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: