ePC

paper-based-clinical-trials

Paper based clinical trials

Capturing high volumes of patient data from case report forms, patient surveys, and questionnaires during paper based clinical trials is a time-consuming and labour-intensive task.

eClinical is a hybrid data capture system that combines traditional paper-based data collection (PBDC) with electronic data capture to enable you to process patient data efficiently without compromising accuracy, reliability, or audibility.

For paper-based surveys, eClinical reads paper case report forms via a high-volume document scanner and/or fax server to extract data, record marked diagrams, spot mistakes and verify data before automatically exporting the results into your existing databases.

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Clients

  • York Teaching Hospital
  • Keele University
  • SPD Development Company
  • University Of Bristol
  • London School of Hygiene and Tropical Medicine
  • Menafricar
  • Cardiff University
  • UCL
  • University of Roehampton
  • University of Exeter
  • University of Oxford
  • Plymouth University
  • NHS Wales
  • KCL

    How it works

    Design

    Build attractive and functional paper questionnaires, surveys, and case report forms (CRFs) in a user-friendly CRF designer to meet trial protocol and standard operating procedures (SOP).

    The form templates will include cornerstones, barcodes, brightness bars and ID blocks to improve the processing of the scanned form with higher capture rates and reduced exception handling.

    Merge & print

    Merge existing datasets onto the template to print forms pre-filled and barcoded, ready for distribution.

    Capture

    Once the forms have been created, printed, and filled in, they need to be converted from paper to an electronic image.

    This is achieved by scanning paper forms on-site or centrally using high-speed document scanners, rather than manually transcribing data.

    Classify

    Once the images are captured, the system will identify the form based on identification blocks, bar codes, or the layout of the page.

    At this stage, the image files undergo image conversion and pre-processing including confirming barcode readability, checking page size and orientation, converting colour images to black and white for best recognition results, and removing image defects e.g., noise and stray marks.

    Extract

    After identifying the template, handprint (ICR), machine print (OCR) and checkbox (OMR) recognition technology extracts and interprets field data from a scanned document. This will include constrained print, tick boxes, variable scales, comments, tick boxes and signatures.

    The system checks rules - including alpha, numeric, dictionaries, date ranges, database lookups and mandatory fields - with exceptions queued for human review.

    The entire process takes seconds - with thousands of forms processed every day.

    Verify

    If human verification is required, scanned images of any field or form needing review are displayed in a high-speed interface for an operator to confirm or correct the data.

    Only invalid data and unrecognisable handwriting is shown to an operator to minimise keystrokes.

    Export

    Export verified data to the Trial Master File (TMF), clinical trial management software (CTMS), or common format (e.g., Excel, CSV, XML or SPSS).

    If the data needs exporting to an in-house patient database, our team has years of experience developing integration components, making it easy for you to access and update information.

    Archive

    Archive scanned images and verified data for instant retrieval later to support regulatory compliance without the need to keep vast amounts of paper originals.

    Example CRFs for paper based clinical trials

      How to optimise paper case report forms (pCRF) for scanning

      A well-designed template improves the processing of the scanned form, reduces manual intervention, and increases capture rates during paper based clinical trials.

      Choice fields

      Choice fields can accept a single choice (e.g. yes or no) or multiple choices (e.g. select all that apply).

      Choice fields offer an array of different styles including bubbles, boxes, underlines, responses and brackets for the recipient to mark.

      Cornerstones

      Cornerstones will assist with page alignment, de-skewing images and adjusting for print or scan size variations.

      Constrained print fields

      Handwriting is most effectively read by ICR (Intelligent Character Recognition) technology when it is laid out in a constrained print field, with one character per box.

      Constrained print fields can gather data such as names, dates, and numeric figures. The boxes act as guides for the person filling out the form, ensuring clear, readable handwriting is used.

      Capture zones

      Capture Zones are typically used to capture blocks of cursive handwriting or other unquantifiable data. They are presented to the operator to allow high-speed coding or re-keying of the content. Advanced features, such as mark identification or predictive typing, help speed up this process.

