I have been working with a company called Patient Profiles for the last few months, and really wish I had found them earlier. I am really quickly becoming a bigger and bigger fan of the software, particularly as I delve more into Risk-Based Monitoring. So please excuse the shameless plug, but some things are just too good not to share.
Last week, I sat in on the ACRP sponsored webinar "FDA/EMA Inspection Lessons: How Adequate Monitoring Can Reduce or Avoid Findings". The main focus was on warning letters received by Investigators, Sponsors (and/or CROs), and IRBs and how better quality monitoring could have mitigated or avoided the warnings all together. Throughout the presentation there were multiple points that were discussed, and these were clearly areas where Patient Profiles and QueryMap (especially when used together) could have been really useful.
The presenter broke the warning topics into Investigator, Sponsor and IRBs. While we can’t do much on the IRB side (but I didn’t say nothing), where we really can make a difference is on the Investigator and Sponsor findings. Here are some of the items where the Patient Profile and QueryMap solution could have really made a difference.
On the Site/Investigator level:
1) Subjects not meeting Inclusion/Exclusion criteria - It was brought out how site specific metrics are extremely helpful. Being able to clearly see the inclusion and exclusion criteria in a Profile and better yep, flagging all the Profiles that did not meet inclusion/exclusions criteria and were still enrolled is so easy to do! And definitely something that would be easily flagged within QueryMap. This may not necessarily be a data monitoring, but certainly something a sponsor would want to catch as early as possible to review and take appropriate action.
2) Inconsistencies or Inaccuracies with documentation of dates - We definitely have this one covered! Timelines in a Profile are perfect for being able to visually spot these, as well as the Portal reports. Even better, line up your timelines for AEs, ConMeds and Study Visits and you can quickly identify the what doesn’t fit with the others!
3) Falsified Data - Need to be able to flag inconsistencies (or too much consistency) sooner, we have this covered as well. Using QueryMap to automatically analyze the data and “cluster” subjects that are similar to each other, makes spotting these so easy! QueryMap groups the similar subjects together, so when a subject in a cluster isn’t quite like the rest, its easily flagged. And of course if you end up with subjects that are just “too” similar, its quick and easy to see if these are all from the same site and could be falsified or fraudulent data. And with being able to run QueryMap with a relatively low number of subjects, it can definitely detect these earlier and you do not have to wait until on-site SDV notice it. It still may trigger a site visit however, and in this case you would likely want to do 100% SDV at that specific clinical site.
4) IRB approved ICF not current - Including the date of consent and the version date of the consent form (if available) is an easy way to flag this fraudulent activity. The CRA (central or field) will have copies and confirmation of the actual approval dates of ICFs from the IRBs. And the Profile can even include a flag if the dates are inconsistent.
5) Out of Visit Windows - Again, with the visit table in the portal, this is a great way to visually spot these easily! Color-coded visit tables, how much easier can it be?
Side point that came up from another aspect of the presentation, with the reduction of SDV for the study as a whole, it allows CRAs to be more focused on the procedures and processes that are not necessarily captured in the CRFs, thereby improving the overall study quality, not just the data. How great is that?!
The 1 applicable warning for Sponsors was the issue of the Sponsor (or CRO) not following the Monitoring Plan that was designed for that study. This is something we need to be, and can be, very helpful with. Anyone who has talked to me lately can tell you how much time I spend thinking about ways that the use Patient Profiles and QueryMap can incorporated into a monitoring plan. I am busting at the seams on this one! With a built in data quality scorecard, number and types of errors identified, QueryMap really does fit perfectly into a monitoring plan.
Personally the best line from the webinar that really does sum up RBM: It not less monitoring, its smarter monitoring. And that really is what RBM is about, and where Patient Profiles and QueryMap really make a difference. Whether a company is using an RBM approach, sticking with traditional or their data management team is looking for cleaner data, the Patient Profiles & QueryMap combination lets the data do the work and is definitely a smarter approach to data monitoring.
Thought I would share, and would love to tell you more!
- Meredith