eCRF

The case report form, commonly known as “CRF” or its electronic equivalent “eCRF” (electronic case report form), is a study document following certain rules described in the clinical investigation plan which is used for storage of clinical data. As errors in the case report form (e.g. the absence of identification fields) can lead to serious problems (e.g. lack of assignability in longitudinal studies), the structure of the CRF / eCRF is crucial for conducting clinical trials.

Case report forms (and eCRFs) are characterized by a well-designed and comprehensible structure. They usually include all relevant data fields (e.g. demographic data, questionnaires, laboratory parameters) and – in order to save time and resources – should also address biometric requirements (e.g. data structure) of a clinical trial. While case report forms used to be predominantly paper-based in the past, there is a trend towards direct documentation in electronic form (eCRF) nowadays.

CCMD provides its customers with a validated and certified eCRF system called Studymate© to easily and intuitively collect patient data. Studymate© has been validated in accordance to local and international regulatory requirements (ICH-GCP E6 (R1), FDA 21CFR Part 11, Guidance for Industry – Computerized Systems used in Clinical Investigations, GAMP5) and offers many advantages compared to common paper-based case report forms.

Studymate© is completely web-based which allows the user to document patient data without prior software installation. The sponsor can review the documentation at any time and as data entries are automatically checked for plausibility and completeness, the number of queries can be reduced considerably.

For inquiries to the study center, the eCRF also serves as a communication tool (i.e. requests can be asked, answered and closed within the system. Furthermore, data changes are stored in an internal audit trail and can be traced at any time. A reporting system for adverse events, serious adverse events, device deficiency and pregnancy has also been implemented in the eCRF system Studymate©. The automatically forward function – which sends information about observed events directly to authorities and other predefined parties – renders a paper-based reporting obsolete.

In summary, Studymate© gives you the ability to increase the quality and traceability of your study, while saving time and money (e.g. by avoiding time-consuming data post-processing).