better. More monitoring, not less. I feel sorry for CRA’s that are expected to complete so much in so little time. Gone are the days where they can spend enough time at the site to actually complete the monitoring plan. I know the FDA supports risk based monitoring but when they do an inspection, I have not seen them follow a risk based inspection plan.