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Glossary

Justification Table

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In relation to Policy 70, to be completed by the Applicant to justify the proposed redaction of CCI.

Other glossary definitions

G

Good Clinical Practice (GCP)

As defined in ICH E6 “A standard for the design, conduct, performance, monitoring, auditing, recording,…

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C

Clinical Evaluation Report (CER)

Required under the new MEDDEV 2.7.1 Rev. 3 guidelines. Document containing information and results generated…

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