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ConsentSolutions Inc. Finalist for GCPj Awards 2007 in the Category...

ConsentSolutions' web-based informed consent application, SecureConsent, was launched in June 2006. This innovative multimedia web approach to informed consent allows trial candidates to review consent materials at their own pace, from home, their physician's office, or a trial site. Studies indicate that multimedia-enhanced informed consent increases enrollment by 50%, increases participant retention by 35%, increases subject understanding by 40%, and requires significantly less researcher time per enrolled subject.

ConsentSolutions' President and CEO, Susan Brink, Dr.PH, notes that "... adult volunteers found SecureConsents' computer-based format to be more comprehensible and accessible than the same trial consent information in paper format. The study subjects also found the additional educational materials and interactive decision tools to be advantages of the computer-based format."

About SecureConsent

SecureConsent uses the IRB-approved document as the foundation for the online consent process. Multimedia content, multi-lingual capabilities and self-assessment tools give candidates with various learning styles and different backgrounds the opportunity to fully explore the possibility of trial participation prior to making a decision. All consent material remains available throughout the course of the trial and can be easily amended.

The consent document is accessed via a trial-specific user name and password. The candidate progresses through the document via a menu. The user has the option to hear the entire page read aloud. Easily accessible embedded material with graphics, animation and narration provides explanations of words, concepts and procedures within the trial context. In each section, the candidate can generate questions, which are compiled in a list and emailed to trial staff or printed. A supplementary section gives the candidate the opportunity to review what they know about the trial and ask questions. An interactive "To Do or Not to Do" learning tool helps users think about what it means to be in that particular clinical trial. They are directed to talk with their trial contact about their questions and concerns prior to signing the consent.

Designed to help clinical trial staff to deliver meaningful, consistent consent information, the SecureConsent back-office allows sponsors, CROs and trial staff to monitor the consenting process across multiple sites and trials in real time. Data can be filtered or visualized in a variety of ways from displaying the progress of individual candidates over time to showing how well the patient population as a whole is proceeding through the consent content.

SecureConsent provides:

-    a customized approach to the production of multimedia consent documents for approval by Institutional Review Boards

-    an enhanced multimedia consent that meets the information and decision needs of potential clinical trial subjects

-    changes, updates, and subject approvals of amended consents in an efficient and timely manner

-    text and narrative in multiple languages

-    consistent presentation of information across the entire subject base

-    email links between investigator, trial staff and subjects for updates and questions

-    tracking and verification of subjects' date, time, and use data

About ConsentSolutions, Inc.

Founded in 2005 and based in Frederick, Maryland, our innovative approach to improving the consent process is winning acclaim from practitioners and patients alike. ConsentSolutions, Inc.'s senior management team has decades of combined experience in specialized health communications, interactive design and programming, and optimized web applications, as well as extensive hands-on experience delivering media-based educational and decision-support materials for patients. ConsentSolutions' initial product SecureConsent was launched in June 2006. ConsentSolutions, Inc., is focused on supporting trial staff and developing interactive, user-friendly software and web sites that help candidates and patients understand and make an informed decision about clinical trial participation. The software is available for institutional licensing and as an ASP solution. The company provides a 21st century multimedia platform for educating potential research participants and assuring their understanding of the trial, while working with sponsors and trial staff to assure optimum presentation of trial information.

About GCPj Awards 2007

The GCPj Awards 2007 honor and reward corporate and individual excellence and celebrate innovation throughout the clinical trial industry, with 12 award categories. The award ceremonies will take place on September 6th in London, England.

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