Design data collection forms, case report forms (CRFs) and patient questionnaires
The UKTMN advises sponsors and investigators to make paper medical records and data collection forms as attractive and easy as possible to complete. eClinical enables trial teams to develop paper data collection forms, case report forms (CRFs) and patient questionnaires that produce quality data for analysis.
CRF design in clinical trials
It is good practice to have a clear identity for the trial and design data collection forms that clearly state the activity and sponsor branding.
You can start with a blank page and design a patient questionnaire or form using an intuitive drag-and-drop form 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 questionnaire follow your trial or sponsor branding. If you prefer, you can scan an existing data collection form and overlay the structure on top to capture 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 field-by-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 design in clinical trials 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.
Data collection form components
Set up simple tick boxes or multiple option tick boxes in a variety of styles.
Capture images, diagrams or data from multi-line machine print labels.
To confirm if a paper CRF has been authorised with a signature.
eClinical reads handwriting most effectively when it is laid out in a constrained print field, with one character per box.
For quickly capturing more complex fields such as “Other Comments:” by either predictive typing, coding or manual entry.
Many industry-standard barcodes can be read from scanned images, including two-dimensional barcodes such as PDF417.
Paper CRF/questionnaires library
Avon Longitudinal Study of Parents and Children (ALSPAC)
North Cumbria University NHS Hospitals Trust
London School of Hygiene and Tropical Medicine / MenAfricar
London School of Hygiene and Tropical Medicine / MenAfricar
How to optimise paper CRFs and data collection forms for scanning
A well-designed paper CRF or patient questionnaire improves the processing of scanned forms and reduces manual intervention.
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
Barcode
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.
Electronic data capture (EDC)
With the optional eForm module, eClinical can be used as a hybrid paper and electronic data capture (EDC) system.
eClinical allows paper CRF’s to be exported from the CRF Designer as dynamic PDF or HTML forms for end-users to complete on-screen and submit electronically back to the verification module.
We also provide stand-alone EDC systems that simplify compliance with ICH GCP E6 R2 standards and other regulations such as 21CFR Part 11 with online forms, web interfaces, audit trails, access control, version tracking, electronic signatures and more.