Serious Adverse Event: Defined as events that are fatal, life-threatening, permanently disabling, or require inpatient hospitalization or prolong an ongoing hospitalization. Congenital anomalies/birth defects in the offspring of a subject, cancers, or overdoses are also considered serious events.
SOP: Standard Operating Procedures – Detailed, written procedures for the uniform performance of a function. For example, IRB must have and R&D Committees should probably have written SOPs. These must be consistent with the “Common Rule” and federal regulations and policies pertaining to research compliance and protection of human subjects. (Federal regulations tell “what” to do, but not “how” to do it. individual institutions SOP outline the “how” to do research at that institution.)
Subjects (Human): See definition of Human Subjects.
Suspended Protocols: Suspension of IRB approval. An action taken by the IRB to temporarily or permanently withdraw approval for some or all research activities short of permanently withdrawing approval for all research activities.