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- documentation of the analysis as specified in the SAP and/or protocol,
- output displays in a clinical study report or integrated summary,
- program files containing programming code for specific analysis methods, for analyses, or for outputs.
| Excerpt Include | ||||
|---|---|---|---|---|
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A document reference must include the identifier of the reference document (as specified in the referenceDocumentId attribute) to indicate which document is being referenced. If needed, the document reference may also include one or more "page references" (each specified in the pageRefs attribute) to indicate the relevant page or pages within the reference document. A document reference that does not include any page references is areference a reference to the document as a whole. In general, there are two types of document reference:
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ARS PageRef Attributes | Corresponding Define-XML def:PDFPageRef Attribute |
|---|---|
refType | Type |
| label | Title |
| pageNames | PageRefs |
| pageNumbersPageRefs | |
| firstPage | FirstPage |
| lastPage | LastPage |
...