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The Context attribute is optional and indicates the intended usage of the ODM document. Context may be set to Archive, Submission, or Exchange. Context=Archive indicates that the file is intended is intended to meet the requirements of an electronic record as defined in 21 CFR 11. FileType must be Transactional when Context is Archive. Context=Submission indciates that the file is intended to be used as part of a regulatory submission. Context=DataExchange Exchange indicates that the file was generated to be imported into an ODM compliant system. |
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- The current file must be Transactional.
- If the current file is one of a collection, all other files in the collection must be both Context=Archive and FileType=Transactional.
- The set of transactions must be both complete and non-redundant within the file or collection of files. In particular each file must contain:
- no transactions that have an audit date of prior to the AsOfDateTime of its PriorFile (if any),
- all transactions up to its AsOfDateTime. (For Granularity=All, this means all transactions in the study. See Granularity for the meaning of "all" for other Granularity settings),
- all AuditRecord and Signature information available in the source database, and
- no Upsert transactions.
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