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
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