To ensure a more efficient patient data collection and study follow-up, clinical research professionals use a CRF (Case Report Form). Long used in paper format, the eCRF (Electronic Case Report Form), its digital version is now unanimously accepted by the players in the sector. So what are the advantages of the eCRF compared to the paper CRF? How is switching to the electronic CRF beneficial for your studies?

The paper CRF, also known as an observation notebook, is used to collect patient data during a clinical trial. This CRF is composed of all the forms necessary for the follow-up of the patients and reports all the reactions, observations and treatment effects.

An eCRF allows online entry of patient data by investigators and Clinical Research Associates (CRAs). The purpose of using an eCRF is to ensure simplicity of data collection, control and traceability to ensure data integrity and accuracy.

The advantages of an eCRF:

  • Consistency and accuracy of data:

Opting for the digital version of a CRF has many significant advantages. Firstly, it ensures the consistency and veracity of the data, eliminating the possibility of errors during manual transcription or misreading.

In addition, the limitation of data entry errors thanks to the field constraints of an eCRF makes it possible to obtain answers in accordance with the clinical investigation plan and therefore more accurate data.

It is also possible to correct or add items during the study without having to re-edit the entire observation notebook.

The data can be verified through queries. A query is an electronic request sent to the investigating team to confirm or alert them to any inconsistencies or potential data entry errors.

  • Data monitoring and score calculation:

Monitoring and remote follow-up is ensured, thanks to pre-established dashboards and monitoring indicators. Automatic notifications sent directly by the eCRF in case of inclusion or adverse events also allows clinical research professionals to track data more easily and regularly.

Scores are also calculated automatically, removing bias in investigator calculations and misinterpretation.

  • Data security:

Access to the eCRF is limited to study stakeholders.Only authorized persons can collect and manage the data.

All entries and modifications are tracked, ensuring traceability and a true audit trail. It is possible to know who changed what and when, which is impossible on a paper CRF.

The data is hosted on secure servers that ensure regular and permanent data backup, unlike paper CRFs which can be lost or altered.

  • Significant time and cost savings:

Data are captured in real time as the eCRF study progresses, whereas they were captured at the end of the patient follow-up period on paper CRFs. This eliminates the need to transcribe case report forms into the database at the end of the study.

Once recorded in the eCRF, the data are easier to manage and intermediate analyses are simplified because they are already in the database.

The eCRF facilitates the work of the investigators while providing them with the most accurate and consistent data possible. In addition to simplifying logistics and organization, the eCRF reduces the costs associated with a study by nearly 20%.

What is Arone eCRF?

Arone eCRF is the data collection tool proposed by Arone, French editor of Cloud solutions dedicated to clinical research management.

It allows clinical trial investigators to enter patient data in a 100% secure web environment. Arone eCRF is part of the Arone EDC platform for the capture, management and monitoring of data related to clinical research. The solution complies with pharmaceutical industry standards (export to SAS, CDISC) and is compliant with 21CFR Part 11.