Q: What are the CSEC and the IRB?
A: Beginning in August 2013, the Institutional Review Board (IRB) implemented a new review process. Prior to submission of a scientific protocol to the IRB, the Clinical Study Evaluation Committee (CSEC) must review the document for approval. After approval by the CSEC, the scientific protocol may be sent to the IRB for final approval. For more information regarding the IRB please visit this website.
This process is essential to ensure research studies are high quality, high impact, and maintain patient safety and confidentiality. Research studies may not be conducted in this institution without the appropriate approvals from these governing bodies.
Q: How can I use data from the RDR?
A: An internal process has been created to manage requests for data from the RDR. In order for a Department of Anesthesiology researcher to gain access to data from the RDR, the researcher must first follow department protocol and vet their research question through the Director of Clinical Research. Once approved, the researcher must develop a scientific protocol and submit it for review to the Clinical Study Evaluation Committee (CSEC) and the Institutional Review Board (IRB). Once approval is gained from these governing bodies, the governance committee in the Department of Anesthesiology will review study documents and approve the transfer of data. Questions related to this process should be sent to CPO staff or the Clinical Research Team.
Q: What local data sources are available to Weill Cornell Medical College researchers?
A: The Department of Anesthesiology, in partnership with the Architecture for Research Computing in Health (ARCH) of the Department of Research Computing has partnered to create a Research Data Repository (RDR) to house pre-, intra-, and post-operative data in a single location. This RDR will allow for easier access to various pieces of information (demographic, clinical, provider, and outcomes information) necessary to answer clinical and outcome based hypotheses.
Q: What are these data sources and how do I gain access to them?
A: Each database contains different information and the data source needs to be chosen carefully to best answer study objectives. In order to utilize the data each database has unique requirements. Below are specific sections for each data source to explain the database and the requirements.
Q: What databases does the CPO maintain that may be used for research?
A: The CPO has many national and local databases available for use with collaborators, including the State Inpatient Database (SID), Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality; National Inpatient Sample (NIS), Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality; the Multicenter Perioperative Outcomes Group (MPOG); the National Anesthesia Clinical Outcomes Registry (NACOR), developed and maintained by the Anesthesia Quality Institute (AQI); and the American College of Surgeons National Surgical Quality Improvement Program; and local data.