electronic Case Report Forms (eCRF)

In the year 1996 Aix Scientifics^® was founded to perform clinical research with help of Internet technology in a time and effort saving manner. Since more than ten years nearly all clinical studies were performed Internet-based and multi-lingual.

Electronic Case Report Forms (eCRF) replaced the conventional printed-paper sheets. As designed using plain HTML, CSS and JavaScript the eCRF in available globally with all modern Internet browsers independent of particular computer platforms. There is no need for installation of plug-ins, Java, or other special software. No 'cookies' or frames are used. For authorised users, this allows the access from any web-connected place worldwide at any time.

The system is scalable and adaptable to study-specific technical requirements, as well as adjustable to specific visual designs.

The user logs in with a personal username and password. The communication is always at least 128-bit SSL-encrypted. Instead of using paper forms, the investigator or a study nurse interactively fills in the electronic forms. The data are checked automatically for plausibility and completeness during data entry. Reactive alerts and helps assure correct completion. The system warns about extreme values or rejects data if the values are medically impossible. Feed back pages guide the user interactively through the forms. However, all pages can be saved incomplete or with questionable data as draft. After final checks they are finalised by the investigator.

Electronic Case Report Forms (eCRF) shorten the way of the data from the clinical centre to Aix Scientifics^®, where they are stored and evaluated. Instead of filling in paper forms and later entering the data in the database, the data are remotely entered into the database, while being been checked extensively. Therefore, a lot of misunderstanding, lacking or incorrect data can be avoided. This shortens the time from the source of the data to the validated storage in the database by weeks or months. Shortly after completion of the last study case the database can be locked and the evaluation will be done immediately. Finally, the eCRF reduces the efforts necessary to perform a clinical study and correct the failures. This is true for the clinic as well as for monitoring.

The system traces each modification of the data in the database, to document with day and time who did enter or correct the data. In case of changes the original data remain unaffected.

Real Time Feedback is a major attainment of the Internet-based data collection. Due to the data being stored immediately in a database there is no delay for getting information about the progress of the study or the situation regarding adverse events. While scientific results should be drawn only from the final collection of all study data, status information can seriously improve trial management.

We're constantly improving the usability of the system based on the user feedback we get from the participants in our studies.