      Image zones

      Image zones can capture machine-print text, barcodes and pictures. This element is often used to capture printed address labels, barcodes or provide images of handwritten comments.

      Form identification block

      Form identification blocks help with page rotation (where the sheet is scanned upside down) and answer sheet identification for reconciliation. It will also help with version control should future versions of the form need to be used in parallel with older but very similar forms.

      Barcode

      TeleForm can recognise all standard barcode types, including 2D matrix barcodes. These can be added to your form to identify respondents.

      Unconstrained Likert scale

      An unconstrained Likert scale (named after Rensis Likert) can be used to allow respondents to provide a rating or response without subconscious bias caused by limiting ratings to pre-defined values within a range.

      • Choice fields

        Choice fields can accept a single choice (e.g. yes or no) or multiple choices (e.g. select all that apply).

        Choice fields offer an array of different styles including bubbles, boxes, underlines, responses and brackets for the recipient to mark.

      • Cornerstones

        Cornerstones will assist with page alignment, de-skewing images and adjusting for print or scan size variations.

      • Constrained print fields

        Handwriting is most effectively read by ICR (Intelligent Character Recognition) technology when it is laid out in a constrained print field, with one character per box.

        Constrained print fields can gather data such as names, dates, and numeric figures. The boxes act as guides for the person filling out the form, ensuring clear, readable handwriting is used.

      • Capture zones

        Capture Zones are typically used to capture blocks of cursive handwriting or other unquantifiable data. They are presented to the operator to allow high-speed coding or re-keying of the content. Advanced features, such as mark identification or predictive typing, help speed up this process.

      • Image zones

        Image zones can capture machine-print text, barcodes and pictures. This element is often used to capture printed address labels, barcodes or provide images of handwritten comments.

      • Form identification block

        Form identification blocks help with page rotation (where the sheet is scanned upside down) and answer sheet identification for reconciliation. It will also help with version control should future versions of the form need to be used in parallel with older but very similar forms.

      • Barcode

        TeleForm can recognise all standard barcode types, including 2D matrix barcodes. These can be added to your form to identify respondents.

      • Unconstrained Likert scale

        An unconstrained Likert scale (named after Rensis Likert) can be used to allow respondents to provide a rating or response without subconscious bias caused by limiting ratings to pre-defined values within a range.

        Testimonials

        stars

        Teleform/ePC have been the lynchpin of data collection in our home diagnostic clinical trials for many years. As a small team, the software has given us cost-effective and flexible control to manage a diverse range of paper-based trials using a fully-featured form designer with support for downstream verification workflows all the way to export, while ePC have been instrumental in managing and maintaining the service availability with a high standard of professionalism and technical capability

        SPD Swiss Precision Diagnostics GmbH

        stars

        The data capture is much faster and more accurate. More often than not, forms go through without the need to review them. Any issues are usually related to the design of the form or participants not understanding the question or answering it in a way that was not intended. Many users have said the verification process is not only more accurate, it is less of a chore; they actually enjoy verifying now

        Jo Smith, Database Interface Manager, Keele CTU

        stars

        ePC are making a valuable contribution to our aim of running clinical trials in an efficient and cost effective manner

        Dr. Ingrid Potyka, Senior Clinical Operations Manager, UCL

        stars

        Prior to the launch of the study, our requirements changed frequently and deadlines were very tight. ePC have been very supportive in dealing with these design changes. This is not a typical project but ePC have risen to the challenge and I am happy with the progress achieved so far

        Arouna Woukeu, IT Manager, London School of Hygiene and Tropical Medicine (LSHTM)

        Keele University

        keele-university

        Keele University

        Keele CTU saves time by capturing data from their clinical trials with TeleForm.

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        Case studies

        University of Bristol

        University of Bristol

        Based at the University of Bristol, the ‘Children of the 90s’ study uses TeleForm to capture data from the paper versions of their questionnaires.

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        London School of Hygiene and Tropical Medicine

        London School of Hygiene and Tropical Medicine

        MenAfriCar and the London School of Hygiene and Tropical Medicine use TeleForm to study meningococcal carriage in the African meningitis belt.

        Read more

        Verified product reviews