PROs and Data Collection: Electronic CRFs

3. Electronic CRFs

Electronic CRFs are increasingly popular but are much more complicated to produce and need to adhere to strict regulations in Europe and the US:

Europe: ICH GCP E-6, Section 5.5.3.
US: FDA - 21CFR Part 11 and Guidance for Industry - Computerised Systems Used in Clinical Trials.

The computer systems and the eCRF software must be validated and it must be possible to see every correction that has been made to the data entered (audit trail). It must be ensured that only authorised persons have access to the programme and data. A back-up of the data has to happen regularly and automatically.

eCRFs in a study require that all investigator sites have sufficient and reliable access to computers and Internet. Intensive training of the site staff in using the eCRF is required, often also supported by a help-desk.

Advantages

The eCRF has automatic checks to reduce data entry errors and gives a warning if an error is made when entering the data (e.g. body temperature 370.6°C instead of 37.6°C). This also helps to avoid violation of protocol requirements.
The entered data is immediately available to the sponsor who can see whether the site has entered data correctly and when this took place.
Questions for further information on the entered data can be raised faster than in a paper-based system.

Disadvantages

Potential technical problems related to eCRFs or to the study site’s technical infrastructure.
Study staff may need specific training or be capable of using a particular electronic system.