Electronic case report form

An Electronic Case Report Form is an electronic test form in an Internet database. Data acquisition via the Internet is also called EDC (Electronic Data Capture). Internet databases for clinical trials are usually based on Oracle and are more complex to create than conventional databases.

EDC has many advantages over paper CRFs: data entry can be verified directly by the sponsor or the contract research organisation (CRO). This provides a better overview of patient recruitment and the quality of data entry. There are significantly fewer queries (queries), as problems with illegible handwriting are eliminated. Furthermore, numerous plausibility checks can be programmed in an eCRF, so that many incorrect entries (e.g. entering the current date as date of birth) are not possible at all. This enables online monitoring, in which the data entered via the Internet is checked for correctness and completeness, while monitoring at the study centre focuses on source data verification (SDV), i.e. the comparison of database entries and source documents. Due to the time savings and the user-friendliness for the investigators and study nurses, EDC has established itself in recent years and has become the standard in clinical studies.

eCRFs should be FDA compliant, comply with GCP and ISO 14155 guidelines, have an audit trail (recording of entries or changes to data) and an e-signature. It is important that the databases are forgery-proof, so that e.g. data recordings with unsuitable eCRFs, just like Excel tables, are rejected during audits or official inspections.

In order to create an eCRF, you must have sound computer knowledge. At least as important is a great deal of experience with database creation, so that the database is logically structured, is created in a user-friendly way and does not contain any errors that might only become apparent during or at the end of the study, thus preventing data evaluation. For this reason, Clinical Research Organizations usually take over the database creation, using e.g. the software of SecuTrial®.