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Type:
Task
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Resolution: Unresolved
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Priority:
Major
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Affects Version/s: CSD-PR-1 Comments
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Component/s: Specification
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None
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Environment:
Eldin Rammell <[email protected]>
The phrase “clinical trial content” is used incorrectly. This specification is limited to the content of the trial master file and not ALL clinical trial content. Please replace with “clinical trial master file content”....
Please change “clinical trial domain” in paragraph 3 of 2.1 to “clinical trial master file domain”; this specification is limited in scope to the trial master file only.