Audit Trail and Access

Case Studies

Problem:

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?
Solution:

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?

Manual Shipment Requests: Help, I need more drug…!

Case Studies

Problem:

Your resupply algorithm for a particular Site has worked very well—until now. This month a generally low-enrolling site has inexplicably had a banner crop of new subjects. The site is running low on study drug. How do you get more drug to them fast?
Solution:

Veracity Logic’s flexible IRT system allows for unscheduled Manual Shipment Requests on demand. Authorized (unblinded) users can select the Manual Request option from the Shipments page and specify the precise number of each type of drug to be shipped. The IRT notifies the warehouse of the unscheduled order and warehouse personnel use the IRT to advise the site when their order has been sent. When the package arrives and site personnel mark the shipment ‘received’ via the system, the site inventory is updated within the IRT.

With Veracity Logic’s IRT, a project can have both Automatic and Manual Shipment Request capabilities available at a site level for whatever situation might arise.

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Need to shorten startup time without sacrificing project quality?

Case Studies

Problem:

Your study has a hard startup timeline but there have been an array of delays and modifications on the science side of things. You not only need to make up time, you need to make some changes to the specifications for your vendors, including your IRT system which is already in validation…and you need to do it all without killing your timeline or sacrificing quality. What to do?
Solution:

We know clinical trials…change is a common phenomenon! That’s why Veracity Logic’s IRT was designed to provide maximum flexibility for just such situations. The VLIRT® system was built with an emphasis on two key strategies:

Validated CORE technology
Configurable project system modifications

Our validated CORE informs risk assessment strategies to enable focused, efficient testing and a high quality product in a timeline-friendly fashion.

Our base of easily modified, quickly accessed, protocol-specific setup configurations keeps the need for custom coding to a minimum in the development and change management of all project systems.

Want more to know more about how VLIRT can make your life easier?

Forced Randomization …

Case Studies

Uh oh, we don’t have that drug type on the shelf…!
Problem:

Clinical site A has been slow but steady enrolling subjects for your study, and the IRT resupply schedule has been working just fine, provisioning the site with just the right amounts of the two types of study drug used in the study. But an unexpected bolus of three eligible subjects has enabled the site to exceed its usual goals. Unfortunately, the randomization schedule has just assigned three kits of the same treatment group to the new subjects. Problem is, site A only has two kits of that group left in its inventory! You don’t want to lose the third subject. What to do?!
Solution:

Veracity Logic’s IRT accommodates a variety of randomization schemas including “Forced Randomization”. In the Forced Randomization scenario, the inventory management module of the IRT ‘knows’ that site A is one kit short on the assigned treatment group. The system automatically skips ahead in the randomization schedule to the first available kit in a treatment group that is currently available in site A’s inventory. It then assigns that kit/treatment group to the subject. This ‘forcing’ of assignment is balanced by the system in subsequent randomizations in which the ‘skipped’ kit/treatment group is assigned at the next study opportunity.

A special notification sent to specified users documenting when a Forced Randomization assignment has occurred.

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

Summary Rollup Reports…

Case Studies

Problem:

Your drug supply depots are using up study drug faster than expected. You need to track down the problem. For one thing, you want to take a quick look at Subject Activities and see how many instances of unscheduled resupply of study drug have occurred in your study thus far, at all clinical sites globally, and, in particular, at Canadian sites, where the biggest problem seems to lie. How do you quickly get the information you need from your IRT?
Solution:

Veracity Logic’s IRT solves this problem with on-screen Activity Rollup function. A toggle on the Activities page brings up a summary report filterable by Country, Site, or Activity. Activity totals are provided at the Site, Country, and Study level (as defined for your project). The same summary data is presented for all other activities, including scheduled visits and unscheduled activities (such as Screen Failures, Early Withdrawals, and Unblinding).

Subject Rollup functionality, accessible by a toggle click on the Subjects page, is also a part of Veracity Logic’s standard offering. The Subject Rollup report provides at a glance the record of all scheduled subject visits that have occurred (and their dates) within and across subjects. This report is filterable by Subject Status, Site, and Country,

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

Reaching the Help Desk…

Case Studies

Problem:

Users of your IRT are having trouble remembering how to reach the Help Desk for system and project issues. Phone numbers and email addresses are provided in various documents, but somehow your study’s site users, project managers, and site monitors –globally!–don’t seem to be able to find them when they need them, or they waste valuable time looking. How can your IRT provider ease the pain?
Solution:

Veracity Logic’s IRT provides the Help Desk email address on the system login screen and again on a Help page within the project system, easily accessible from the Main Menu. Help Desk phone numbers for each Country are listed on the Help page as well. Users literally have help at their fingertips…just click the direct email link, or pick up the phone for more urgent issues requiring immediate resolution. If your study has an IVR (phone) component as well as a web interface, users can instantly reach the Help Desk by simply hitting the star key from anywhere in the call system. At VL, we figure the point of a Help Desk is to help!

Want to know more about the powerful standard offerings of Veracity Logic’s IRT platform? Choose Contact Us from the menu above for a demo!

Real-time Integration between IWR (web) and IVR (phone)…

Case Studies

Problem:

Your global trial includes 32 clinical sites in 12 countries and all but two have reliable access to the internet and your web-based IRT system. In the other two locations, internet connectivity comes and goes like a bad dream … with entirely too much down time for the sponsor’s comfort. An IVR (phone) option is added to the IRT, meaning that users at a site, at any given time may be using either the IWR (web) or IVR (phone) platform or both … sometimes attempting to modify the same subject record. How will order be kept?
Solution:

Veracity Logic’s IRT is designed to provide instant integration between its web and phone systems when circumstances call for IVR (phone) capability. If two persons attempt to modify the same data at the same time, only the first to save their change is allowed to proceed. The other is sent an instant on-screen message (or voice message) that the data has already been modified by another user, and the new data becomes available on the phone (if entered on the web) and on the web (if entered on the phone) as soon as the user returns to the menu. The IRT’s audit trail captures the data updates made via IWR (web) or IVR (phone).

Want more details about IVR interfaces? Choose Contact Us from the menu above.

Customizing Subject Unblinding …

Case Studies

Problem:

Protocol complexities often call for a customized approach to unblinding subjects in your clinical trial. First, authorized users need to receive an on-screen message with a very specific set of instructions when they begin to unblind a subject. Second, they need to be presented with a Yes/No option to confirm that the Site Monitor or Sponsor has been alerted. Third, the user needs to request and receive an immediate authorization code from a 24-hour Medical Monitor. That code must be entered before the unblinding can be completed. And of all of this must be accomplished quickly and efficiently.

Your current IRT’s standard system allows none of these options, and the study startup clock is ticking! What to do?
Solution:

Veracity Logic’s IRT platform is designed to maximize configurability and minimize complex coding requirements for a variety of custom setups such as the ones described above. These custom unblinding modifications can be accomplished with no additional impact on project development timelines and no loss of efficiency, saving precious time, when an emergency unblind needs to occur during 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. The fact that an unblinding has occurred can be easily tracked by Biostatisticians. In addition, for each study, clients can specify the list of users who will receive notification of each unblinding occurrence. The content of that notification is also readily configurable for study needs.

Product Recall

Case Studies

Houston, we have a problem…

These are the words no one wants to hear! Your clinical supplies vendor has called to tell you there is a problem with one of your drug batches. You need to locate and recall all kits in the batch for destruction.

– Where are the kits with the bad drug?
– Are there any already shipped to clinical sites?
– Any, heaven forbid, assigned to subjects?