Accessing Event Notifications

Case Studies

The Challenge:

For a study lasting several years, it’s common to have turnover of study personnel. When this happens, new users need access to the notifications sent by the system prior to their arrival. Typically, new users have to ask for printouts of specific prior notifications, or the Help Desk is asked to send copies of all the past notifications generated for the site. How to streamline the process?

The Solution:

The Veracity Logic development team revised the Messages functionality of the IRT CORE system so that new users are, by default, able to view ALL of the notifications generated since the beginning of the project and appropriate to their assigned user role and site(s). Users can also choose to re-send prior notifications on demand.

Requesting Shipments …

Case Studies

Shipments, manual or automated, have it your way…
Problem:

So it’s time to decide what types of shipment requests you’ll use in your clinical trial. There will be crunch times when Manual Requests are essential; other times when system-generated Automatic Requests are optimal (i.e., generating a shipment when a site’s inventory reaches a pre-set level). For some studies, a Predictive approach (modifying resupply based on multiple variables) is desirable to prevent drug wastage and to keep busy sites from running out. And if these decisions weren’t hard enough, sites for which you wish to use the Predictive model vary in key components of the resupply algorithm, for example, the number of days it takes a shipment to arrive from the warehouse. What to do?
Solution:

Veracity Logic’s IRT is designed to provide maximum flexibility in the options available for shipping study drug.

Just as no two patients are alike, so are no two sites alike—therefore the VLIRT® system allows variation at the site level. For example, sites can vary in:

Whether or not Manual Requests are used
Whether or not Automatic resupply is used
Whether or not Predictive resupply is used
Alert levels for Automatic resupply
The values of predictive variables used to calculate resupply on a ‘need’ basis
The amount of resupply applied to Predictive models

VLIRT® also makes it easy to modify a site’s shipping preferences during the trial. And even sites receiving automatic shipments are given the additional ability to generate manual requests on demand whenever the need arises.

Want more details?

Acronym for This, Acronym for That

Newsletter Archive

Question: What is RTSM?

The recent CBI IRT Conference in Philadelphia made clear that a new acronym — “RTSM”– is coming into popular use to describe IRT systems. What is RTSM? And do we really need another acronym?
Response:

Our industry started using the term “Interactive Voice Response Systems (IVRS)” in the early 90’s to describe the typical phone-based systems used to capture IRT data for clinical trials. As use of web systems expanded, the term “Interactive Web Response Systems (IWRS)” sprung into being. To facilitate references to the two systems, vendors began using “IVRS/IWRS” to describe their product. Inevitably, the term “IxRS” came into use–an acronym which is now trademarked and used by only that one company.
IRT Widely Used

Finally, the term “Interactive Response Technology (IRT)” leapt in to fill the gap, and is now the one most commonly used to refer to the technology for managing subjects and clinical trial materials during a study. Or at least it was, until …

The question was asked, why use a term like IRT, which describes the technology but not its function in the clinical trials industry? After all, IRT systems are used widely in other industries, for other functions – for example, we interact with our bank accounts via the web or phone or mobile devices.
Randomization Trial Supply Management

“RTSM” stands for “Randomization and Trial Supply Management”. This reflects two of the major functions of a clinical trials IRT — randomizing subjects, and managing drug supply. This, at least, is a good thing. The downside of the new acronym is that it doesn’t go far enough — it labels us too narrowly and fails to highlight many important key functions.

Maybe we should come up with a new acronym that reflects the full subject management services that IRTs provide. How about “Subject Management And Randomization with Trial Supply or “SMARTS?” Okay, enough already.
Veracity Logic’s Validated Technology

Whichever acronym you choose: IVRS, IWRS, IRT, or RTMS — or even SMARTS! (we’re really only kidding about this one), Veracity Logic provides the validated technology for screening and randomizing subjects, recording subject activities, and managing the drug supply for your study.

Handling Data Corrections…

Case Studies

Problem:

There are many options for processing manual data changes in an IRT system. Some vendors make all data changes for the clinical site users. Others have electronic systems where users can request and approve changes, while still others require ‘wet’ signatures. What’s the best option for achieving the two key goals of change control, i.e., documenting user approval while streamlining the process so it doesn’t take days to make a change?
Solution:

At Veracity Logic, we put our emphasis on enabling and training authorized end-users to handle most manual data corrections themselves, just as they do in their EDC systems. The range of edit permissions varies based on the needs of each project.

We’ve found that most users not only don’t mind having the power to make many of the data corrections within the IRT, they actually prefer it to having to generate paper requests and factor in vendor response time (not to mention the increased cost of PM and Help Desk involvement).

For changes that technologically require vendor action, we make the change for them using a documented paper/signature trail. We don’t require the document contain a ‘wet’ signature, a faxed or PDF’d copy is sufficient.

Regardless of the method used, a proper audit trail must be kept whenever changes are made to clinical data by authorized users and it needs to include a justification/reason for the change. That said, when such capabilities (proper authorization, a full audit trail and requirement for recording the reason for a data change) are included in an IRT system, tied with the ability to ‘attach’ notes to records within the database, the additional time/effort of a laborious paper-based process is unnecessary.

Tracking Temperature Deviations…

Case Studies

Yikes, someone left the package out in the heat!
Problem:

Your drug must remain within a set temperature range at all times. How are you going to ensure drug that experiences a temperature deviation is not distributed to subjects?

Your packaging and transport vendor(s) will record temperature deviations that occur between the manufacturer and the clinical site. Great! But what about the IRT’s inventory tracking? How does it know to hold that drug? And what to do with it next?
Solution:

When the site receives the shipment, they will have to answer the question, “Did the shipment experience a temperature excursion?” before being able to proceed. If yes, Veracity Logic’s IRT gives you the power to make important decisions:

You can specify which types of temperature excursions occurred – i.e., ambient, refrigerated, frozen, or all three.
You can specify whether some or all of the kits in the shipment were affected.
After reviewing the temperature excursion details, you can decide to reinstate a kit or a shipment and make it once again ‘available’ for assignment to subjects.
Conversely, you can quarantine the kit or shipment after reviewing the deviation details. Quarantined kits will remain unavailable for assignment and will automatically be replaced in inventory in the next shipment.
You can designate kits and shipments for destruction or for return to the warehouse.

In other words, Veracity Logic’s IRT gives you the flexibility to meet real-life scenarios with real-life solutions.

Drug Hiatus…

Case Studies

Hey, I need a break from the dosing regimen…!
Problem:

Your study has a fairly complex drug titration pattern. In addition to multiple pre-planned titrations, subjects in your clinical trial can go up or down one dose level in the maintenance phase, based on medical assessment. If the subject has an unusual medical event intervene in the ‘dose escalation’ phase – for example, a hospital stay for an unrelated issue – the subject may either need to be discontinued from the trial or somehow be permitted a ‘drug vacation’ after which the system will permit return to a previous dose/visit level or movement to a new level. How to do this with an IRT?
Solution:

Other IRT systems may not allow this flexibility. But Veracity Logic’s IRT includes a ‘drug hiatus’ functionality which permits a subject to maintain their regular visit schedule but take a break from drug assignment. At the end of the hiatus period, its length set by protocol or flexibly determined by medical assessment, subjects return to drug assignment, either at the previous dose level or at a new level.