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US 10,706,015 B2Granted
System and method for managing a workflow for biomedical development
AssigneeYuehua Cao
InventorYuehua Cao
Life of this patent
Estimating the term…
Abstract
A method and system for managing a workflow for producing a biostatistical analysis (BA) of biomedical data. The data originates from a milestone (or snapshot) of a clinical study performed by, or on behalf of a life science company that performs the BA. The data may be from a blinded or un-blinded clinical study. SAS programs are used for the BA. An audit trail is produced to track changes to any of the data or programs used during the course of the workflow. The programs and data used to produce reported results from the BA are stored in electronic format for sending to a regulatory agency.
Claims19
A system for managing a workflow for biomedical development, the system for managing the workflow comprising:
- a processor;
- one or more input devices;
- a desktop application having machine executable code, residing in non-transitory memory accessible to the processor, that when executed by the processor performs the following tasks in response to input received through the one or more input devices:
- create and make changes to workflow data used during the workflow, the workflow data comprising SAS programs used to produce biostatistical output from biomedical data, the workflow data being categorized and maintained under a life science program and a blind study or an un-blind study under the program, the blind or un-blind study producing the biomedical data, and further characterized under a milestone for the study;
- create and make changes to a SAS program data structure comprising one of the SAS programs and metadata associated with the SAS program, the metadata including:
- (a) a location for SAS source code, input files and output files,
- (b) a designated at least one programmer responsible for creating, updating and/or validating the source code during the course of the workflow, and
- (c) a status indicating whether the source code is available for use, or not ready for use;
- create or add to an audit trail for the SAS program data structure during the course of the workflow, wherein if a change is made in the SAS program data structure, storing in memory an audit trail record containing information about the change, including
- (1) a user that made the change,
- (2) when the change was made, and
- (3) a type of change that was made.
9 more elements
An apparatus comprising machine executable instructions or code stored in non-transitory memory that when executed by one or more processors performs the following method in response to input received from an input device,
- create and make changes to workflow data used during a workflow, the workflow data comprising SAS programs used to produce biostatistical output from biomedical data, the workflow data being categorized and maintained under a life science program and a blind study or an un-blind study under the program, the blind or un-blind study producing the biomedical data, and further characterized under a milestone for the study;
- create and make changes to a SAS program data structure comprising one of the SAS programs and metadata associated with the SAS program, the metadata including:
- (a) a location for SAS source code, input files and output files,
- (b) a designated at least one programmer responsible for creating, updating and/or validating the source code during the course of the workflow, and
- (c) a status level indicating whether the source code is available for use, or not ready for use, by a biostatistician that will use the SAS program to produce the biostatistical output;
- create or add to an audit trail for the SAS program data structure during the course of the workflow, wherein if a change is made in the SAS program data structure, storing in memory an audit trail record containing information about the change, including
- (1) a user that made the change,
- (2) when the change was made, and
- (3) a type of change that was made.
6 more elements
A system for maintaining a SAS source file used to perform a biostatistical analysis of biomedical data during the course of a workflow, the system comprising:
- a processor and input device;
- machine executable code, residing in non-transitory memory accessible to the processor, that when executed by the processor performs the following tasks in response to user input received through a graphical user interface generated by the machine executable code and displayable to the user through the user interface:
- create and make changes to a workflow data structure used during the workflow, the data structure comprising
- metadata associated with a SAS program intended for being used to produce biostatistical output from biomedical data, comprising
- a SAS programmer, validating programmer and lead programmer responsible for creating the SAS program,
- a validation level for the SAS program indicating the level of validation needed before the program may be used by a biostatistician to produce the biostatical output, and
- a program status as one of planned, in-development, ready for validation and in-production;
- wherein a method for creating or editing the SAS program includes the following steps in the following order,
- (a) send a first message to the SAS programmer to create or make changes to source code, and set program status to in-production,
- (b) send a second message to one or both of the validating or lead programmer, indicating that source code is ready for review or validation, and change status to ready for validation,
- (c) send a third message to the biostatistician indicating that the SAS program is ready for use by the biostatistician, and change program status to in-production, and
- (d) if change is needed to the source code, repeat steps (a) through (c), thereby restricting access to the SAS program to only the SAS programmer, validating programmer and lead programmer.
9 more elements
Dependencies are inferred from the claim text.