How eClinical helps with data collection and trial management

The report says “Blank answers should be avoided. Develop forms that are clearly set out and are unambiguous in the instructions”.

In eClinical, a well-designed form consisting of form elements e.g. choice fields, cornerstones, barcodes and ID blocks, will logically guide the user to successful form completion. Additionally, by using fields with explicit “No” values, instead of assuming blank responses are an implicit “No”, will improve accuracy whilst reducing manual intervention.

The guide states “data accuracy depends on a number of factors including the legibility of handwriting and manual transcription errors”.

eClinical captures your data with high accuracy; with any ambiguous characters or fields not meeting your rules being flagged for human verification. With only invalid or unrecognisable handwriting/data being highlighted to an operator for correction, their attention is focused on where it needs to be. This ensures data transcription errors from manually having to transcribe hundreds of fields per form are minimised and all captured data meets your defined rules.

It is noted that “validity depends on whether or not the data has been accurately recorded”.

Once information has been collected, eClinical is able to validate the information against other systems (e.g. databases, web services etc.) and sanity rules to ensure accuracy.

Simple rules such as alpha, numeric, dictionaries, date ranges, look-ups and mandatory fields will be checked with common-sense logic rules applied (e.g. it is impossible to tick more than one response for a single-choice question) so any invalid fields/characters can be queued for human review.

It is recommended to “try to avoid free text boxes where possible as it is difficult to categorise or summarise, it can also be problematic to transcribe from paper to computer”

eClinical provides a number of tools to assist here. If possible, multi-choice tick-boxes should be used to capture the most common options with an “Other…” free-entry zone used only where necessary. Where a free-entry zone is used, eClinical can provide drop-downs to allow a human operator to quickly categorise or code the responses. This combined with an archive of searchable snippets containing the original images of the written response is often enough to meet most needs. Options like predictive text are also available as a way of speeding up capture where manual keying is absolutely required.

On paper, the guide states, “it is straightforward to list a number of options and say ‘tick one box only’” before going on to recommend the use of drop-down lists for electronic systems.

eClinical uses choice fields consisting of single choice (e.g. yes/no) or multiple choice (e.g. select all options that apply) fields. Although eClinical supports flexible designs with circles, ovals, boxes or even ‘circle the correct response’ style fields, to improve OMR (Optical Mark Recognition) accuracy, it is generally recommended to use ovals or boxes.

With eCRF and the use of electronic data capture tools in clinical trials, drop-downs are generally a better choice, as they can provide the user with many options in a smaller area of the form design.

The guide states some paper forms use individual boxes for each character to try to force clarity, especially for names and addresses.

Handwriting is most effectively read by ICR (Intelligent Character Recognition) when it is laid out in a constrained print field, with one character per box. The eClinical data capture system uses these print fields to act as guides for the person filling out the form, with one dedicated space for each letter, number or character in the response.

It is important to note, the guide says, where images are collected for the trial, consideration should be given to how these will be generated, transferred, held and subsequently archived. The report adds that image anonymisation can be challenging.

Once exported, verified data and form images can be exported in to eStore for secure storage, archival and retrieval with personal information redacted. It enables users and auditors to perform keyword searches and to retrieve specific documents, or parts of an anonymised document. Access to data is limited to those with appropriate permissions.

In section 5.7 of the Guide to Efficient Trial Management, best practice for the ‘trial database’ and eCRF design is outlined.

eClinical allows PDF and HTML form export from the CRF Designer for end-users to complete on-screen and submit electronically to the verification module. This module exports any form template as an intelligent eCRF. All fields created in the CRF Designer are converted to electronic fill-in fields with field logic and rules automatically applied.

eClinical meets the recommendations. Some key points are noted below.

• You can replicate an existing paper data capture form online to enhance ease and quality of data input
• It is possible to use configurable tabs to minimise the number of screens and avoid excessive scrolling
• Logical field validations will also ensure that forms cannot be submitted with invalid data. If an out-of-range value is entered, a warning will be displayed
• If required, most fields will be mandatory, with explicit no response fields, ensuring the users cannot accidentally miss a field leaving it blank
• Certain fields will auto-calculate, meaning you don’t have to rely on the accuracy of the users maths
• Drop-down lists will be used for multiple choice answers as they need less screen space and restrict the user to inputting only valid responses
• Once submitted, forms can be locked down with users no longer being able to edit or modify any data on the form

The guide promotes the use of computer systems to identify and query out-of-range or invalid data at the point of entry. It encourages use of automated data capture systems.

We quite agree! Although we find there is often a tendency to attempt to identify and correct errors within the resultant data, doing it at this late stage is much more time consuming than at the point of capture as the operator does not have the original image of the completed form in front of them to base any corrective decision on. They will instead have to perform query management, the time-consuming process of tracking down and reviewing the original paper form, which may not even be stored within easy reach.

In section 5.8, it refers to “storage of source data records being required both during and after the trial”.

As a result, the filing requirements associated with paper CRFs for a major trial (with thousands of patients over a number of years) are enormous and trials can require huge storage areas for long periods of time. Not only do the storage costs add up, but how to you ensure timely and compliant record destruction? It is also inherently impossible to back up a paper original, meaning disaster recovery may be impossible, potentially invalidating millions spent on a trial over many years.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted that scanning paper records into a computer system is an acceptable alternative, providing that the computer records are properly indexed and made read-only to avoid tampering.

With eClinical, either unmodified original images or redacted and anonymised images can be exported out to eStore or a third-party storage and retrieval system. This supports trial management and removes the need to store and manage mountains or paper.