Method and Apparatus for Verification of Clinical Trial Adherence
First Claim
1. A method of confirming administration of medication in a clinical trial, comprising the steps of:
- identifying a particular medication prescription regimen in accordance with the clinical trial;
determining one or more procedures for administering such prescription regimen including ingestion of the medication in accordance with the clinical trial;
identifying one or more video activity sequences associated with such procedures;
capturing video activity sequences of actual administration including ingestion of such prescription regimen by a video capture device;
storing the captured video activity sequences to a non-transitory computer readable storage medium;
comparing the stored video activity sequences to the identified video activity sequences by a computer processor to determine differences therebetween; and
providing a notice if differences are determined, thereby automatically determining by the computer processor that confirmation of proper medication administration including ingestion has failed.
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Accused Products
Abstract
A system and method of confirming administration of medication in a clinical trial is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen in accordance with the clinical trial, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.
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Citations
21 Claims
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1. A method of confirming administration of medication in a clinical trial, comprising the steps of:
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identifying a particular medication prescription regimen in accordance with the clinical trial; determining one or more procedures for administering such prescription regimen including ingestion of the medication in accordance with the clinical trial; identifying one or more video activity sequences associated with such procedures; capturing video activity sequences of actual administration including ingestion of such prescription regimen by a video capture device; storing the captured video activity sequences to a non-transitory computer readable storage medium; comparing the stored video activity sequences to the identified video activity sequences by a computer processor to determine differences therebetween; and providing a notice if differences are determined, thereby automatically determining by the computer processor that confirmation of proper medication administration including ingestion has failed. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A system for confirming administration of medication in a clinical trial, comprising:
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an authentication apparatus for authenticating a clinical trial manager; an input device for receiving information identifying a particular medication prescription regimen from the authenticated clinical trial manager; a database comprising prescription administration information for the medication subject to the clinical trial, a storage device for storing prescription administration selected from the database and being associated with the identified medication prescription subject to the clinical trial, a set of instructions in accordance with which the prescription regimen is to be administered including ingestion of the medication, and one or more activity sequences associated with such instructions; a video capture device for capturing video activity sequences of actual administration of such prescription regimen including ingestion of the medication over a plurality of administrations of the prescription regimen; a processor for comparing the captured video activity sequences to the identified video activity sequences including ingestion of the medication to determine differences therebetween, thereby automatically determining by the processor that confirmation of proper medication administration has failed; and an output device for providing an immediate notice if differences are determined in the comparing step by the processor that may place a patient receiving the prescription regimen in danger; and
for providing a notice if differences are determined in the comparing step that may improve future administration of the prescription regimen in the clinical trial. - View Dependent Claims (12, 13)
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14. A method of confirming administration of medication in a clinical trial, comprising the steps of:
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authenticating a prescribing clinical trial manager; receiving information identifying a particular medication prescription regimen from the authenticated clinical trial manager; determining one or more procedures for administering such prescription regimen including ingestion of the medication from one or more databases including prescription regimen information in accordance with prescription information provided by the authenticated clinical trial manager; modifying the procedures, if necessary, by the authenticated clinical trial manager; providing a set of instructions including ingestion of the medication in accordance with which the prescription regimen is to be administered; identifying one or more visual indicia for determining confirmation of prescription administration including ingestion of the medication associated with such instructions; capturing appropriate visual indicia of actual administration including ingestion of such prescription regimen over a plurality of administrations of the prescription regimen by a video capture device; storing the captured visual indicia to a non-transitory computer readable storage medium; comparing by a computer processor the captured indicia for determining confirmation of prescription administration including medication ingestion to the identified indicia for determining confirmation of prescription administration including medication ingestion to determine differences therebetween; providing an immediate notice if differences are determined in the comparing step by the computer processor that may place a patient receiving the prescription regimen in danger; and providing a notice if differences are determined in the comparing step by the computer processor that may improve future administration of the prescription regimen in the clinical trial. - View Dependent Claims (15, 16, 17, 18, 19, 20, 21)
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Specification