Invalid Case definition
Invalid Case. An incomplete case report that does not contain the minimum criteria, i.e. an identifiable reporter (source), an identifiable patient, a suspected medicinal product(s) and an AE/ADR, for reporting as defined by applicable law, but at a minimum it contains a suspected medicinal product(s) and a suspected event. Such reports are entered in the safety database as potential cases of value for signal detection purposes. Periodic Safety Update Report (PSUR): a post-marketing periodic aggregate report containing the records referred to in ICH E2C (R2), Article 104 of Council Directive 2001/83/EC, Article 24(3) of Regulation (EC) No 726/2004, European Medicines Agency EMA/816292/2011 Guideline on Good Pharmacovigilance Practices (GVP) Module VII –Periodic Safety Update Report and similar reports required under applicable law in other territories. Safety Report covered by the Agreement is those arising from use of the Product(s) within the terms of the marketing and those arising from the use outside the terms of the marketing authorization.
Invalid Case. An incomplete case report that does not contain the minimum criteria for reporting as defined by applicable law (i.e. an identifiable reporter, identifiable subject/patient, suspect medicinal Product(s) and event), but at a minimum it contains a suspect medicinal Product(s) and a suspect event. Such reports are entered in the safety database as potential cases of value for signal detection purposes.
Invalid Case an incomplete case report that does not contain the minimum four data elements for reporting as defined by applicable law (i.e. an identifiable reporter, identifiable subject/patient, suspected medicinal Product(s) and event), but at a minimum it contains a suspected medicinal Product(s) and a suspected event. Such reports are entered in the safety database as potential cases of value for signal detection purposes. Non-serious Adverse Drug Reactions: non-serious ADRs are ADRs that do not meet the definition of a Serious Adverse Drug Reaction.