Methods and systems for recording verifiable documentation

Abstract

Systems and methods for collecting information, verifying authenticity of such information, processing, maintaining, and managing such information are described. The system can be a standalone unit or can comprise a combination of various units configured to function together.

1 .- 44 . (canceled) 
     
     
         45 . A method of executing agreements between parties involved in a protocol procedure, the method comprising:
 providing a system comprising an electronic device and/or a remote server, and a database library comprising a plurality of agreements or a plurality of parts of an agreement; the electronic device or the remote server being remotely connectable to the database library and further loaded with a software application and/or remotely accessing the software application on the remote server;   associating one or more identifying elements with one or more agreements, or with one or more parts of an agreement,   selecting, by the electronic device, the one or more agreements or the one or more parts of an agreement in the database library;   processing, by the electronic device, the one or more identifying elements of the selected one or more agreements or one or more parts of an agreement;   the electronic device or the remote server determining, by the software application, whether the processed one or more identifying elements are consistent with expected one or more identifying elements for the selected one or more agreements or the one or more parts of an agreement, such that when consistency between the processed one or more identifying elements and the expected one or more identifying elements is present, the electronic device or the remote server identify the one or more agreements or the one or more parts of an agreement as being an appropriate agreement or appropriate part of an agreement.   
     
     
         46 . The method according to  claim 45 , wherein the electronic device or the remote server allow the party to agree to contents, requirements, nature and/or terms of the agreement or part of an agreement on the electronic device if the electronic device or the remote server determine presence of said consistency. 
     
     
         47 . The method according to  claim 45 , wherein the appropriate agreement or appropriate part of an agreement is a most up-to-date agreement or part of an agreement. 
     
     
         48 . The method according to  claim 45 , wherein the one or more identifying elements include meta-data. 
     
     
         49 . The method according to  claim 45 , wherein the one or more identifying elements include version numbers. 
     
     
         50 . The method according to  claim 45 , wherein the plurality of the agreements are created by a plurality of creators, the plurality of the agreements being sold from a master library. 
     
     
         51 . The method according to  claim 50 , wherein the agreement is adapted to be downloaded from the master library or accessed remotely from the master library, such that the download or access allows an agreement creator to collect compensation for use of the agreement creator's agreement. 
     
     
         52 . The method according to  claim 45 , wherein the electronic device is adapted to access the database library by way of a wired or wireless connection. 
     
     
         53 . The method according to  claim 45 , wherein the one or more agreements or the one or more parts of an agreement are displayed on a display of the electronic device. 
     
     
         54 . The method according to  claim 45 , wherein the agreement is selected from the group consisting of: medical agreement, clinical agreement, financial agreement, business agreement, government agreement, contract, consent, waiver, and disclosure. 
     
     
         55 . The method according to  claim 45 , wherein the one or more parts of an agreement are selected from the group consisting of: text of the agreement; multiple language translations of the text of the agreements; associated videos, audio recordings, games, questions, answers, and other associated data concerning the one or more agreements. 
     
     
         56 . The method according to  claim 45 , wherein the one or more parts of an agreement are combined to make up one agreement. 
     
     
         57 . The method according to  claim 45 , wherein the one or more agreements and the one or more parts of an agreement are stored in the database library. 
     
     
         58 . The method according to  claim 45 , wherein the one or more agreements and the one or more parts of an agreement are amended and/or revised in the database library several times during a period of the protocol procedure. 
     
     
         59 . The method according to  claim 58 , wherein when consistency between processed one or more identifying elements and expected one or more identifying elements is not present, the electronic device or the remote server select a more up-to-date one or more agreements or a more up-to-date one or more parts of an agreement. 
     
     
         60 . The method according to  claim 45 , wherein the protocol procedure is selected from the group consisting of: consuming a pill, consuming a powder, consuming a liquid, injecting a medication, drawing blood, measuring body functions, measuring body temperature, measuring blood pressure, measuring glucose, answering medical questions, performing a physical examination; dispensing an investigational product, consuming an investigational study product, filling out a diary, scale, questionnaire; preparing food, consuming food, preparing a beverage, consuming a beverage, applying a cream, applying a gel, measuring weight, measuring height, measuring body size, performing an EKG, performing a stress test, collecting urine, collecting saliva, collecting stool, collecting semen, and drawing blood; answering medical questions; performing a physical examination; dispensing and/or taking an investigational study product; eating a specific study related food or beverage; measuring a body function such as temperature, blood pressure, and blood sugar; measuring an anthropomorphic measurement; collecting a specimen such as urine, saliva, stool, semen, or blood; determining, measuring, or diagnosing a patient condition or parameter; analytic laboratories, surgeries, pathology procedures, dermatology procedures, gastroenterology procedures, cardiology procedures, obstetrics procedures, gynecology procedures, oncology procedures, orthopedics procedures, pediatrics procedures, internal medicine procedures, sleep medicine procedures, rehabilitation procedures, radiology procedures, and/or urology procedures. 
     
