Management and tracking solution for specific patient consent attributes and permissions

A non-transitory computer readable medium encoded with a computer program that comprises instructions to cause a processor to manage consent given by subjects to events in a study, wherein the events are described by attributes including values, and wherein the values are changeable, including to:

• author a first data form describing the attributes and the respective values, and a second data form to permit the subjects to consent to the values of the attributes;
• combine the first data form and the second data form into an informed consent form (ICF) for each of the subject;
• obtain consent of each of the subjects to the respective ICF;
• generate a manifest for each of the subjects, wherein each manifest includes the attributes and the values of the study to which the respective subject has consented, wherein each manifest further includes a version number of the attributes and the values, and wherein the version number changes when the values of the attributes change;
• repeat the combining, the obtaining, and the generating when an attribute and/or a value of the first data form is modified to provide a re-generated manifest for each of the subjects who consents to the modified attribute and/or value;
• and
• generate a report based on the re-generated manifests, wherein the report includes a listing of the subjects, values consented to, and a consent status for each subject based on the version number of uniqueness of the attributes and the values.

A machine-implemented method of managing consent given by subjects to events in a study, wherein the events are described by attributes including values, and wherein the values are changeable, the method comprising:

• authoring a first data form describing the attributes and the respective values, and a second data form to permit the subjects to consent to the values of the attributes;
• combining the first data form and second data form into an informed consent form (ICF) for each of the subjects;
• obtaining consent of each of the subjects to the respective ICF;
• generating a manifest for each of the subjects, wherein each manifest indicates the attributes and the values of the study to which the respective subject has consented and a version number of the attributes and the values, and wherein the version number changes when the values of the attributes change;
• re-authoring the first data form to modify the attributes and/or the respective values;
• combining the re-authored first data form and the second data form into an additional ICF for each of the subjects;
• obtaining indications of re-consent from one or more of the subjects to the modified attributes and/or the respective values with the respective additional ICF;
• re-generating the manifest for each subject, wherein each re-generated manifest indicates the attributes and the values of the study to which the respective subject has re-consented and the version number of the attributes and the values;
• and
• generating a report listing the plurality of subjects based on the manifests and the re-generated manifests, wherein the report includes a listing of the subjects, values consented to and/or re-consented to, and a consent status for each subject based on the version number of the attributes and the values.