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Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verbs in the Instructions column.
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:
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documents - document will be kept without any
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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 - 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
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be revised every year and - need to be reviewed by the owner
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will - to decide if the document is reliable or if it needs an update
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or it is not needed anymore- 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) - 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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General Workflow
Include a general workflow diagram that summarizes this Work Instruction.
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