check the documentation in the SMQ Introductory Guide to understand the purpose and definition of the SMQ. The user may also wish to review the term contents of the SMQ. Following application of the selected SMQ on coded data, search results (i.e., retrieved data) should then be evaluated against the question originally posed. The search output alone may not be sufficient for data assessment (e.g., frequency of a condition). Define and document criteria for case evaluation. Generally, more cases/events will be retrieved than will eventually be subjected to analysis due to This is a more significant consideration for searches but in principle “noise”. “broad” also applies to searches (see Section 4.10.1). “narrow” Clinical trials SMQs may be applied in the clinical trial setting especially for aggregate data where – – the safety profile has yet to be fully established. In this instance, most (if not all) available SMQs may be used, possibly on a routine basis. Alternatively, a user can apply an SMQ (or SMQs) that relates to a previously identified area of interest (e.g., from pre-clinical data or class effect) for further evaluation. Example Targeted Safety Study When developing a data analysis plan for a targeted safety study, consider using the narrow terms of an SMQ to aggregate events of interest. Post-marketing Focused searches A specific SMQ or a selection of SMQs may be used to retrieve relevant cases for subsequent medical review. Example Emerging Safety Signal A company suspects an emerging signal of pancreatitis for a new HIV product. SMQ Acute pancreatitis can be applied to the data. Signal detection The entire set of SMQs may be used on the database for signal detection. The user may wish to use the narrow terms or more specific levels of hierarchical SMQs (i.e., a SMQ) to minimise dilution of the signal. Single case alert SMQs may be used to create a (e.g., an automated notification system) to alert “watch list” the user of incoming cases needing urgent review.
check the documentation in the SMQ Introductory Guide to understand the purpose and definition of the SMQ. The user may also wish to review the term contents of the SMQ. Following application of the selected SMQ on coded data, search results (i.e., retrieved data) should then be evaluated against the question originally posed. The search output alone may not be sufficient for data assessment (e.g., frequency of a condition). Define and document criteria for case evaluation. Generally, more cases/events will be retrieved than will eventually be subjected to analysis due to “noise”. This is a more significant consideration for “broad” searches but in principle also applies to “narrow” searches (see Section 4.10.1). Clinical trials SMQs may be applied in the clinical trial setting – especially for aggregate data – where the safety profile has yet to be fully established. In this instance, most (if not all) available SMQs may be used, possibly on a routine basis. Alternatively, a user can apply an SMQ (or SMQs) that relates to a previously identified area of interest (e.g., from pre-clinical data or class effect) for further evaluation. Example Targeted Safety Study When developing a data analysis plan for a targeted safety study, consider using the narrow terms of an SMQ to aggregate events of interest. Post-marketing Focused searches A specific SMQ or a selection of SMQs may be used to retrieve relevant cases for subsequent medical review. Example Emerging Safety Signal A company suspects an emerging signal of pancreatitis for a new HIV product. SMQ Acute pancreatitis can be applied to the data. Signal detection The entire set of SMQs may be used on the database for signal detection. The user may wish to use the narrow terms or more specific levels of hierarchical SMQs (i.e., a SMQ) to minimise dilution of the signal. Single case alert SMQs may be used to create a “watch list” (e.g., an automated notification system) to alert the user of incoming cases needing urgent review.
9610-1800_datretptc_r3_9_mar2015_0.docx