The Confidential Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) are basically the same. They denote an agreement between two or more parties to protect the exchange of confidential information
A Clinical Trial Agreement (CTA), Clinical Study Agreement or Clinical Research Agreement are all names for an agreement or contract between the university and another party relating to the conduct of a clinical trial or study.
A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
An Investigational Device Exemption (IDE) allows an investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and Drug Administration (FDA).
UB's Clinical Research Center (CRC) is a fully equipped center offering a wide range of services for investigators and staff who conduct clinical studies. The Center is located at 875 Ellicott Street, Buffalo, NY 14201.
If you require access to Kaleida Health (KH) electronic medical records or will be conducting study related procedures within KH, you must complete an appointment package and submit it to Kaleida's Office of Research and Sponsored Projects.