This policy applies to activities that involve the secondary analysis of data (such as medical records, student records, data collected from previous studies, audio/video recordings, etc.) or ...

The Regulatory Citation and How It Applies: Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least ...

This secondary data review template is an indicative template which can be customized based on the operational needs that are clarified in the assessment objectives and defined more clearly in the ...

Useful aspects of submitted secondary pharmacology data. Detailed aspects of secondary pharmacology data that are considered to be useful during regulatory safety assessments are summarized in Table 1 ...