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?

Join VL at the CBI IRT 2016 Conference in Philadelphia…

Events

Please join David Goldston, VL Managing Director, and Toni Goodyear, VL Associate Director, at this year’s CBI IRT 2016 Conference (October 25 – 26) at the Hilton Penn’s Landing in Philadelphia, PA. We’ll be haunting the sessions and looking for opportunities to share information about our favorite topic, IRT solutions. Let us know what your biggest issue is with the current crop of IRT solutions, we’ll help you find ways to resolve them.

Join Veracity Logic at the 2016 OmniComm Innovation Forum…

Events

Please join David Goldston, VL Managing Director, and Toni Goodyear, VL Associate Director, at this year’s OmniComm Innovations Forum (October 20 – 21) at the Miami Beach Hyatt in Fort Lauderdale, FL. Veracity Logic is a technology partner with OmniComm, providing data integration between our flagship VLIRT® system and OmniComm’s TrialMaster and TrialOne EDC systems.