Module 18 2021

2/9/2021

Data collection: comprehensive searches

• Search strategy can introduce bias through missed data if not sufficiently: • Systematic • Sensitive • Specific

If search results are incomplete, data may be skewed (either positively or negatively) and failure modes or adverse events missed.

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Copyright © 2020 BSI. All rights reserved

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Data collection: comprehensive searches

• Search strategy can introduce bias through missed data if not sufficiently: • Systematic • Sensitive • Specific Manufacturers should provide their complete literature search protocol, to allow an assessment of the robustness of methods used.

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Copyright © 2020 BSI. All rights reserved

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