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Procedural issues A system shall be established to enable cross-referencing of CRFs and C...

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Cover page or login screen (1) Name of sponsor or sponsor logo. (2) Clinical investigation...

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Format of informed consent form for Subjects participating in a clinical investigation Ce...

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Procedural issues A system shall be established to enable cross-referencing of CRFs and CI...

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Publication policy (a) Statement indicating whether the results of the clinical investiga...

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Figure 13: File Number for 24Hour Reporting 2.2 SAE Reporting (14th Day due Analysis Repor...

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User Manual Page | 16 To report serious adverse events (SAE), there are three types of for...

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