Page History

Create a document and title it with a name, category, and confidentiality classification.

• Create a Name by...as follows according to the type of document:
  • Emails - Internal Emails can just have the title of the subject. External Emails need to have "CDISC" + title

  • SOPs - SOPs will include numbers at the end of the title according to the Standard

  • Work Instructions - Name of the work instruction + "Work Instructions"
  • Policies and guidance - Name of the policy + "Policy" + Version
  • Meeting papers and minutes  - "Data Science" + "Meeting" + date
  • Education material - Name of the topic + Version
  • Reports - Name of the report + "Data Science"
  • Contracts  - Name of the employee or contractor + "Contract" + "Confidential"
  • Presentations  - Name of the presentation + "Data Science"
    • e.g. Data Science Meeting 08-04-2021
• Identify a Category by ...adding: 
  • Class A - This kind of documents will be kept without any modifications and for as long as the department exists as these kinds of documents do not need an update for the reason that they were just created to resume an event in the past
  • Class B - This kind of document will be revised every year and the owner will decide if the document needs an update or it is not needed anymore
    • e.g. Data Science Meeting 08-04-2021. Class A

• Establish the Confidentiality by...Confidentiality by adding any of the following at the end of the name:
  • 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.   
    • e.g. Data Science Meeting 08-04-2021. Class A. Internal
  • e.g.
• Documents that are created have a default stability period from the date of creation that specifies the minimum time the document is expected to be accurate and reliable.

Store the document in the appropriate CDISC system used by the Data Science Team (Confluence Wiki, SharePoint / OneDrive, Azure DevOps Wiki, GitHub Wiki)

• Store documents in SharePoint/OneDrive when they are Policies and Standard Operation Procedures.
• Store documents in Confluence Wiki when they are used to collaborate and share information with CDISC and CDISC Members.
• Stoe documents in Azure DevOps Project Wiki that are used for the project and technical artifacts and maybe a draft of published content to GitHub Wiki.
• Store documents in the GitHub Wiki that are pertinent to Open Source projects' technical artifacts.

Distribute document only through the approved CDISC systems - Outlook and SharePoint/OneDrive (if it's too large for email)

• Distribute documentation via MSFT Outlook Email
• Distribute documentation that is too large for email by placing it in Sharepoint/OneDrive

Maintain the document to make sure that the content is accurate and reliable

• Review the document at the end of the stability period and determine if it is still relevant
  
• Update the document if it is still needed by the department but needs additional or updated information and reset its stability period
• Archive the document if it is not needed by the department 

Send to Document Owner to update and/or confirm document reliability and add one year to the end of a document's Stability Period or mark for archival.

• Reestablishes the document to its previous location and owner after two years in Archived Period if he considers that the document could be used again
• Deletes the document after two years in Archived Period if is not needed anymore

Provide a valid document owner when a document owner leaves the department or company