Electronic or paper filing system which must contains all study documents and at least essential documents as described in ICH E6.
Other glossary definitions
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Integrated summary of Safety (ISS)
Comprehensive integrated analysis of the effectiveness of a study drug, recommended to be submitted to…
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I
In Vitro Diagnostic Medical Device (IVDMD)
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,…
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