Temperature Deviation and IRT

IRT Essentials

The ability to track the temperature excursions of an investigational product has taken on an increasing importance in clinical trials. Temp tales and similar devices are used to record the drug’s environmental exposure from the time it is sealed into a shipping container at the warehouse to the time it is unpacked at a clinical site. The electronically recorded temperature history is available for review by project teams and site personnel on demand.

A robust IRT (IVR/IWR) must be able to take into consideration the real-life, logistical issues associated with the issue of temperature deviation, whether ambient, refrigerated, or frozen.

Intuitive Subject Management

Case Studies, IRT Essentials

The surest way for a clinical trial data collection system to be rewarded by users with accolades like ‘intuitive and user friendly’ is for the system to be flexible-by-design — that is, to enable users to modify, by design, standard data views to include project-specific data points whenever the user logs in. This juggling act – standard-yet-flexible – is one of the first criterion one should apply when assessing a new system, whether it’s an EDC, CTMS, ePRO or IRT platform under consideration.
Using the Veracity Logic VLIRT® (IRT/IWR) platform as an example, a system’s architecture becomes ‘intuitive’ when built from the outset to encompass project specific additions to standard views without incurring additional time and costs for custom coding. Modular, configurable flexibility, selected by users at startup, is the key to success.

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)

Managing Drug With IRT

Case Studies, IRT Essentials

When selecting an IRT (IVR/IWR) system for your clinical trial, what features should it have to ensure you can adequately manage the critical but logistically complicated world of study drug?

Here’s a quick checklist of things to consider:

Ability to have ‘at-a-glance’ access to information relevant to study drug– for example, in a straightforward table view – without the need for complicated querying, and with the ability to deliver or withhold types of information based on user roles. An at-a-glance view should include:

Reconciliation-Free IRT

IRT Essentials

One of the questions most frequently asked by clients during demos of the Veracity Logic IRT (IVR/IWR) system is how best to handle the problem of having to reconcile data between a study’s IRT and EDC platforms.

The answer is twofold, but simple: First, move data between the two systems in only one direction. Second, set up your study so you don’t duplicate data in the two systems.

Electronic integration between the IRT and the EDC systems should be a one-way arrow – ideally, data should be ‘pushed’ from the IRT to the EDC. Not only is this cheaper than requiring a two-way transfer of data (i.e., also ‘pulling’ from the EDC into the IRT, which can double costs), but, depending on the EDC platform being used, it may also be technologically simpler, since EDC APIs to receive data may be more available than APIs to push data.

Four Ways to Reduce IRT Help Desk Calls

IRT Essentials

It’s essential to have a strong 24/7 Help Desk backing up your IRT vendor. But be sure the IRT system you’re choosing also has a sufficient array of ‘do it yourself’ options that will empower your study team to safely do system updates and save time and money by acting independently of the Help Desk.
Here are just four ways to reduce the need for vendor intervention:
1. Look for a system with a login screen that enables users who’ve forgotten (lost) their passwords to simply request a temporary credential to be sent to their email, without having to contact the Help Desk. This is the one item that most directly reduces the amount of Help Desk involvement!

Strata Versus Cohort: A Clarification

IRT Essentials

We’ve seen confusion in recent IRT (IVR/IWR) RFPs and study protocols in the use of ‘strata’ and ‘cohort’ when describing desired approaches to randomization. The words are often used in opposition – that is, one is often specified when it’s really the other that’s required.
This confusion in terminology can negatively impact the bidding timeframe, requiring back and forth clarification between vendor and sponsor, or worse yet, can wrongly inflate or deflate the final bid tally. Correcting after the fact also takes additional time. Better by far to specify the strata or cohort requirements correctly from the outset

How to Get a 2 Week IRT Rollout: Re-Inventing the URS

IRT Essentials

One of the things we try to do with our weekly hot topics is bring to the forefront the latest excitements, ideas, and controversies surrounding clinical trials and Interactive Response Technology (IRT/IVR/IWR).

Among the most hopeful initiatives touted in recent industry conferences is the goal of implementing a 2 week rollout for an IRT system, from Contract Approval to Release for Client Testing (UAT).

Smoke and mirrors? Pie in the sky?
Or is it actually feasible?

Actionable Intelligence from the IRT for CRAs

IRT Essentials

One of the hottest topics in the clinical trials industry today is the transition to Risk Based Monitoring (RBM) (see Guidance for Industry: Oversight of Clinical Investigations_ A Risk-Based Approach to Monitoring; and ICH E6 R2). RBM includes the addition of a new ‘centralized monitoring’ function which focuses on risk within and across sites and even across projects, data that is then bundled to inform CRA activities.

But the industry is in transition: the vast majority of clinical trials are still not integrated with RBM processes. Project Managers and CRAs must still rely on IRT and EDC platforms to accomplish the kind of ‘pre-RBM’ remote monitoring within a project that mitigates risk and helps determine where site visits are needed and the level/type of SDV activities required.