     
         61 . A system for executing one or more agreements between parties involved in a protocol procedure, the system comprising:
 an electronic device loaded with a software application and/or remotely accessing the software application on a remote server;   a database library connected with the electronic device or with the remote server and including one or more agreements, or one or more parts of an agreement, wherein one or more identifying elements are associated with the one or more agreements, or with one or more parts of an agreement;   wherein the electronic device or the remote server are programmed to:   select one or more agreements or one or more parts of an agreement in the database library;   process the one or more identifying elements of the selected one or more agreements or one or more parts of an agreement; and   determine, by the software application, whether the processed one or more identifying elements are consistent with expected one or more identifying elements for the selected one or more agreements or one or more parts of an agreement, such that when consistency between the processed one or more identifying elements and the expected one or more identifying elements is present, the electronic device or the remote server identify the one or more agreements or the one or more parts of an agreement as being an appropriate agreement or appropriate part of an agreement.   
     
     
         62 . The system according to  claim 61 , wherein the system is programmed, upon determination of presence of said consistency, to document a process of the party consenting to the agreement by documenting that the party consents to the agreement, thus authenticating the party executing the agreement. 
     
     
         63 . The system according to  claim 61 , wherein the appropriate agreement or appropriate part of an agreement is the most up-to-date agreement or part of an agreement. 
     
     
         64 . The system according to  claim 61 , wherein the one or more identifying elements include meta-data. 
     
     
         65 . The system according to  claim 61 , wherein the one or more identifying elements include version numbers. 
     
     
         66 . The system according to  claim 61 , wherein the agreement is selected from the group consisting of: medical agreement, clinical agreement, financial agreement, business agreement, government agreement, contract, consent, waiver, and disclosure. 
     
     
         67 . The system according to  claim 61 , wherein the one or parts of an agreement are selected from the group consisting of: text of the agreement; multiple language translations of the text of the agreements; associated videos, audio recordings, games, questions, answers, and other associated data concerning the one or more agreements. 
     
     
         68 . The system according to  claim 61 , wherein the one or more agreements and the one or more parts of an agreement are amended and/or revised in the database library several times during a period of the protocol procedure, and wherein, when consistency between the processed one or more identifying elements and the expected one or more identifying elements is not present, the electronic device or the remote server is programmed to select a more up-to-date one or more agreements or a more up-to-date one or more parts of an agreement. 
     
     
         69 . A method of managing participation in one or more protocol procedures related to the care of a subject, the method comprising:
 providing a system comprising an electronic device loaded with a software application and/or remotely accessing the software application on a remote server, and a database library comprising protocol procedures data relating to underway activities performed by the subject, a clinical practitioner, or a professional involved in the protocol procedures; the electronic device and/or the remote server being remotely connectable to the database library; and by the electronic device:
 i) validating identity of the subject, clinical practitioner, or professional accessing the electronic device in order to perform an activity of one protocol procedure; and 
 ii) determining, by the software application, whether the identified subject, clinical practitioner, or the professional are already involved in one or more other activities related to one or more additional protocol procedures, and whether any of the one protocol procedure and the one or more additional protocol procedures allow the subject, clinical practitioner, or professional to participate in more than one protocol procedures. 
   
     
     
         70 . The method of  claim 69 , wherein if any of the one protocol procedures and the one or more additional protocol procedures do not allow the subject, clinical practitioner, or professional to participate in more than one protocol procedures, the device prohibits the subject clinical practitioner, or professional from participating in the one protocol procedure. 
     
     
         71 . The method of  claim 69 , wherein said validating identity of the subject, clinical practitioner, or professional includes video recording the subject, clinical practitioner, or professional accessing the electronic device. 
     
     
         72 . The system of  claim 71 , wherein the video recording is performed by a camera controlled by the software application. 
     
