News Column

Researchers Submit Patent Application, "Enhanced Monitoring", for Approval

August 25, 2014

By a News Reporter-Staff News Editor at Clinical Trials Week -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors Guthrie, JR., Billye (Santa Clara, CA); Creech, John W. (Santa Clara, CA); Ornelas, Leslie (Santa Clara, CA); Haudek, Dana (Santa Clara, CA); Lewis, Christopher (Santa Clara, CA), filed on January 31, 2014, was made available online on August 14, 2014 (see also Patents).

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: "The disclosed subject matter relates to a system for enhanced monitoring of data during a variety of medical investigations and/or procedures. Particularly, the present disclosed subject matter is directed to risk-based monitoring during clinical trials.

"The presently disclosed subject matter provides for efficient and effective monitoring, while eliminating practices that may not be of value in assuring human subjects protection and reliable and informative study results. The enhanced monitoring model disclosed herein increases productivity and efficiency by decreasing the frequency of on-site monitoring visits and employing remote review techniques to focus on the medical process as compared to individual data points.

"Conventional clinical study monitoring needs to evolve to keep pace with the changing landscape which includes: increased complexity of studies; increased complexity of regulations; rapid advancement of medical technology (e.g. Electronic Data Capture (EDC), Electronic Medical Records (EMR), Electronic Health Records (EHR), etc.); increased demand on resources; and increased scrutiny by media and regulators.

"Several regulatory aids and guidelines are available to practitioners, which include: Clinical Trials Transformation Initiative (CTTI): Effective and Efficient Monitoring as a Component of Quality Assurance in the Conduct of Clinical Trials (available at e-and-efficient-monitoring-as-a-component-of-quality) FDA: Guidance for Industry Oversight of Clinical Investigations--A Risk-based Approach to Monitoring (available at RegulatoryInformation/Guidances/UCM269919.pdf) European Medicine Agency: Reflection paper risk based quality management in clinical trials (available at /2011/08/WC500110059.pdf.) CPGM 7348.810: Sponsors, Contract Research Organizations and Monitors (available at 77.htm) CPGM 7348.811: Clinical Investigators and Sponsor-Investigators (available at 62.htm.

"An overarching goal of the disclosed subject matter is to enhance human subjects' protection and quality of clinical trial data using a risk-based monitoring approach which relies on a combination of monitoring strategies, including greater reliance on centralized monitoring with correspondingly less emphasis on on-site monitoring. The monitoring plan should be tailored to the needs of the trial and the protocol should clearly identify those procedures and data that are critical to subject safety and the integrity and reliability of the study findings. In addition the monitoring plan may include a schema identifying those subjects targeted for on-site review.

"Accordingly, the disclosed subject matter provides improved techniques to ensure that limited resources are best targeted to address the most important issues and priorities, especially those associated with predictable or identifiable risks to the wellbeing of trial subjects and the quality of trial data."

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors' summary information for this patent application: "The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description, as well as from the appended drawings.

"The Enhanced Monitoring (EM) method disclosed herein allows clinical trial Sponsors to have better oversight of site activity earlier by ensuring Remote Review (RR) of data is performed. This method allows better Sponsor oversight by identifying any issues or trends early in the study and between onsite Sponsor monitoring visits. In addition, this method allows the Sponsor to continuously review and 'clean' data as they are entered so that at critical time points in the trial, the database can be locked and available earlier for data extractions for regulatory submissions, publications & presentations.

"Enhanced Monitoring (EM) is a new approach to monitoring of medical studies and procedures (e.g., clinical trials). EM includes a combination of on-site monitoring which includes Targeted Source Data Verification (TSDV) as well as Remote Review (RR). Utilization of EM allows the Clinical Research Associates (CRAs) to focus their efforts on the review of critical safety and efficacy variables and ensuring overall site management and compliance. In accordance with an aspect of the disclosure, an Enhanced Data Review Plan (EDRP) tool is provided which provides collaboration between the CRA, Clinical Data Management (CDM), and Safety groups. The EDRP lists each data point that is included in the electronic case report forms (eCRF), and then shows which group/groups (CRA, CDM, Safety) will be reviewing that particular data point.

"Accordingly, the EDRP serves to decrease the overlap in data review by the three groups in order to increase efficiency and decrease costs. In accordance with another aspect of the disclosure, a suite of metric reports is provided that allow for the oversight and management of sites and studies using the EM approach.

"According to an embodiment of the present disclosure, a system for monitoring a clinical trial is provided. The system includes a data input terminal. The data input terminal is located at a data collection point and includes a plurality of input validation rules. The data input terminal receives data from a user. The data has a datatype. The data input terminal applies at least one of the plurality of input validation rules to the data. The system includes a first datastore receiving data from the data input terminal. The system also includes a data analysis server. The data analysis server includes a plurality of data validation rules. The server received the data from the first datastore and applies at least one of the plurality of data validation rules to the data to obtain a result. The server includes a plurality of triggers. The server initiates at least one of the triggers based on the result of the application of the at least one of the plurality of data validation rules.

"According to another embodiment of the present disclosure, a method and computer program product for monitoring of clinical data is provided. A plurality of rules is read from a rulebase. Input data is read. The input data comprises a plurality of values. The plurality of rules is applied to the input data to determine an indicator for each of the values. The indicator for each of the values indicates whether the value is erroneous. Based on the indicators for each of the values, at least one trigger is initiated.

"It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the disclosed subject matter.

"The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the disclosed subject matter. Together with the description, the drawings serve to explain the principles of the disclosed subject matter.


"A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and are not necessarily drawn to scale, with some components and features being exaggerated for clarity. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.

"FIG. 1 is a system diagram of an Enhanced Monitoring system in accordance with the disclosed subject matter.

"FIG. 2 is an exemplary flow chart of the Enhanced Monitoring system in accordance with the disclosed subject matter.

"FIGS. 3A-3C are an exemplary Data Monitoring Guideline highlighting representative variables for remote review, onsite review and logic checks. FIG. 3A depicts header information, as well as representative variables for remote review and onsite review. FIG. 3B depicts additional representative variables for remote review. FIG. 3C depicts additional representative variables for review, as well as representative variables for logic checks."

For additional information on this patent application, see: Guthrie, JR., Billye; Creech, John W.; Ornelas, Leslie; Haudek, Dana; Lewis, Christopher. Enhanced Monitoring. Filed January 31, 2014 and posted August 14, 2014. Patent URL:

Keywords for this news article include: Patents, Legal Issues, Information Technology, Clinical Trials and Studies, Information and Data Validation.

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Source: Clinical Trials Week

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