Paper CRF vs eCRF: What Really Changes

For many years, paper-based materials were used to collect and process clinical data: case report forms completed at investigative sites, handwritten corrections, data entry forms sent for processing, double data entry, and paper Data Clarification Forms (DCFs) exchanged between teams.

The arrival of the eCRF (electronic Case Report Form) profoundly changed this organisation. This evolution is not simply about replacing paper with a screen and keyboard. An eCRF transforms how data is collected, circulated, reviewed and made ready for use.

Let us look at what this means in practice for the different stakeholders involved in a clinical study.

For the investigative site: easier data collection

With a paper CRF, data is recorded in a case report form dedicated to each patient. Depending on the number of patients, visits and data points to be collected, these files can quickly become bulky and require a significant amount of secure storage space.

Completing them also requires strict rules to be followed: entering data in the expected format, avoiding unplanned annotations, never using correction fluid, and preserving the original entry whenever a correction is made by dating and initialling it. These constraints can lead to errors or make information difficult to read.

With an eCRF, data is entered directly into a centralised, secure electronic environment. There is no longer any need to store physical case report forms: a computer and an internet connection provide access to the system through secure, individual user permissions.

A well-designed eCRF also guides users as they enter data through mandatory fields, expected formats, drop-down lists, automatic calculations and the conditional display of relevant fields. Data entry is therefore simpler and better controlled, helping to prevent certain errors and improve the quality of the collected data.

For the CRA: an up-to-date view of collected data

With a paper CRF, a Clinical Research Associate's access to study data largely depends on on-site visits. Checking requested corrections often requires returning to the site and reviewing the case report forms again.

With an eCRF, the CRA can access entered data remotely, monitor completeness and quickly identify missing forms.

Correction requests can be issued directly within the eCRF as queries linked to the relevant data point or form, and then followed up remotely. This helps the CRA prepare site visits more effectively and focus on the data, patients or activities that require particular attention.

The eCRF therefore becomes a genuine monitoring preparation and oversight tool, especially valuable within a risk-based monitoring approach.

For the Data Manager: from data entry to database design and continuous data review

Moving from paper to an eCRF changes the role of Data Management.

In a paper-based organisation, a substantial part of the work involves receiving and reviewing CRFs before entering the collected information into an electronic database. This transcription process is time-consuming and can itself introduce errors.

With an eCRF, more effort is directed towards database design and configuration, drawing on the Data Manager's expertise: translating the protocol into a data structure, designing the forms, defining data-entry rules and consistency checks, and anticipating the needs of both monitoring and statistical analysis.

Once the study is under way, data is available electronically as soon as it is entered. Automated checks can rapidly identify missing, inconsistent or outlying values and allow the site to be contacted close to the time of collection.

Automation also reduces repetitive manual checks. The database can therefore be cleaned progressively throughout the study, instead of concentrating this work immediately before interim analyses or study close-out.

This continuous control makes it possible to obtain a complete, consistent database ready for statistical analysis more quickly.

For the project manager and sponsor: real-time study oversight

How many patients have been enrolled? How many visits have been completed? Is data being entered on time? How many queries remain open?

With paper records, answering these questions often means consolidating information from several contacts, and that information may not reflect the study's latest status.

An eCRF provides a centralised, up-to-date view of study activity. Depending on the available features, dashboards and indicators can be used to monitor enrolment, data completeness, site activity and query status.

Data therefore contributes directly to the operational oversight of the study.

With every correction: preserving the history of the data

Clinical research data may change. On paper, every correction must leave the original entry legible and be properly documented, notably with a date and initials. However, repeated corrections can make some forms difficult to read and use.

In an electronic system designed for clinical research, changes are recorded in an audit trail, automatically preserving the history of the data: who changed what, when and why.

This traceability helps ensure data integrity and reliability.

Behind the scenes: reducing the logistics surrounding data

Another major benefit of an eCRF is the reduction in all the logistics associated with case report forms.

With paper, forms must be prepared, printed and shipped to sites, then collected during the study. Copies must be managed, documents sent to the sponsor or CRO, and records filed and archived.

The management of Data Clarification Forms (DCFs) adds another workflow: issuing, sending, answering, retrieving, processing and filing each form.

When multiplied by the number of patients, visits and sites, these operations quickly become a significant volume of administrative and logistical work.

With an eCRF, many of these flows disappear or are integrated directly into the platform. Data and clarification requests are centralised and available to the relevant stakeholders according to their access rights.

Less paper therefore means less printing, fewer shipments, less handling and less time spent on CRF document management.

What about the budget? Comparing the cost of a digital tool with the true cost of paper

An eCRF solution involves visible costs: database design and configuration, validation, hosting, potential licence fees, maintenance and support.

However, comparing these costs only with the price of printing forms gives an incomplete picture. Paper also has a total cost, some of which is less visible:

• shipping and retrieving CRFs;
• filing, managing and archiving documents;
• tracking missing CRFs;
• single or double data entry into an electronic database and the related checks;
• creating, sending and processing paper DCFs;
• the time spent by study teams and investigative sites managing all these flows.

A meaningful economic comparison should therefore not contrast “the cost of an eCRF” with “the printing cost of paper”, but rather compare the total cost of both operating models.

Paper may still make economic sense for a very simple, single-centre study involving limited data. However, as the number of sites, participants, visits or data points increases, the staff time and logistical costs associated with paper rapidly become significant.

An eCRF is therefore a technological investment, but in return it can help reduce manual tasks and optimise the teams' time.

Ultimately, what does an eCRF really change?

An eCRF does more than eliminate paper case report forms. It transforms the entire data lifecycle: collection, review, circulation, correction, monitoring and preparation for analysis.

It also streamlines the organisation surrounding the data: fewer documents to circulate, less re-entry, fewer administrative tasks and faster access to information.

Nevertheless, the tool alone cannot guarantee data quality. The performance of an eCRF depends above all on its design: understanding the protocol, defining the right data to collect, ensuring usability for investigative sites, establishing an appropriate control strategy, and anticipating the needs of monitoring, Data Management and statistical analysis.

A good eCRF is therefore not simply a CRF freed from the constraints of paper. It is a tool designed to simplify the work of study teams while improving control over clinical data.

At Axiodis CRO, this approach is based on close collaboration between Clinical Operations, Data Management and Biostatistics teams from the study design stage onwards. Our objective is to provide tools tailored to each project's objectives and to the needs of the people who use them.