The electronic Case Report Form (eCRF) is a software, web app or electronic folder that allow to collect data of the clinical trial according to the protocol requirements after that an Informed consent is signed by the Patient.
The electronic data collection of these information need to be performed in systems that are validated according to the CSV (Computer System Validation) and must follow some main principles and regulations according to the GCP E6 R2 (section 4.9.0), according to the Data protection regulation of the country (eg. GDPR, HIIPA, etc) and according the CFR 20 part 11 released by the FDA that gives the requirements of a system that has to be used to collect Electronic records of Medical records equivalent with paper records.