An EDC (electronic data capture) system – also known as eCRF (electronic case report form) – is an extremely important software tool in clinical trials. Clinical research relies on accurate data. To gather, clean, and analyze the data generated in clinical studies, EDC solutions are used. Here, we talk about the users of electronic data capture systems.
Clinical Data Users of Electronic Data Capture “User Groups”
There are three user groups in the EDC system: primary users, secondary users, and super users. To access the system, the primary and super users are required to create user accounts, whereas the secondary users are not. The system uses the university-wide federated access control service (referred to as the Shibboleth single sign-on authentication service) for authenticating primary and super users. Thus, those users don’t need to maintain separate accounts for EDC systems.
The super users have two roles: honest broker and system administrator. While the honest broker handles the data requests from several research teams, the system administrator manages the RDR and EDC systems. An honest broker is a person who gathers and offers PHI data to research investigators in an IRB-approved manner. The primary users consist of the research team members like data analysts, data entry personnel, scientists, study coordinators, coinvestigators, co-principal investigators, and principal investigators. The project owners have access to the project management tools like the CRF design module and project setup. The data analysts have the user rights to export de-identified data for data analysis, and the data entry personnel have the user rights to modify or create records.
Secondary Users of Clinical data EDC systems
The secondary users are study participants, comprising survey participants and study subjects. Study subjects may use the system to sign electronic consents. The data entry personnel enter any data gathered from the study subjects into the research database. Laboratory results can either be imported electronically from the EMR (Electronic Medical Record) system or entered into the research database by data entry personnel. If a project has survey instruments, participants may record their responses via a public URL or through personalized URLs.
ClinicalPURSUIT’s EDC software for clinical trials offers all the features required for successful clinical trials
From intelligent electronic data capture to rapid study development, ClinicalPURSUIT’s EDC clinical trial software is different from typical solutions due to the advanced features it provides that ensure successful clinical trials.
Give us a call now for more information on our clinical electronic data capture software!