A Solution for Paperless Data Capture for Electronic Medical Records and Controlled Clinical Trials


Paper Forms in the Health Care System and Controlled Clinical Trials

At present, over 75% of all data acquired in controlled clinical trials, EMR systems, and related clinical environments are entered onto paper forms at the POC, starting a paper trail that imposes fundamental workflow inefficiencies and enormous costs. Replacing paper as a data capture modality has become the "Holy Grail" of both the pharmaceutical services industry as well as the EMR industry. This has proven to be extremely difficult. Off-the-shelf Tablet PCs, Slate PCs (even the latest models), PDAs, and other handheld devices, designed for horizontal consumer markets, have proven useful for accessing information and simplified data entry, but do not approach the threshold for true clinical utility and are not an acceptable replacement for full-size paper forms.

The Burden of Paper in Controlled Clinical Trials

Controlled clinical trials require the collection of vast amounts of information on each participant. Most information is initially recorded on paper, defining a "source document." Currently, all source documents such as screening evaluations, medical examinations, psychiatric rating scales (e.g. PANSS, CIBIC), concomitant medications, etc., consist of paper forms. Subsequently, every data point must be manually transferred to a second paper form, defining a Case Report Form (CRF). CRFs are summary documents created from source documents by clinical study coordinators to report to study sponsors and satisfy regulatory agency requirements. Manually creating a CRF (transcribing source documents manually) can take as much, if not more time, than the originating activity itself. In controlled clinical trials, direct electronic capture at the POC eliminates the need for manually-created CRFs. Acquiring a clinician’s or researcher’s entries at point-of-contact not only achieves immediate conversion to the digital domain and storage in relational database, but also enables a range of post-acquisitions operations such as electronically-indexed access, network-based data transmission, centralized archiving, and cross-enterprise data sharing. Further, computerized post-acquisition processing of an electronically-based source document greatly increases the efficiency of error identification and can automatically create a secure audit trail.

Electronic Data Capture in Clinical Trials:
the Halfway Point to True Efficiency

Electronic Data Capture (EDC) has enabled more rapid collection and review of clinical trial data. However, contemporary EDC has multiple limitations, the most important of which is the reliance on paper forms for primary data capture. Once data is captured onto paper forms, each entry (e.g. digital value) is manually typed onto a web form. Contemporary EDC can be labeled “paper-to-EDC” as the electronic capture process is, in reality, one large, critical step removed.
Accordingly, direct EDC (dEDC™) offers the following fundamental advantages over current "paper-to-EDC" solutions ():
  1. Eliminates paper source documents
  2. Eliminates manual transcription and double-data entry
  3. Eliminates source verification processes
  4. Improves quality/accuracy of data collected
  5. Reduces number of queries by validating data upon entry
  6. Enables immediate evaluation/audit
  7. Reduces need for and time required to perform on-site monitoring
  8. Reduces time from Last Patient/Last Visit (LPLV) to database lock (DBL)
In the figures below, the differentiation between contemporary EDC and direct EDC is presented.

Contemporary EDC Clinical Trial


ClinTab Implemented Trial


Existing Tablet and Slate PC’s

PC manufacturers offer a range of “tablet PC” (tPC) devices in both “convertible” (pen-entry-enabled notebook PC) and “slate” (single, integrated panel) form factors. Some convertibles offer full 8.5" x 11" displays (corresponding to 14.1" LCD diagonal size), but are far too heavy (typically, 4-6 lbs.) and generate too much heat to serve as a practical replacement for paper forms.
Currently available slate PCs are essentially reconfigured notebook PCs and are not suitable as a platform for wide-ranging translation of paper forms into “active” electronic forms for the health care research and clinical environments. Slate PCs designed for large, horizontal consumer markets are:
  • Too heavy (3-6 lbs)
  • Limited by screen size
  • Too hot to hold comfortably
  • Limited by relatively short battery life


ClinTab is an integrated hardware-software solution for optimal POC data capture and processing. The main design objectives are to:
  1. Replace paper forms in electronic medical records systems and clinical trials with cost-effective, FULL-SIZED, electronic equivalents
  2. Facilitate the integration of point-of-care, direct electronic data collection processes within a framework of comprehensive eClinical Solutions to streamline the overall clinical workflow for both controlled clinical trials as well as electronic medical records.
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