CRF design and development

The UKTMN advises sponsors and investigators make paper medical records and data collection forms attractive and as easy as possible to complete. eClinical allows you to design CRF’s that produce quality data for analysis and meet study protocol as well as ICH guidelines for case report forms.

CRF design in clinical trials for ease of completion and use

It is good practice to have a clear identity for the trial and design data capture forms that clearly states the activity and sponsor branding.

You can start with a blank page and design a paper survey, form or questionnaire using the intuitive drag-and-drop CRF designer, adding fields and labels as you go.

Design elements, such as logos, borders, headers and font styles can all be added to make the form follow your trial or sponsor branding. If you prefer, you can scan in an existing data capture form and overlay the structure on top to allow the system to capture your existing designs as well as new forms.

Many of your data collection requirements need to be configured at this stage. Settings for numeric or date ranges, mandatory fields and double keying can be defined on a per field basis, allowing for truly robust results.

How you configure this early stage is key to trial outcomes as it will provide the basis of your information gathering, so take the time to get CRF development right. ePC can offer our extensive experience to help you create scannable forms at this (and any other) stage, depending on the level of support you require.

Electronic case report form (CRF) design

eClinical allows data capture forms to be exported from the CRF designer as dynamic electronic forms (or eCRFs) for end-users to complete in their browser and submit it back to the verification module.

Typical form components

choice-fields

Choice fields

Set up simple tick boxes or multiple option tick boxes in a variety of styles.

images-zones

Image zones

Capture images, diagrams or data from multi-line machine print labels.

signature-zones

Signature zones

To confirm if a paper CRF has been authorised with a signature.

constrained-print-fields

Constrained print fields

eClinical reads handwriting most effectively when it is laid out in a constrained print field, with one character per box.

capture-zones

Capture zones

For quickly capturing more complex fields such as “Other Comments:” by either predictive typing, coding or manual entry.

barcodes

Barcodes

Many industry standard bar codes can be read from scanned images including two dimensional bar codes such as PDF417.

Examples of data capture forms

  • university-of-plymouth

    University of Plymouth

    Validation of Clinical Competency
  • university-of-plymouth

    University of Plymouth

    Diagnosis and Treatment Planning Assessment (DTPA)
  • university-of-plymouth

    University of Plymouth

    Diagnosis and Treatment Planning Assessment (DTPA)
  • western-sussex-hospitals-nhs-trust

    Western Sussex Hospitals NHS Trust

    Variations in Hospital Mortality Project
  • north-cumbria-university-nhs-hospitals-trust

    North Cumbria University NHS Hospitals Trust

    Advancing Quality Hip/Knee Replacement Record
  • nhs-wales

    NHS Wales

    All Wales Medication Safety Monitoring
  • kcl

    KCL

    SentiMAG Multicentre Phase II Trial (Adjuvant Therapy Form)
  • menafricar

    MenAfricar

    Community Characterization Form (CCF)
  • menafricar

    MenAfricar

    Fiche de Recensement de la Population – Partie B (PCF-B)

    If you want to learn more about designing data capture forms and CRF development, or wish to book a demonstration, please contact us.

    How to optimise CRF’s and other trial forms for scanning

    A well-designed CRF or paper questionnaire consisting of form elements e.g. choice fields, cornerstones, barcodes and ID blocks improves the processing of the scanned form and reduces manual intervention.
    demo-form

    Choice fields

    Add a choice field to your form to accept a single choice (e.g. yes/no) or multiple choice (e.g. select option A/B/C/D).

    Choice Fields consist of a single column, or row, of choices and offer an array of different styles including bubbles, boxes, underlines, responses and brackets.

    To improve OMR (Optical Mark Recognition) accuracy, it is recommended to use bubbles and boxes rathar than circling a response or marking within brackets.

    Cornerstones

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

    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.

    Form designers can add a constrained print field to gather data such as names, dates, and numeric figures. The boxes act as guides for the person filling out the form, with one dedicated space for each letter, number or character in the response.

    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.

    Cornerstones

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

    Cornerstones

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

    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

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

    Unconstrained Likert scales

    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

      Add a choice field to your form to accept a single choice (e.g. yes/no) or multiple choice (e.g. select option A/B/C/D).

      Choice Fields consist of a single column, or row, of choices and offer an array of different styles including bubbles, boxes, underlines, responses and brackets.

      To improve OMR (Optical Mark Recognition) accuracy, it is recommended to use bubbles and boxes rathar than circling a response or marking within brackets.

    • Cornerstones

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

    • 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.

      Form designers can add a constrained print field to gather data such as names, dates, and numeric figures. The boxes act as guides for the person filling out the form, with one dedicated space for each letter, number or character in the response.

    • 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.

    • Cornerstones

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

    • Cornerstones

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

    • 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

      eClinical can recognise all standard barcode types, including 2D matrix barcodes. These can be added to your form to identify respondents.
    • Unconstrained Likert scales

      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.

    If you want to learn more about hybrid paper and electronic data capture in clinical trials, or wish to book a demonstration, please contact us.

    © ePartner Consulting Ltd 2004-2020 | Company registration number: 05192543 | VAT number: GB842064740.

    Address: ePartner Consulting Ltd, PO Box 1578, Lightwater, GU22 2UY, United Kingdom. Tel: +44 (0)3300 100 000.

    ePartner Consulting Ltd help you replace manual, paper-driven tasks with automated data capture and BPM software solutions that manage, automate and report on your business processes. Visit our website or view our privacy policy.

    .
    Accreditation's