Electronic clinical trial protocol management systems and related methods

A computer-implemented method of interacting with a clinical trial protocol via an electronic clinical trial protocol management system, the electronic clinical trial protocol management system being programmed with information describing a clinical trial protocol for a clinical trial having one or more treatment cycles, the electronic clinical trial protocol management system including one or more programmatic elements that model a number of treatment cycle iterations for a subject progressing through the clinical trial, the method comprising:

• associating an electronic copy of a clinical trial source document with a tracking location in the clinical trial protocol within the electronic clinical trial protocol management system, wherein the clinical trial source document relates to a clinical procedure performed with respect to a subject of the clinical trial, and associating the electronic copy of the clinical trial source document with the tracking location comprises:
• linking the electronic copy of the clinical trial source document to the tracking location via at least one programmatic element representing at least one of a visit, the clinical procedure, a treatment cycle, an iteration of a treatment cycle, and an interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial;
• generating a graphical user interface (GUI) including a first portion and a second portion;
• displaying, via the first portion of the GUI, at least a portion of the electronic copy of the clinical trial source document;
• displaying, via the second portion of the GUI and simultaneously with the displaying of the portion of the electronic copy of the clinical trial source document in the first portion, one or more GUI elements for receiving input of clinical trial information related to the portion of the electronic copy displayed in the first portion and/or the tracking location to which the electronic copy is associated within the electronic clinical trial protocol management system;
• and
• associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location to which the electronic copy is associated, wherein associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location comprises linking the clinical trial information to the tracking location via the at least one programmatic element representing at least one of the visit, the clinical procedure, the treatment cycle, the iteration of a treatment cycle, and the interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial.

An electronic clinical trial protocol management system programmed with information describing a clinical trial protocol for a clinical trial having one or more treatment cycles, the electronic clinical trial protocol management system including one or more programmatic elements that model a number of treatment cycle iterations for a subject progressing through the clinical trial, the electronic clinical trial protocol management system comprising:

• at least one processor;
• and
• at least one machine readable hardware storage medium containing machine executable instructions that when executed by the at least one processor cause the at least one processor to implement a method of interacting with a clinical trial protocol via the electronic clinical trial protocol management system, the method comprising:
• associating an electronic copy of a clinical trial source document with a tracking location in the clinical trial protocol within the electronic clinical trial protocol management system, wherein the clinical trial source document relates to a clinical procedure performed with respect to a subject of the clinical trial, and associating the electronic copy of the clinical trial source document with the tracking location comprises:
• associating the electronic copy of the clinical trial source document to at least one programmatic element representing at least one of a visit, the clinical procedure, a treatment cycle, an iteration of a treatment cycle, and an interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial;
• generating a graphical user interface (GUI) including a first portion and a second portion;
• displaying, via the first portion of the GUI, at least a portion of the electronic copy of the clinical trial source document;
• displaying, via the second portion of the GUI and simultaneously with the displaying of the portion of the electronic copy of the clinical trial source document in the first portion, one or more GUI elements for receiving input of clinical trial information related to the portion of the electronic copy displayed in the first portion and/or the tracking location to which the electronic copy is associated within the electronic clinical trial protocol management system;
• and
• associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location to which the electronic copy is associated, wherein associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location comprises linking the clinical trial information to the tracking location via the at least one programmatic element representing at least one of the visit, the clinical procedure, the treatment cycle, the iteration of a treatment cycle, and the interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial.

A machine readable hardware storage medium containing machine executable instructions that when executed by at least one processor of an electronic clinical trial protocol management system cause the at least one processor to implement a method of interacting with a clinical trial protocol via an electronic clinical trial protocol management system, the electronic clinical trial protocol management system being programmed with information describing a clinical trial protocol for a clinical trial having one or more treatment cycles, the electronic clinical trial protocol management system including one or more programmatic elements that model a number of treatment cycle iterations for a subject progressing through the clinical trial, the method comprising:

• associating an electronic copy of a clinical trial source document with a tracking location in the clinical trial protocol within the electronic clinical trial protocol management system, wherein the clinical trial source document relates to a clinical procedure performed with respect to a subject of the clinical trial, and associating the electronic copy of the clinical trial source document with the tracking location comprises:
• associating the electronic copy of the clinical trial source document to at least one programmatic element representing at least one of a visit, the clinical procedure, a treatment cycle, an iteration of a treatment cycle, and an interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial;
• generating a graphical user interface (GUI) including a first portion and a second portion;
• displaying, via the first portion of the GUI, at least a portion of the electronic copy of the clinical trial source document;
• displaying, via the second portion of the GUI and simultaneously with the displaying of the portion of the electronic copy of the clinical trial source document in the first portion, one or more GUI elements for receiving input of clinical trial information related to the portion of the electronic copy displayed in the first portion and/or the tracking location to which the electronic copy is associated within the electronic clinical trial protocol management system;
• and
• associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location to which the electronic copy is associated, wherein associating the clinical trial information input via the one or more GUI elements in the second portion of the GUI to the tracking location comprises linking the clinical trial information to the tracking location via the at least one programmatic element representing at least one of the visit, the clinical procedure, the treatment cycle, the iteration of a treatment cycle, and the interval of an iteration of a treatment cycle for the progression of the subject in the clinical trial.