Module 3 2019

Enhancing your submission - data

• Follow the guidelines – or justify fully where you do not. Should you seek scientific advice rather than “take the risk”?

• Present data in a logical manner – justify key decisions with data. Present key data within the correct section; avoid annexing multiple reports.

Own your data!

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• Acknowledge missing or inconsistent data and out of specification results.

• Evaluate data that is out of trend or has an adverse trend. Justify acceptability (remember the “positivity sandwich”!)

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