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

• Create a Name as follows according to the type of document.  Below are some examples:
  • 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.

• • • 2021-08-04 Data Science Meeting

• Identify a Category by adding: 
  • Class A - This kind of

• • document will be kept without any

• • modification since it was created for an event in the past. Examples of these documents are meeting papers and minutes.
  • Class B - This kind of informational document will

• • have a Stability Period.  When the stability period is exhausted, the document will need to be reviewed by the owner to decide if the document is reliable or if it needs an update

• • • e.g. 

• • • 2021-08-04 Data Science Meeting

• • • . Class A

• Establish 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. 

• • • 2021-08-04 Data Science Meeting

• • • . Class A. Internal
• 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  

• Store documents in SharePoint

•  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

documents only through the approved CDISC systems

.  

With prior Department Head approval, when appropriate an external system may be used to distribute/post.

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

confirm document reliability, or to update and add

time to the end of a document's Stability Period, or mark for archival.

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