Case Report Form Development
The physicians and staff in the St. Francis Hospital Core Labs are available to support the creation of study-specific case report forms (CRF). These CRFs for the clinical sites are designed to improve compliance with the acquisition protocol. They often involve a “checklist” and on-site measurements of key fields. The Core Lab will also create a data transfer case report form with all the analysis fields performed. This will be developed, in collaboration with the sponsor, to ensure all data that relates to study primary and secondary endpoints that are image-related, are appropriately captured.
The Cardiovascular Core Labs can use either electronic or paper CRFs. The lab has partnered with commercial vendors to implement electronic CRFs or eCRFs, which can be housed within the Core Lab or web-based. eCRFs utilize drop-down menus and “gray-out” functions to ensure complete and accurate data collection. eCRFs may be customized to meet the sponsor’s needs and have many advantages such as reduction of data queries, streamlined data transmission and implementation of real-time, data quality assurance measures.