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Purpose

Ensure This work instruction ensures that documents are being managed and maintained appropriately. This work instruction It sets out the steps to enable the Data Science Team to create, maintain, distribute, maintain, and when necessary, deleted archive documents.

Scope

Information collected is summarized in the Project Charter (TAs) that is submitted to the Team Leads/TAPSC for approval to proceed with the next stage of the development process.The scope of this work instruction is focused solely on documentation that Data Science needs to retain for information purposes and intentionally omits letters, emails, etc. 

Prerequisites

This work instruction needs extends from the Document Management Policy and a system where is dependent on CDISC harmonized systems where documentation is created , maintained, and managedand maintained.

Definitions

List terms (abbreviations, acronyms, technical jargon) referenced in this Work Instruction useful at adding clarity. Put "Not applicable." if this section is not applicable.

TermDefinition
Stability PeriodThe 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.  The stability period is set at the time of creation or update and can be no longer than 2 years.

Roles & Responsibilities

Lists all roles and their responsibilities relevant to this Work Instruction.

RoleResponsibilities

Document Owner

Creates, updates, archives documents based on their usefulness or sends them to legal hold.

VP Data ScienceDepartment Head

Responsible for document owner fulfilling responsibilities and assigns replacement document owners as appropriate.

System AdministratorResponsible for systems where documentation is created, maintained, and managed. 

...

Describe each step to be taken to complete the scope of this Work Instruction in the prescribed sequence. Use active verb verbs in the Instructions column.

Step #RoleInstructions
1.0Document Owner
Creates

Create a document

using the

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.
2.0Document Owner
Distributes or Stores

Store the document

through

in the appropriate CDISC system used by the Data Science

Team (Outlook, Confluence Wiki, SharePoint / OneDrive, Azure DevOps Wiki, GitHub Wiki)

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.
3.0Document Owner

Distribute documents only through the approved CDISC systems.  

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

4.0Document Owner

Maintain

UseDocument OwnerMaintains

the document to make sure that the content is accurate and

availableDocument OwnerReviews the document after one year of its creation

reliable

  • Review the document at the end of the stability period and determine if it is still relevant
  • Update
Document OwnerUpdates
  • the document if it is still needed
for
  • by the department but needs
added informationDocument OwnerSends the document to Archived Period if
  • additional or updated information and reset its stability period
  • Archive the document if it is not needed
for the department after the one year reviewVP Data ScienceDecides if it is time to delete the document or give a one-year extensionVP Data ScienceReestablishes the document to its previous location and owner after two years in Archived Period if he considers that the document could be used again
  • by the department 
5.0Department Head

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.

6.0Department Head

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

VP Data ScienceDeletes the document after two years in Archived Period if is not needed anymore


General Workflow

Include a general workflow diagram that summarizes this Work Instruction.


Gliffy Diagram
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Document Management Work Instructions
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Document Management Work Instructions
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References

List references pertinent to this Work Instruction, e.g., COP-001.

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