Purpose

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

Scope

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 extends from the Document Management Policy and is dependent on CDISC harmonized systems where documentation is created and 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.

Term	Definition
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. 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.

Role	Responsibilities
Document Owner	Creates, updates, archives documents based on their usefulness or sends them to legal hold.
Department Head	Responsible for document owner fulfilling responsibilities and assigns replacement document owners as appropriate.
System Administrator	Responsible for systems where documentation is created, maintained, and managed.

Instructions

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
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. 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.
2.0	Document Owner	Store the document in the appropriate CDISC system used by the Data Science 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.
3.0	Document Owner	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 With prior Department Head approval, an external system may be used to distribute/post
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
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
6.0	Department Head	Provide a valid document owner when a document owner leaves the department or company

General Workflow

Include a general workflow diagram that summarizes this Work Instruction.

Document Management Work Instructions

References

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

Page tree

Document Management Policy Work Instruction