EHR4CR local workbench
Journal of Clinical Bioinformatics volume 5, Article number: S12 (2015)
Tool, recruitment process, multi-centric clinical trials.
This tool supports administering and monitoring the recruitment process for multi-centric trials within a single clinical centre. It works together with the EHR4CR central workbench and allows receiving, accepting or rejecting invitations to participate in clinical trials (Figure 1). Local users can be assigned to clinical trials under a given role and engaged as such in different steps of the local subject identification and recruitment process. The tool also supports automatic fetching of a list of potential candidate patients for recruitment from a local clinical data warehouse based on formalized eligibility criteria included in the trial metadata. Once identified, potential candidate patients and their subsequent recruitment status can be managed and monitored (ranging from the status of potential candidate over confirmed candidate, patient in screening, patient has consented, etc.). Role-based re-identification of pseudonymised patient records avoids that the patient’s identity is exposed before the patient has been contacted by a treating physician and before the patient has agreed to participate in the recruitment process. The tool is a workflow-driven system that supports task assignment to end-users and triggering automatic periodic submissions of the clinical site’s recruitment numbers to the study sponsor or CRO.
Status of development
Under evaluation by the EHR4CR pilot sites (November 2014).
Clinical sites (data relationship managers, (principal) investigators, study nurses, treating physicians).