Module 15 2022

19/05/2022

Identify the clinical data

Literature searches:

● Identify all relevant favourable and unfavourable data ● Several searches /search approaches ● A documented search protocol and report required ● Sources of Literature Appendix A4 ● Literature search Appendix A5

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

27

Identify the clinical data

Key elements of the search protocol:

● Background ● Objectives ● Methods

– Data sources with justification – Search terms and any limits – Inclusion/exclusion criteria – Plans to address: data integrity, duplicates, appraisal & Analysis of data

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

28

14