Instrumentation of a paper diary to create an objective record of events
First Claim
1. An instrumented paper diary for recording data, comprising:
- at least one paper form for recording data; and
electronic instrumentation for generating an electronic record containing information regarding use of the diary.
3 Assignments
0 Petitions
Accused Products
Abstract
A device for monitoring subject compliance comprising an instrumented paper diary for subjects to record clinical trial data. The instrumented paper diary creates an objective record of the use of the diary to verify subject entries, allowing researchers and clinicians to systematically track the use of the diary in the field. Subjects record clinical trial data in a paper diary. Electronic instrumentation connected to the paper diary allows use of the diary (e.g. when it was opened and closed) to be unobtrusively tracked, recorded and evaluated against how research protocols dictate the diary to be used. The instrumented paper diary creates an objective electronic record of when the diary was being opened/closed or written upon, allowing researchers to confirm whether the date and time written on diary entries correspond to reported diary use. The handwritten entries in the diary can be checked against the electronic record of when the diary was in use to confirm that the person completed the diary entry when they recorded that they completed it. A variety of different types of instrumentation can be used to collect a variety of data regarding the diary use; including whether it is opened, closed, left open for a long period of time, or being carried with people throughout the day.
22 Citations
51 Claims
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1. An instrumented paper diary for recording data, comprising:
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at least one paper form for recording data; and
electronic instrumentation for generating an electronic record containing information regarding use of the diary. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21)
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22. A subject compliance monitoring system, comprising:
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an instrumented paper diary including paper forms allowing a subject to enter data and electronic instrumentation for generating an electronic record of diary use; and
an electronic device for displaying and viewing the electronic record. - View Dependent Claims (23, 24, 25, 27, 28, 29, 30, 31, 32)
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26. A device for monitoring subject compliance in a clinical trial, comprising:
an electronic device for use with a paper diary, wherein the electronic device generates an electronic record tracking clinical trial data.
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33. A method of monitoring subject compliance, comprising:
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detecting an event related to data entry in a paper diary for recording data; and
capturing and storing a characteristic of the event to generate an electronic record of said data entry. - View Dependent Claims (34, 35, 36, 37, 38, 39, 40, 41)
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42. A method of confirming data obtained in a clinical trial, comprising:
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generating an electronic record containing information regarding use of a paper diary for recording clinical trial data; and
comparing said electronic record with written clinical trial data in the paper diary. - View Dependent Claims (43, 44, 45, 46, 48, 49, 50)
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47. A method of monitoring subject compliance in a clinical trial, comprising:
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providing a subject with an instrumented paper diary for recording clinical trial data; and
tracking the subject'"'"'s use of the instrumented paper diary.
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51. A method of making an instrumented paper diary, comprising:
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providing a paper diary including paper forms for a user to record data;
providing electronic instrumentation for tracking use of the diary; and
connecting said electronic instrumentation to the paper diary to record when the diary is in use.
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Specification