Using Veracity Logic IRT’s Help Page…

Case Studies

Help, how do I get new documentation to the users?!
Problem:

Mid-study issues make it clear to your Project Manager that sites need new instructions to improve and clarify certain aspects of study conduct. The Project Manager puts together a User Guide, in six languages, for all study sites. The question now is how best to provide it to the clinical sites to insure it will be readily available for easy use.
Solution:

Veracity Logic’s IRT solves this problem by allowing authorized users to upload on-screen User Documentation as a standard feature of the system. The control is in your hands … users can easily add documents to the system via a simple ‘Upload Document’ button on the Help page off the Main Menu. Documents uploaded can relate to any aspect of your clinical trial –not just user manuals but process updates, new guidelines, even simply to disseminate interesting news. Outdated material is easily removed or replaced, making it easy to keep information current as things change throughout the study.

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

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?

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.

Protocol Deviations: We need authorization…quick!

Case Studies

Problem:

The study has been suffering from slow enrollment. An excellent candidate, medically speaking, walks into Site 101 but there’s one problem: The minimum enrollment age for the clinical trial is 18. The age of the new potential candidate is 17 years, eight months. The Study Coordinator at the site not only needs a quick decision, but one that protects the integrity of the protocol at the same time. What to do?
Solution:

Veracity Logic’s IRT system provides Authorization Codes for just such occasions. Site users contact designated personnel, such as the primary medical monitor, to obtain a quick field decision from the sponsor for whether the protocol deviation is advisable for the study. Authorization codes are held within the IRT system; available codes are easily accessed by the designated decision makers. A code documenting permission to register the subject is provided to the site user for entry into the IRT database. The fact that a protocol deviation has occurred, and the vital specifics of that deviation, can be easily tracked by the biostatisticians using Veracity Logic’s VLIRT® IRT.

Authorization codes can also be used to manage and document authorized unblinding of subject treatment data, wherever there is an intersection between the need for a speedy decision and the need for care and protection of protocol integrity.

This is just one of the many ways Veracity Logic’s IRT meets real-life scenarios with real-life solutions.

Reporting Problems with Kits…

Case Studies

Help, the delivery van ran over the study drug …!
Problem:

Despite the best laid plans, whatever can happen, does happen when a clinical trial is in the field. Examples:

Kit 690, the study drug unit about to be assigned to Subject A, was damaged in transit and can’t be assigned.
Subject B’s wife, trying to be helpful, stuck an ambient study drug into the fridge to keep it cool.
Site 101 has a record of Kit 702 having been received but Site personnel can’t find it on the shelf.
And the kit that was supposed to go to Subject C was distributed to Subject D by mistake! What to do?

Solution:

With Veracity Logic’s IRT managing your study drug distribution these unexpected events are easily dealt with and documented. Users select Report Problem from the Task Menu of the selected kit and with a single click record the details of Damaged, Missing, Temperature Deviation, or Misadministered kit. The Inventory page automatically reflects changes in kit status. Flexible functionality allows kit statuses to be modified yet again when problems are resolved, such as, when a missing kit is found or a temperature deviation is determined to be within acceptable parameters. The inventory-control functionality of Veracity Logic’s IRT system ensures you will always know the current status of each site’s inventory and the whereabouts of each individual kit in the study.

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

Returned Kits: I need to count capsules but my IRT doesn’t allow it…

Case Studies

Problem:

Your study’s protocol calls for the return of unused study drug to the clinical site at each visit, when new drug is distributed. This drug accountability needs to be documented not merely at the container level, which is the only way your current IRT allows, but at the capsule level as well. You need a quick and efficient way for each clinical site to document these returns throughout the study. How to do it?
Solution:

With Veracity Logic’s IRT, drug accountability is easily managed. Users chose Return Kit from the Task Menu of the selected kit; the system prompts the user to record the counts of the units Used and Returned. The system then determines if there are any units ‘unaccounted for’ in the kit. Standard functionality guides the process with edit checks to make sure the counts entered are consistent with the amount of drug originally dispensed. The use of the IRT to document drug returns ensures standardization of the drug accountability process across sites. And with Veracity Logic’s capability for easy system configuration, the modification of return functionality to suit your protocol needs is achieved with limited impact on timelines.

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

Blinded Inventory View

Case Studies

Problem:

A variety of critical personnel involved in a clinical trial, including Sponsors, CROs, and Clinical Suppliers, need to keep track of the daily inventory of study drug and ancillary product available at each clinical site in the study. But the standard IRT inventory record includes data that unblinds. You need a fast way to provide site inventory status to those who need information, without a loss of study integrity. How to solve the dilemma?
Solution:

Veracity Logic’s IRT has been developed over ten years of experience with issues exactly like this one in mind. Our system can readily provide both a blinded and an unblinded inventory view of the Inventory page of your project. You specify the users who will have access to each type of inventory view. Unblinded users will see the number of kits of each treatment type available at each site. Blinded users will see a ‘rollup’ report of the total counts of all kits (including both study drug and ancillary kits) available at each site. Administrative (unblinded) users will be able to toggle between the two views.

This is just one more of the many ways Veracity Logic’s IRT provides the power and flexibility you need to meet real-life scenarios with real-life solutions.