OnCore eCRF Development
The creation and design of electronic case report forms (eCRFs) is a multi-faceted process that requires thorough coordination and communication to ensure that adequate data is collected during studies. The UVA OnCore developer is responsible for assisting oncology researchers in creating and maintaining eCRFs that are built in the OnCore system. This system is generally only used for studies that focus on oncology patients and that may require oversight by the Cancer Center Data Saftey and Monitoring Committee (DSMC). These forms can be saved into a library and used across multiple protocols. This eliminates the need to recreate commonly used forms and promotes data standards. Other eCRF systems are also available at UVA for non-oncology studies, including REDCap and MUSIC. We can work with you to determine the best tool for your project.
Note: The system is NOT yet 21 CFR Part 11 compliant. This means that it should NOT be used IF:
- your study is FDA regulated AND the data will be submitted as part of a marketing approval application OR
- your study is FDA regulated AND the study involves eConsent
What are OnCore's eCRF features and capabilities?
It has the following capabilities: Validated questionnaires, treatment summaries, adverse event capture & follow up, lab results, prior treatment summaries, physician exams, medical history, saving form versions, retiring forms, and form specific permissions.
Your OnCore eCRF Data
Your OnCore eCRF project data is kept secure and private. OnCore eCRF can remove identifiers from a dataset prior to exporting for analysis to create a limited dataset or a safe harbor data set- contact oncoresupport@uvahealth.org for more details. By removing the 18 pieces of information considered PHI, Protected Health Information, for the purposes of HIPAA compliance, you are generating a safe harbor data set; you can then share this data with collaborators more easily.
Your data storage and collection is guaranteed the following:
- Data stored on a secure server
- Database access requires user authentication with password
- Data access based on an individual's role on a project
- UVA IRB and UVA Information Security (Information Policy Office) approved for collection and storage of PHI including surveys