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StageDescription
CreateA document needs to be well designed from the point of creation using the name, category, confidentiality classification. 
DistributeA document is available for employees and/or the general public according to the confidentiality classification.
UseA document has been distributed internally, and can generate business decisions, further actions, or serve other purposes. (external use is outside the scope of this policy)
MaintainWhile a document is in active use, it is necessary that the content is maintained, accurate and available. If changes in the document need to be done, those changes need to be documented within the document. 
Dispose / ArchiveThis will occur with a document that is accessed less frequently or has reached its assigned retention periods. During this stage the document could be destructed or transfer to a file until a retention period is reach. 

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  • Outlook
  • Confluence Wiki
  • SharePoint / OneDrive
  • Azure DevOps Wiki
  • GitHub Wiki

Documents will have a an explicit name, category, and confidentiality.

Name - todo

Category - todo

Confidentiatliy Confidentiality In order to maintain confidentiality, documents will be designated using one of five classifications:

  • Public - Available to be viewed by anybody in the world.  All documents should have a designation but any document without a designation will be considered Public.
  • Members - Available to be viewed by CDISC membership.
  • Internal - Available to be viewed by anybody within CDISC (employees and contractors). 
  • Confidential - Available to only a restricted group of CDISC employees and/or contractors. 
  • Classified - Available to only a restricted group of CDISC employees.  The Department head has to approve sharing with anyone else.  

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  • Documents must include name, data of creation, version, date of last update (if applicable) and name of the employee or contractor in charge of the document. 
  • The employee or contractor who created the document will own it and must make sure that is review every year to check if there are updates that need to be make. 
  • When an employee leaves the company, all the document that he or she owns will be reviewed to make sure that they are still needed. The documents that are still needed for the company will be assigned to a new employee, who from this moment, is taking responsibility for the new documents. Documents that are not needed anymore will be transfer to a file until a retention period is reach. 
  • Documents can’t have a copy on a different location. 
  • If there are two or more duplicate documents and one is and update of the previous ones, the most recent update is the want that will stay on file and the others, after a revision, will go to the Retention Period. 
  • owner
  • last modified
  • Next review
  • status


Dispose / Archive