Risk-Based Monitoring with IRT

IRT Essentials

The key to effective Risk-Based Monitoring (RBM) is data – having essential information in your hands in a timely fashion.

Interactive Response Technology (IRT/IVR/IWR), which long ago had its start as a ‘randomization platform’ for clinical trials, is now a powerful tool-of-choice for subject and drug supply management, yielding data that can and should be leveraged as RBM support for clinical studies.

Good RBM enables study CRAs/PMs to monitor, without leaving their desks, the status of key project variables – i.e., variables that indicate potential risks that might require an enhanced response, like scheduling a site visit, focusing additional site training, or feeding back to decision makers issues and potential issues in study conduct.

When the Project Specification and the Project System don’t match…

Case Studies

Sometimes it’s a simple thing that gives quality management theory a challenge. For example:

Conventional practice for testing a clinical trial project system asserts the following: When tracing from a test result to the official Project Specification (PS), any discrepancy between the PS and the system requires failing the test step and then re-testing it again in a new test cycle after a correction interval. If we translate this assertion into other terms, the problem with this reasoning becomes obvious: The approach mandates that errors that occur only in the project specification document must result in failing the system – even though the system is perfectly correct. Impact on timelines and project costs are the unfortunate results of this convention.

A typical example: The PS for System XYZ, which outlines the setup configurations for the new project system, has an error in the table that describes the permitted treatment windows for each clinical visit. The PS says X plus or minus three days is permitted at Visit 2; the system is configured to allow four days. From client meetings and correspondence, it’s certain that four days is correct– that is, the system is entirely accurate. The only error that has occurred is that the team has forgotten to make the update to the project specification document prior to the start of testing.

Veracity Logic takes the following view in such cases: When there is certainty and collateral confirmation that only the PS document needs to be corrected, Testers are instructed to mark the test step as a Pass and open a new case in our Issue Tracking System for the required PS Update. A unique tracking number is generated for the case and a discrepancy note including this number is added by the Tester to the test case/step. The Validation Summary Report for the entire testing process captures both the number of Passed and Failed test steps and the number and location of PS Updates required to be corrected (and the PS re-approved) prior to releasing the system for Client User Acceptance Testing.

Meet VL at OCT Southeast 2017 in Cary, NC

Events, Newsletter Archive

This locally-focused event attended by the RTP biopharmaceutical market (and more!) looks at key challenges faced by small to mid-sized biotech and pharma companies in the Southeast and facilitates learning and problem-solving through case studies and discussion among peers. We’d love to meet up!

Enrollment Expectations and Site Management

Case Studies

Problem: Your clinical trial will be conducted at more than 50 clinical sites in the U.S. and another 40 internationally. The incidence of disease for the indication of interest varies widely based on geography, but your IRT algorithm treats sites as a unitary phenomenon–a sure path to cost inefficiencies. How can you leverage known statistical differences to control drug waste, shipping costs, and reduce problems with drug allocation?

Solution: As part of its CORE system, Veracity Logic’s IRT (IWR/IVR) includes the option to accommodate site diversity with respect to known enrollment thresholds. Clients can designate a site as an anticipated low, medium, or high enroller. For each enrollment threshold, users can specify differences in the initial drug allocation to a site, the baseline drug supply that is to be maintained at a site, and the alert levels which will let the system know when it’s time to ship more drug. IRT limitations no longer need to contribute to an overabundance of study drug at one site while the study team wrestles with an insufficient amount of drug at a site performing better. Site assignment to the low, medium, or high enrollment category can also be easily modified at any time the circumstances change.