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Pen-Based Site Visit Reporting Solutions

Digital pens are the preferred workflow of most health care professionals.

March 16, 2010 | Guest Commentary | Clinical Research Associates (CRAs) at most Contract Research Organizations are busier than ever with site monitoring visits, building relationships with PIs and site coordinators, reviewing case report forms and various other tasks. According to a recent salary survey, 57% of CRAs feel their workload has increased in the past year. The heavy workload of managing multiple studies and sites, maintaining relationships, resolving issues, plus extensive travel lead to burnout and high rates of turnover. Solutions that reduce the number of low value-add tasks in workloads and improve efficiency are crucial to streamlining clinical studies and reducing costs. Automating the site visit reporting process is one such area of potential improvement. 

Despite having laptops, most monitors still collect data on paper as they make their visits, manually transcribing the data later on into Word documents or web-based monitoring systems. The visit data are usually keyed into visit reports in hotels or airports and routed to managers and supervisors for approval—a process that can take weeks. This delays understanding any key issues for sites and monitors to resolve, not to mention study trend analysis and invoicing.

Why do monitors continue to collect site visit report data on paper? Although some CTMS vendors now provide offline site monitoring modules, many do not, and the ones with such modules typically provide menu-driven entry screens that are not intuitive or user friendly. In addition, some of these modules are available online only, and CRAs cannot rely on constant internet access.

Pen Preference

The preferred workflow of most health care professionals continues to be pen-based, not keyboard-based. “Clinicians aren’t typers—they are writers,” says Amy Abernethy, program director of the Duke Cancer Care Research Program. “Some health systems are using EMRs that require clinicians to type, and they are doing it—true. But for the most part, there is a growing unrest that our ability to communicate is reliant on typing skills, and that the computer is coming between clinician and patient.”

Susan Brief, former CRA manager at Medtronic, adds that pen-based reporting impacts the efficiency and accuracy of site monitoring “by offering improvements such as reducing or eliminating transcription errors, rework, risks of lost documents and delays to completion.”

Several technologies have been developed recently that address this issue of EDC in a clinician-friendly manner with electronic pen-on-paper systems, including the Digital Pen and Tablet PC.

Based on technology from Sweden’s Anoto, the Digital Pen looks like a regular ballpoint pen, but contains an integrated digital camera, an advanced image microprocessor, and USB connection or Bluetooth wireless capability. Users write on paper, which contains a nearly invisible, unique dot pattern in the background of every page. The camera takes digital snapshots while the user is writing, capturing enough data to determine the exact position of the pen, what it writes or draws, the time each pen stroke was made, as well as the identity of the paper form. The data are retained in the pen’s memory, up to many pages of handwritten data at a time. Once finished, the pen can be docked to a PC where the data can be downloaded and processed by special software with handwriting capture and processing capability. (By docking the pen to charge each evening, data is uploaded, supporting entry of data within 24 hours). A new Digital Pen, the LiveScribe, records handwriting and audio, providing strong potential for high utility in health care applications where handwritten and dictated notes are preferred.

A Tablet PC has a special digitizer screen that allows users to handwrite with a pen-like stylus. These computers, available from Dell, HP, Equus, Lenovo and others are widely available and run Windows 7, Vista or XP Tablet PC Edition. Convertible tablets include full keyboards and have a screen that swivels and locks down for mobile handwritten tablet input. Slate tablets include a “virtual” keyboard where letters and numbers can be tapped out if needed. Using a Tablet PC with wired or wireless Internet connection allows a form to interface with the database to import demographics using abridged information and selecting “Lookup,” for pre-defined parts of the form to be auto-populated from the appropriate fields in the database.

Utilizing these mobile devices, special pen-based data collection software is available to allow users to enter site visit data into paper-like forms, yet have immediate electronic data with no manual keying tasks. With Tablet PC, the software can include live edit checks to ensure that the forms are complete and correct. With digital pens, edit checks can be run upon docking. Reports can automatically be routed to appropriate managers for review and approval, and action items can be compiled into reports or sent to Outlook tasks for follow-up. Finally, completed and approved visit report information can be seamlessly fed into accounting systems for invoicing tasks.

Automating the complex site visit reporting process with pen-based e-forms solution benefits both the organization and its monitors. And being a ‘bolt-on’ for existing applications such as CTMS or EDC systems, these solutions can complement existing systems.

Gautham Pandiyan is an eClinical Marketing Specialist at Mi-Co. He can be reached at 

This article also appeared in the March-April 2010 issue of Bio-IT World Magazine.
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