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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

E

Expedited Criteria

Criteria that should be fulfilled for expedited reporting. The four minimum information required for expedited…

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S

Substantial Amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that…

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