Model Documentation

Class: ReferenceDocument

The ReferenceDocument class is used to identify the documents that are referenced within the reporting event. Each reference document has a name and location, and is assigned an id value. If needed, the optional description and label attributes may be used to record, respectively, a detailed description and/or a short description of the reference document.

ER Diagram: ReferenceDocument

The ARS ReferenceDocument class corresponds with the Define-XML def:leaf element that is referenced in the ARM for Define-XML specification:

ARS ReferenceDocument AttributesCorresponding Define-XML def:leaf Attribute/Element

id

ID attribute
locationxlink:href attribute
namedef:title element
descriptionN/A
labelN/A

Reference documents may contain either documentation (e.g., specifications for analyses, representations of outputs) or programming code.

Example

In this example reporting event, there are 4 reference documents:

Lines 2-5:

Show the "Statistical Analysis Plan", which has been assigned the identifier value "CDISCPILOT01_SAP" and a label of "SAP". The file for this document (sap.pdf) is located in the same folder as the reporting event file.

Lines 6-9:

Show the "Clinical Study Report", which has been assigned the identifier value "CDISCPILOT01_CSR" and a label of "CSR". The file for this document (csr-cdiscpilot01.pdf) is located in the "reports" sub-folder of the folder that contains the reporting event file.

Lines 10-12:

Show the "AE Summary Table Shell" program file, which has been assigned the identifier value "AE_Summary_Table_Shell". The file for this document (AE_Summary_Table_Shell.pdf) is located in the same folder as the reporting event file.

Lines 13-16:

Show the "at14-5-01.sas" program file, which has been assigned the identifier value "at14-5-01_sas" and a description of "Program for generation of table 14.5.01". The file for this document (at14-5-01.sas) is located in the "programs" sub-folder of the folder that contains the reporting event file.

YAML Example
referenceDocuments:
- id: CDISCPILOT01_SAP
  location: ./sap.pdf
  name: Statistical Analysis Plan
  label: SAP
- id: CDISCPILOT01_CSR
  location: ./reports/csr-cdiscpilot01.pdf
  name: Clinical Study Report
  label: CSR
- id: AE_Summary_Table_Shell
  location: ./AE_Summary_Table_Shell.pdf
  name: AE Summary Table Shell  
- id: at14-5-01_sas
  location: ./programs/at14-5-01.sas
  name: at14-5-01.sas
  description: Program for generation of table 14.5.01

These reference documents could be represented in tabular form as:

$titleHtml
idlocationnamedescriptionlabel
CDISCPILOT01_SAP./sap.pdfStatistical Analysis Plan
SAP
CDISCPILOT01_CSR./reports/csr-cdiscpilot01.pdfClinical Study Report
CSR
AE_Summary_Table_Shell./AE_Summary_Table_Shell.pdfAE Summary Table Shell

at14-5-01_sas./programs/at14-5-01.sasat14-5-01.sasProgram for generation of table 14.5.01
$warningHtml

Once an identifier value has been assigned for a reference document, references to the document as a whole, or to specific parts of the document, may be made using the DocumentReference class.

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