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Glossary

Anonymization

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The process of rendering data into a form which does not identify individuals and where identification is not likely to take place, for example to comply with the requirements of Policy 70.

Other glossary definitions

I

Important Missing Information

Critical gaps in knowledge for specific safety issues or populations that use the marketed product.

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N

Non-substantial Amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does…

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