Requirements for Evidence-Based Templates in Electronic Case Report Forms

Abstract

Background: Electronic case report forms (eCRF) play a key role in medical studies and medical data registries (MDR) for clinical research. The creation of suitable eCRFs is a challenging and yet a very individual task.

Objectives: We plan to create evidence-based templates for eCRFs which are aligned with existing studies or MDRs.

Methods: In this paper we investigated existing standards for eCRFs, defined uses cases and derived requirements needed to identify and annotate data items and pertinent information within study protocols, literature or patient cases.

Results: In order to establish evidence-based eCRF templates based on annotated text documents, a standard-based, hierarchical structure with linkage to existing data repositories needs to be modeled. Standards like ISO/IEC 11179 provide a necessary base, which needs to be extended with proper linking functions.

Conclusion: Linking evidence-based sources with eCRFs allows creating templates, which could be used to define eCRFs for new clinical studies or even compare studies among them. As a next step, the derived requirements from this paper will be used to establish an ontology-based structure for annotating existing text-documents with eCRF data elements.