Case Report Form Development

The physicians and staff in the Cardiovascular Core Labs are available to support the creation of study-specific case report forms(CFRs). CRFs for the clinical sites are designed to help improve compliance with the acquisition protocol. They often involve a "checklist"’ and on-site measurements of key fields. The Core Lab will also develop a data transfer (or Core Lab) 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 eCRF'’s that can be housed within the Core Lab or web-based. Electronic CRFs utilize drop-down menus and "‘gray-out"’ functions to ensure complete and accurate data collection. Electronic-based CRFs 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.