Minimum Criteria. The minimum criteria required for an ADE report, which must include the following: • Name of the drug, • Event or outcome, • Patient identifier (any one or more of name, initials or clinical investigation number, age, sex ore weight), and • Identifiable source of the report.
Appears in 2 contracts
Sources: Development and Supply Agreement (Sagent Holding Co.), Development and Supply Agreement (Sagent Holding Co.)