Systems, Platforms & Infrastructure
Clinical Studies
YCMI services span the life cycle of the protocol from initial protocol review to final data analysis:
- Pre CRF design: Assistance with electronic implementation of the protocol. Assessment of what would be involved in electronically setting up the different aspects of data capture, for example, study calendar, study sites, users etc.
- CRF design: In conjunction with the PI, YCAS and the study coordinator, YCMI assists in defining the data elements involved in the protocol including data validation and integrity. This also involves grouping them into CRFs convenient for data capture.
- Data Monitoring: In collaboration with the PI and the study coordinator, YCMI generates reports that can be run on a regular basis to facilitate data monitoring.
- Data Retrieval: Assistance to study personnel in retrieval of data as and when required and also generation of reports for IRB submission.
Informatics Infrastructure
YCCI is providing input to the School of Medicine and Yale New-Haven Hospital on building and integrating a strong informatics infrastructure for patient care and clinical research. Its components include:
- Epic, enterprise-wide Electronic Health Record system (EHR)
- OnCore, enterprise-wide Clinical Trials Management System (CTMS)
- Clinical Data Repository
- Informatics support for genomics and proteomics
- Yale Biomedical Supercomputer
- Yale is harnessing the power of ever-increasing amounts of digital health data via Epic, an enterprise-wide electronic health record (EHR) that contains millions of unique patient records.
OnCore, Yale's new Clinical Trials Management System (CTMS), seamlessly integrates all of the components of research activity across the research enterprise.
- Research Electronic Data Capture (REDCap) is a secure web application for building and managing online surveys and databases.
Forte eRegulatory Management System (eReg) is an electronic regulatory binder maintenance system used to collect and manage protocol, staff, and institution documentation.
- Healthcare is increasingly moving toward patient-centered care and patient-centered research is the next logical step, but investigators face several challenges.
Sponsor monitors are allowed to access the Yale enterprise-wide Electronic Health Record (EHR) for source data verification, both on-site and remotely.
You should carefully consider all your study needs before deciding on a data system.
Administrative innovation has been a hallmark of the YCCI, driven by continuous process improvement and ongoing self-evaluation.