# US 12,002,554 B2 · Management and tracking solution for specific patient consent attributes and permissions

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- Number: US 12,002,554 B2
- Document ID: US12002554B2
- Status: Granted
- Kind: B2
- Application number: 17/710,090
- Filed: 2022-03-31
- Published: 2022-07-14
- Granted: 2024-06-04
- Earliest claimed: 2019-02-20
- Assignees: IQVIA Inc.
- Applicants: IQVIA Inc.
- Inventors: Peter Hassett
- Web page: https://patentgrep.com/patent/US12002554B2

## CPC

- G16H 10/20: for electronic clinical trials or questionnaires
- G16H 40/20: for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
- G06F 40/174: Form filling; Merging
- G06F 40/197: Version control (for software G06F8/71)
- G06Q 10/10: Office automation; Time management
- G16H 10/40: for data related to laboratory analysis, e.g. patient specimen analysis
- G16H 10/60: for patient-specific data, e.g. for electronic patient records
- G06F 3/0482: Interaction with lists of selectable items, e.g. menus
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- G06F: ELECTRIC DIGITAL DATA PROCESSING (computer systems based on specific computational models G06N)
- G06Q: INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR

## Abstract

A method of managing consent using a computing device, the consent is given by a subject to one or more events in one or more studies, wherein the consent and the plurality of activities are changeable, the method including: authoring one or more first data forms describing the one or more events and one or more selections responsive to the one or more events; authoring, for each of the plurality of subjects, one or more second data forms including description of a plurality of preferences; forming, for a first of the plurality of subjects, an Informed Consent Forms document by combining the one or more first data forms of a first of the one or more studies and one or more second data forms for the first subject; and generating a manifest indicating the one or more events in the first study to which the first subject has granted consent.

## Claims

### Claim 1

A computing-device implemented method, comprising:
presenting user-selectable attributes and user-selectable data fields to an administrator;
constructing an informed consent form (ICF) for participants of a medical study based on a first set of selections of the administrator;
receiving consent to the ICF from the participants of the medical study, wherein the ICF includes attributes of the medical study;
generating a record for each participant, wherein each record includes an identifier of the participant, the attributes of the ICF, and a version identifier that is unique to the ICF;
constructing a modified ICF based on a second set of selections of the administrator;
receiving consent to the modified ICF from one or more of the participants, wherein the modified ICF includes a modified attribute;
updating the records of the one or more participants for whom consent to the modified ICF is received to reflect the modified attribute and a version identifier that is unique to the modified ICF; and
generating a report based on the records of the participants from the medical study, wherein the report includes the participant identifiers and attributes for which the respective participants have consented.

### Claim 2 (depends on 1)

The method of claim 1, wherein the report further includes:
consent statuses of the respective participants.

### Claim 3 (depends on 2)

The method of claim 2, wherein the consent statuses are based on the version identifiers of the ICFs to which the respective participants consented.

### Claim 4 (depends on 1)

The method of claim 1, further comprising:
constructing a second ICF for a second medical study based on a third set of selections of the administrator;
wherein the generating a report comprises generating the report based on records of participants of the medical study and participants of the second medical study.

### Claim 5 (depends on 1)

The method of claim 1, further comprising:
associating a scannable code with each of the participants; and
associating the scannable codes with biological samples of the respective participants.

### Claim 6 (depends on 1)

The method of claim 1, further comprising:
receiving a code from a code scanning device; and
retrieving the record of one of the participants based on the code.

### Claim 7 (depends on 1)

The method of claim 1, further comprising:
searching the records to identify participants who have not consented to the modified ICF;
searching the records to determine uses of biological specimens for which respective participants have consented; and/or
searching the records to identify biological specimens for which a desired use is permitted.

### Claim 8 (depends on 1)

The method of claim 1, wherein the attributes include attributes related to collection, use, and/or disposition of biological samples of the participants.

### Claim 9 (depends on 1)

The method of claim 1, wherein the ICF further includes data fields to capture personal information of the participants.

### Claim 10 (depends on 1)

The method of claim 1, wherein the attributes include a type of biological specimen of the medical study.

### Claim 11 (depends on 10)

The method of claim 10, wherein the attributes include at least one of a blood type, genome sequence, or sample of blood.

### Claim 12

A non-transitory computer readable media encoded with a computer program that comprises instructions to cause a processor to:
present user-selectable attributes and user-selectable data fields to an administrator;
construct an informed consent form (ICF) for participants of a medical study based on a first set of selections of the administrator;
receive consent to the ICF from the participants of the medical study, wherein the ICF includes attributes of the medical study;
generate a record for each participant, wherein each record includes an identifier of the participant, the attributes of the ICF, and a version identifier that is unique to the ICF;
construct a modified ICF based on a second set of selections of the administrator;
receive consent to the modified ICF from one or more of the participants, wherein the modified ICF includes a modified attribute;
update the records of the one or more participants for whom consent to the modified ICF is received to reflect the modified attribute and a version identifier that is unique to the modified ICF; and
generate a report based on the records of the participants from the medical study, wherein the report includes the participant identifiers and attributes for which the respective participants have consented.

### Claim 13 (depends on 12)

The non-transitory computer readable media of claim 12, wherein the report further includes:
consent statuses of the respective participants.

### Claim 14 (depends on 13)

The non-transitory computer readable media of claim 13, wherein the consent statuses are based on the version identifiers of the ICFs to which the respective participants consented.

### Claim 15 (depends on 12)

The non-transitory computer readable media of claim 12, further comprising instructions to cause the processor to:
construct a second ICF for a second medical study based on a third set of selections of the administrator; and
generate the report based on records of participants of the medical study and participants of the second medical study.

### Claim 16 (depends on 12)

The non-transitory computer readable media of claim 12, further comprising instructions to cause the processor to:
associate a scannable code with each of the participants; and
associate the scannable codes with biological samples of the respective participants.

### Claim 17 (depends on 12)

The non-transitory computer readable media of claim 12, further comprising instructions to cause the processor to:
receive a code from a code scanning device; and
retrieve the record of one of the participants based on the code.

### Claim 18 (depends on 12)

The non-transitory computer readable media of claim 12, further comprising instructions to cause the processor to:
search the records to identify participants who have not consented to the modified ICF;
search the records to determine uses of biological specimens for which respective participants have consented; and/or
search the records to identify biological specimens for which a desired use is permitted.

### Claim 19 (depends on 12)

The non-transitory computer readable media of claim 12, wherein the attributes include attributes related to collection, use, and/or disposition of biological samples of the participants.

### Claim 20 (depends on 12)

The non-transitory computer readable media of claim 12, wherein the ICF further includes data fields to capture personal information of the participants.