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LabCheck - Reconciliation
With some studies containing 100,000s of lab samples, do you ever wonder if all required tests were performed per protocol? Have laboratory protocol violations been thoroughly collected with so many samples in the mix?
Were more tests than necessary performed? How do you know a site is not compromising patient safety by not requesting safety labs, and how can you be proactive as a sponsor?
Due for release in 2023, LabCheck will compare the protocol schedule of events and lab test requirements against the laboratory dataset of any data source. Periodical review does not result in ‘double-data review’ because - as with all Apples & Oranges tools - a special proprietary VBA proc-compare is run each time. The user-friendly interface makes for easy navigation and an ability to highlight struggling sites in an instant..
The interface is dynamic, clickable throughout, with issues explained in human text. Think of it akin to a data management query system, with the ability to copy issue text...
Working towards a critical deliverable? Or a focus on specific countries or sites? Easy - LabCheck has data cuts by visits or by dates and can be filtered however the user wishes...
If you want to change the layout, filter rows or move columns, or simply have more or less information, the dynamic interface is your friend...
Boasting a range of exportable & dynamic charts and graphs makes for easy meeting preparation, in addition to being able to export both graphics and tables. This can be especially useful for sharing over secured networks for site monitoring visits, for example...
HOW DO I GET STARTED?
LabCheck can be purchased on licence later in 2023 and will simply run on your existing Microsoft Office installation. Once downloaded, the user can import the laboratory dataset. The user then completes a simple mapping table to command the program to the column location of the visit ID and lab test code ID, in addition to results if desired. Then with dropdowns of visit IDs and test codes, the user simply completes the mapping table to mirror the protocol schedule of events. This is a one-off activity, but could be repeated in the event of a protocol amendment requiring new tests. And that's it; watch the program run over the entire lab dataset in seconds. This unique approach leaves our clients with studies run far more efficiently, without a programming lag since this method will run on ALL data sources. Quite clearly, there is a resource cost-saving in an instant.
I NEED TO DO THIS KIND OF REVIEW EVERY MONTH. HOW DO I KNOW WHAT I HAVE REVIEWED ALREADY?
Importing a new lab dataset, any UNCHANGED records will remain as per your last edit (eg, ‘Clean’, ‘Open’ or ‘Pending’), unless a previously-missing lab sample is now present in the lab dataset, in which case it will close automatically as a now-clean record. As you can guess, you are attending to demonstratable, documented, continuous, risk-based monitoring needs in an as near-automated manner as possible. You are also keeping track without re-review, scanning 100% of all records, in addition to maintaining a permanent issues list and, thus, potential laboratory PV list...
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LabCheck is a tool under development and some images of the tool, or contents of this page may change as the tool nears go-live.