Welcome back to the GCP Mindset channel. As you may know from our previous videos, the essential documents of each clinical study are the study protocol, the investigator's brochure, and the case report form. Today, we talk about the electronic case report form (eCRF). Originally, all case report forms were made on paper, but recently there is a changing trend to clinical studies using an electronic case report form. The research-based industry has increasingly begun to use these eCRFs. The associated process of electronic acquisition of data at the trial site is referred to as remote data entry or electronic data capture. The use of paper CRF causes the creation of numerous queries by the data management due to illegible data. By using eCRFs, the bad handwriting of the person filling in the eCRF is not applicable as an error source because the legibility of the data is ensured at all times. Thus, fewer queries are created. The reduced paper consumption should also be seen from economic and ecological viewpoints. Quicker data transmission is possible because paper files no longer have to be transported. Monitoring can be planned and prepared by the monitor based on a review of data from a distance. A direct data check for plausibility is possible, as well as work operations such as SAE reporting, which can be considerably facilitated by automated processes. Furthermore, numerous plausibility checks can be programmed in an eCRF so that many incorrect entries, for example entering the current date as the date of birth, are not possible at all. This enables remote monitoring in which the data entered is checked for correctness and completeness, while the focus of monitoring in the study center is on source data verification (SDV), for example the comparison between the database entries and the source documents....
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