Protocol Deviations: We need authorization…quick!

Case Studies


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?


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.

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