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.
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%.