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Term | Definition |
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Time To Live (TTL) | This is how long a document is considered to be reliable before it must be reviewed and either confirmed reliable and necessary, updated, or marked for archival. |
Stability Period | The period from the creation or update of a document when it is considered is accurate and reliable, after which it must be reviewed, confirmed reliable again, updated, or archived |
Roles & Responsibilities
Lists all roles and their responsibilities relevant to this Work Instruction.
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Step # | Role | Instructions |
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1.0 | Document Owner | Create a document and title it with a name, category, and confidentiality classification. - Create a Name as follows according to the type of document:
- 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. Data Science Meeting 08-04-2021. 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. Data Science Meeting 08-04-2021. 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.
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2.0 | Document Owner | Store the document in the appropriate CDISC system used by the Data Science Team (Confluence Wiki, SharePoint / OneDrive, Azure DevOps Wiki, GitHub Wiki)Team - 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.
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3.0 | Document Owner | Distribute document only through the approved CDISC systems - Outlook and SharePoint/OneDrive (if it's too large for email) |
4.0 | Document Owner | 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
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5.0 | Department Head | 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
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6.0 | Department Head | Provide a valid document owner when a document owner leaves the department or company
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