Valid Case Sample Clauses

Valid Case. A Valid Case is one that includes, at a minimum, a suspect drug, an event, an identifiable reporting source, and an identifiable subject. For example: • A report of a patient experiencing unspecified injury or irreparable damage does not meet the criterion for an event until more specific information about the event can be determined. • An email address alone does not constitute a valid reporting source. • Secondary or hearsay reporting sources, e.g., 'I heard that someone else had a case of' are only considered identifiable if they concern a health care professional with a known name or location. • An identifiable subject requires, at least, gender, age, age category (elderly), date of birth, initials, social security, medical record or other identifying number. Regardless of what information Prometheus is able to obtain, it is imperative that Prometheus provides all of the reporter's details to enable AZLP to obtain the necessary additional details. Prometheus should report events regardless of whether the events are in the prescribing label.

Valid Case. A case which includes the minimum information required for all reporting purposes, consisting of an identifiable patient, the name of the suspect medicinal product, an identifiable reporting source and an event or outcome that can be identified. However, if none of the above is provided, yet the information in the report suggests that the reporter is identifying an individual subject, judgment for accepting this as an identifiable subject is based on the credibility of the source and nature of the reported event. A report, describing for instance ‘several patients,’ does not meet the criterion for an identifiable subject.

Valid Case only reports of Serious Adverse Drug Reactions that include the minimum four data elements are considered valid and required to be reported. *NOTE: capitalised terms that are not defined in the SDEA shall take their meaning from the Distribution Agreement.