Optimizing Timely IRT Compliance

IRT Essentials

A general finding in the clinical trials industry is that entering visit data into an EDC system by clinical site personnel lags, on average, 11 days behind a clinic visit. This issue of belated entry persists in the industry despite the hopes, dreams, wishes, urgings, and incentives offered by Sponsors and CROs for quicker data access.
Typically, IRT (IWR/IVR) systems, which provide clinical personnel with critical information like Subject IDs, randomization to treatment groups, and kit numbers for proper drug dispensation at site visits, enjoy timelier entry of visit data than do EDC systems. This ‘first-in/early data’ positioning makes IRT systems highly valuable components of a trial’s data collection efforts.

RBM in 2018

IRT Essentials

As the new year of 2018 begins, it does so with the transition to Risk-Based Monitoring (RBM) one of the key initiatives on the table for the clinical trials industry.
Backed by federal regulators, RBM urges a move away from ‘rote’ approaches to quality control – for example, 100% Source Data Verification — in favor of a variety of heads-up, algorithm-driven assessments of potential trouble spots, with preventive and corrective actions the key focus for study monitoring activities.
Veracity Logic (VL) has contributed to the RBM discussion in these hot topic pages on more than one occasion, highlighting some of the many key data points available first in IRT (IWR/IVR) systems, data that support the RBM initiative (for example: Actionable Intelligence from the IRT for CRAs or Risk-Based Monitoring with IRT)

Sites Are Not Created Equal

Case Studies


Why try to push a square peg into a round hole? It’s an old saw, but a true one: investigator Sites in clinical trials are widely different in their procedures, their facilities, their local challenges, their staff, their suppliers, their idiosyncrasies. How then does a Project Manager (PM) standardize important aspects of the trial — things like shipping and resupply processes, predictive algorithms, drug sourcing, and more?

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.

Help, I need to add a Site but the study hasn’t started!

Case Studies


You’ve got a study with 150 Clinical Sites globally and you want to be able to begin adding Sites to your IRT system as soon as they are enlisted (and allow Site Monitors to modify Site information as needed), but you don’t want Sites to be able to add Subjects until regulatory requirements are met. Once the study has started, authorized personnel should be able to add, modify, and remove Sites quickly and easily on an ongoing basis. How to do this?

Veracity Logic’s IRT solves the first problem by separating the Add Site function from the Activate Site function. Site information is added with the click of a button on the Sites page. At the desired point in the study startup process, the site is officially activated (by an authorized user). Once activated, clinical sites can begin to add subjects. Throughout the study, authorized users can easily access and modify site information as needed to keep site details up to date.

As part of the standard module, site information includes address, primary contact, phone and fax numbers, time zone, country, status as a clinical site or a depot, and whether the site will be resupplied using a manual, automatic, or predictive methodology. The warehouse supplying the site is specified, as is the maximum number of screened and randomized subjects permitted at the site.

Want to know more about the powerful standard offerings of Veracity Logic’s IRT?

Leverage IRT Capabilities for Site Monitoring

Newsletter Archive

Wide Range of Applications

VL’s IRT system delivers a wide range of applications for planning site monitoring visits during the life of a clinical trial. Our Subject Management module and Rollup Reports offer a variety of metrics on subject activities, drug dispensation, and other performance variables within and across subjects and Sites. Also, IRT data is typically available before it is entered into the clinical database …this gives Site Monitors an important heads up as they plan their next site visit! Serving sponsors, drug suppliers, and clinical sites, IRTs remain your best information source on the status of your trial.