Glossary

A statistical analysis plan (SAP) is a document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol.

A study site is the place, where the study specific operations are carried out. Thus, a study site can be a hospital or medical practice, where patients or healthy volunteers are treated according to the study protocol.

A study nurse, also called study assistant or study coordinator, is a member of the site staff acting as a liaison between site and sponsor during a clinical trial. A study nurse is supportive of the investigator in all administrative functions related to a clinical trial, including enrolling trial participants, the collection and documentation of study-related data and reviewing data and records prior to and during a monitor´s visit.

A serious adverse event (SAE) is any untoward medical occurrence in a clinical trial that results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect, or requires intervention to prevent permanent impairment or damage.