Paper Case Report Forms (CRFs)Paper CRFs are designed for handwritten data entry. They are cheap to produce and can easily be copied and faxed. Neither computer access nor passwords are required, furthermore they are not stationary and therefore more flexible for use. In case of amendments during the conduct of the study, these can be implemented relatively easy and quickly. On the other side, a lack of automated support and checks, as well as the need for an additional data transfer create possible sources of errors and therefore represent some of the disadvantages of a Paper CRF.
Electronic Case Report Forms (eCRFs)The creation of an eCRFs is more complicated and complex. It must be validated and every data correction must be traceable (audit trail). It must be ensured that only authorized personal has access to the program and that regular automatic data backups are carried out to meet the following requirements:
- ICH GCP E-6
- FDA-21CFR Part 11
- Guidance for Industry - Computerized Systems used in Clinical Investigations
In order to use an eCRF in a study, access to computers and the Internet is mandatory. In addition, study staff has to be trained on the eCRF. Furthermore, also phone support is often necessary.
The eCRF ("Marvin", XClinical) used by our company fulfils all requirements mentioned above. In addition, direct data collection (DDC) and patient-reported outcomes (PROs) are also possible. DDC refers to direct data import (e.g. laboratory / ECG data, electronic patient questionnaires / diaries) via electronic devices. PRO means that data is recorded directly by the patient on paper or in an electronic system. This includes all types of questionnaires and diaries.
No matter which kind of data collection is required by you, we are happy to create the right system for your project and therefore the basis for high data quality.
Both CRF and eCRF must be easy to handle and understand for several parties. Our wide-ranging service portfolio allows our experienced staff to take all possible considerations into account when creating your data collection system.