How to Test an IRT: A Primer for Users, Part II

IRT Essentials

You’ve worked through the user requirements for your clinical project and how it will be implemented by your Interactive Response Technology (IRT/IWR/IVR) vendor. Your vendor has built the system and completed their verification testing to confirm it meets user specifications (see How to Test an IRT, Part I). Presumably your team has also had a chance to join the vendor for an informal walk-through of the system to confirm, in global terms, that it correctly supports your project.

Now it’s time for you to complete your User Acceptance Testing (UAT) to validate the project IRT.

How to Test an IRT: A Primer for Users, Part I

IRT Essentials

Regulatory requirements and plain old common sense make the documented testing and validation of the electronic systems used in clinical trials of critical importance to the success of any clinical study. To put it bluntly, approval authorities around the world will reject clinical data collected by what regulators deem to be substandard means (see, e.g., 21CFRPart11, EU Annex 11, etc)
Veracity Logic is an exclusive IRT (IWR/IVR) vendor, so let’s get into the nitty-gritty of what this means for IRT systems.

Checklists can save you — stress!

IRT Essentials

Everyone makes mistakes – it’s part of being human. We’re not automatons who simply complete tasks day in and day out. If only life were that simple. It seems there are always small “tweaks” to any process involving information management and processing. The question is, how do we minimize errors and remove stress from our lives?

One answer, simple though it seems, is to create checklists — quick, focused lists of reminders. Most of us already have Standard Operating Procedures (SOPs) for each of our processes. Yet few staff find it convenient to re-review an SOP during the execution of a task — not only have they already been trained in that task, but many SOPs are complex documents with more (or less!) information than they need.

Quality Through The Ages

IRT Essentials

Imagine it’s 325 B.C.E and you’re at Aristotle’s school, the Lyceum, in Athens. A builder has come to ask Aristotle’s advice. He explains that his workers have not done well with recent jobs and the customers are finding other builders. He has corrected the issues he’s found in the work but this is costing him his profits for the job when work must be redone. He asks, “can you help me?”

Aristotle ponders for a moment, then says, “Quality is not an act, it is a habit.” And so, we have history’s first formal statement about quality: Quality is not a special, ‘extra’ activity, but a way of intrinsically performing one’s work.

Pharma Quality at Biotech Pricing

IRT Essentials

Earlier this year we attended a conference at which one presenter put up a slide titled, “Pharma Quality at Biotech Prices.” We recall thinking what an odd approach to quality this phrase represents. It could be seen to imply that quality is based on the size of a company and on the amounts spent – i.e., that more is more where quality is concerned. But is this true?

How to Think About Document Retention

IRT Essentials

Perhaps one of the most inconsistently fulfilled industry regulations in the world of clinical trials is the process for document management, including policies for document retention. Companies vary widely in their approach to these important aspects of drug development record-keeping despite the longstanding industry axiom that says “If it isn’t documented, it didn’t happen!”

David Goldston, Managing Director of Veracity Logic, an IRT (IWR/IVR) provider that has been successfully deploying IRT systems globally for more than a decade, has a Master’s degree in Information Science and has spent much of his career, first in large CROs, then as IRT co-owner, establishing Standard Operating Procedures (SOPs) for compliant quality control of clinical trial documentation.

Why Visual Verification?

Case Studies

The Problem: On the one hand we’ve got statistics. On the other hand, we’ve got human lives. Because of the latter, our hearts tend to have zero tolerance for errors in clinical trial data. How do we find the right level of risk and quality control (QC)?

Let’s tempt the wrath of risk assessors everywhere and look at the issue. What’s the real purpose of QC? To be sure, it is NOT to achieve perfection. On that most of us can wholeheartedly agree, including the FDA.

The question is how to decide how much and which types of QC will help ensure the acceptable error margins we’ve set for ourselves.

That’s a whole other kettle of fish.

The Solution: What we strive to produce is a quality management system that works as a whole. Over time, we add and subtract QC tasks until the right balance emerges—one that satisfies both the risk assessment model and the passion for correct data.

At Veracity Logic, one of the steps in our total QC package is a little bit of bother known as “visual verify”. We’ve reached down into the data management archives, pulled it out, dusted it off, and propped it up on the mantel, remembering a time when it was axiomatic that any single-entry act in the double entry world of quality control had to be independently reviewed. One can almost hear the wooden wagon wheels creaking….

Every data change (DCR) and configuration change (CCR) we’re asked to make in an active IRT project system is executed by a qualified project team member and then subjected to an independent visual confirmation by another qualified member of the team. Successful verification is signed off by the reviewer and becomes part of the project record. Only then is the DCR/CCR regarded as complete.

One almost wants to hum the theme song from ‘Somewhere In Time’…

Audit Trail and Access

Case Studies


Tom Smith, a Study Coordinator at Site A in your clinical study, retired from the project three months ago. Due to a communication snafu, your clinical staff forgot to remove Tom’s name from the roster of active system users of the project’s IRT system. Two months later, your company’s QA group discovers this fact during their bi-annual production audit of the IRT vendor. From a regulatory perspective (not that they don’t trust Tom, honest!), they have to be concerned about the potential for unauthorized data changes…and about the fact that someone no longer assigned to the project could continue to view production data. How to quickly put all issues and concerns to bed?

Veracity Logic’s IRT provides access to its robust audit trail in two ways: interactively, at the level of each item, and via a ‘global’ audit trail which maintains the cumulative record of all data changes that have occurred on a given project. The VLIRT® audit trail captures the old and new data, timestamp and date of change, user making the change, and a justification (required) for the change. A quick query of the global audit trail will reveal any data changes made by Tom Smith subsequent to his date of departure. The system also captures the last login date/time for Tom. QA can rest easy when it sees that Tom last logged into the system prior to his departure date.

Want to hear about other ways Veracity Logic’s IRT can help solve project problems?

Can Your IRT System Help You Manage Protocol Deviations?

Newsletter Archive

Your 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: Authorization Codes
Veracity Logic’s IRT system provides Authorization Codes for just such occasions. Site users contact designated personnel to obtain a quick field decision as to 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 for entry into the IRT database. And all of this can be done within minutes! The fact that a protocol deviation has occurred, and the vital specifics of that deviation, can be easily tracked by Biostatisticians using Veracity Logic’s IRT.

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

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