     
         73 . The method of  claim 69 , wherein validating identity of the subject, clinical practitioner, or professional comprises biometric identification. 
     
     
         74 . The method of  claim 73 , wherein the biometric identification is selected from the group consisting of: face recognition, fingerprints, retina scan, voiceprint, iris scan, typing biometrics, hand and finger geometry, signature verification, ear geometry, olfactory biometrics, and behavioral biometrics. 
     
     
         75 . The method of  claim 69 , wherein data about identity of the subject, clinical practitioner, or professional are stored in the database library. 
     
     
         76 . The method according to  claim 69 , wherein the protocol procedure is selected from the group consisting of: consuming a pill, consuming a powder, consuming a liquid, injecting a medication, drawing blood, measuring body functions, measuring body temperature, measuring blood pressure, measuring glucose, answering medical questions, performing a physical examination; dispensing an investigational product, consuming an investigational study product, filling out a diary, scale, questionnaire; preparing food, consuming food, preparing a beverage, consuming a beverage, applying a cream, applying a gel, measuring weight, measuring height, measuring body size, performing an EKG, performing a stress test, collecting urine, collecting saliva, collecting stool, collecting semen, and drawing blood; answering medical questions; performing a physical examination; dispensing and/or taking an investigational study product; eating a specific study related food or beverage; measuring a body function such as temperature, blood pressure, and blood sugar; measuring an anthropomorphic measurement; collecting a specimen such as urine, saliva, stool, semen, or blood; determining, measuring, or diagnosing a patient condition or parameter; analytic laboratories, surgeries, pathology procedures, dermatology procedures, gastroenterology procedures, cardiology procedures, obstetrics procedures, gynecology procedures, oncology procedures, orthopedics procedures, pediatrics procedures, internal medicine procedures, sleep medicine procedures, rehabilitation procedures, radiology procedures, and/or urology procedures. 
     
     
         77 . The method of  claim 69 , wherein validating identity of the subject, clinical practitioner, or professional is selected from the group consisting of: name, social security number, driver's license number, passport number, other government identification documents, address, date of birth, video of the subject, audio of a subject, still image of a subject, and biometric identification of a subject. 
     
     
         78 . A system for managing participation in one or more protocol procedures related to the care of a subject, the system comprising:
 an electronic device loaded with a software application and/or remotely accessing the software application on a remote server;   a database library connected with the electronic device or with the remote server and including protocol procedures data relating to underway activities performed by the subject, a clinical practitioner, or a professional involved in the protocol procedures;   wherein the electronic device or the remote server are programmed to:   validate identity of the subject, clinical practitioner, or professional accessing the electronic device in order to perform an activity of one protocol procedure; and   determine, by the software application, whether the identified subject, clinical practitioner, or the professional are already involved in one or more other activities related to one or more additional protocol procedures, and whether any of the one protocol procedure and the one or more additional protocol procedures allow the subject, clinical practitioner, or professional to participate in more than one protocol procedures.   
     
     
         79 . The system of  claim 78 , wherein if any of the one protocol procedure and the one or more additional protocol procedures do not allow the subject, clinical practitioner, or professional to participate in more than one protocol procedures, the device is programmed to prohibit the subject clinical practitioner, or professional from participating in the one protocol procedure. 
     
     
         80 . The system of  claim 78 , further including a video recording device communicating with the electronic device or the remote server and recording the subject, a clinical practitioner, or a professional accessing the electronic device. 
     
     
         81 . The system of  claim 80 , wherein the video recording device comprises a camera adapted to be controlled by the software application. 
     
     
         82 . The system of  claim 78 , including a biometric identification apparatus to validate identity of the subject, clinical practitioner, or professional. 
     
     
         83 . The system of  claim 82 , wherein the biometric identification apparatus is selected from the group consisting of: face recognition, fingerprints, retina scan, voiceprint, iris scan, typing biometrics, hand and finger geometry, signature verification, ear geometry, olfactory biometrics, and behavioral biometrics. 
     
     
         84 . The system of  claim 78 , wherein identity data about the subject, clinical practitioner, or professional are stored in the database library. 
     
     
         85 . The system of  claim 78 , wherein the device is programmed to validate identity of the subject, clinical practitioner, or professional by way of: name, social security number, driver's license number, passport number, other government identification documents, address, date of birth, video of the subject, audio of a subject, still image of a subject, and/or biometric identification of a subject.