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    1. Derived from actual observation of the administration of drug by the investigator
    2. Derived from automated dispensing device that records administrations
    3. Derived from subject recall
    4. Derived from product accountability data
    5. Derived from the protocol. When a study is still masked and protocol-specified study treatment doses cannot yet be reflected in the protocol-specified unit due to blinding requirements, then the EX domain is not expected to be populated.


      

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EX/EC Example Archived
EX/EC Example Archived

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EX/EC Example 2
EX/EC Example 2

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EX/EC Example 3
EX/EC Example 3

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EX/EC Example 4
EX/EC Example 4