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Type:
Bug
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Status: New
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Priority:
Major
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Resolution: Unresolved
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Affects Version/s: Electronic Trial Master File (eTMF) Specification Version 1.0
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Fix Version/s: None
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Component/s: Public reviews
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Labels:None
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Environment:
Normative
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Proposal:
Clearly 6.2 Electronic and Digital Signatures as well as 6.3 Business Process Model are non-normative but not marked as such. The TC has not defined any normative requirements for either area and so cannot be writing normative text about either one.