Revision Date: 2023.09.29

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Table of Contents

I. Description

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1. Policies are organization-level documents that reflect company values at a high level.  Policies are reviewed on a routine basis (often annually) and generally should not contain process elements known to be subject to frequent change.  Sage policies are maintained in PowerDMS and are accessible Sage-wide.

2. SOPs are documents used to put organizational policy into action.  SOPs should generally discuss an overview of a process but should be supplemented by other process resources to further elaborate the full breadth and depth of a particular process. SOPs are approved by the Vice President for Research Governance and Ethics (or designee) and stored in Confluence.  Sage Employees have comments access to the SOPs to provide feedback. Draft versions will be maintained in a designated location in Google Drive, accessible to all members of the Governance team for editing.

3. Reliable Methods (RM) are process documents that provide detailed, step-by-step instructions for completing a task. Reliable Methods are meant to elaborate on other generalized instructions that are covered in SOP or Policy documents. Reliable Methods will also be finalized and stored in Confluence, and whenever possible, Reliable Methods should be associated with a corresponding SOP.  Reliable Methods are often also supplemented by a number of other Process Resources such as process diagrams, templates, checklists, etc.  These documents are not considered “Reliable Methods,” but fit into the overall hierarchy of process documents.  Process Resources should, whenever possible, point back to a higher-level SOP or Reliable Method to describe how it should be used.

See SOP01-RM01: Document Development Processes for Reliable Methods

Confluence will include a detailed list of Policies, SOPs, Reliable Methods and other Process Resources to be shared at the organizational level.  The list should adopt the naming convention below and include the resource number (if applicable), title, brief description, and a link to the location of the current document in Confluence. 

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1. Policies are numbered, named, and managed at the organizational level.

2. SOPs are numbered using a convention of SOP[##].  This convention helps provide organization and a simplified means for reference.  Examples:

   • SOP01

   • SOP02

3. Process resources, whenever possible, are numbered by linking their content to an associated SOP and appending a letter and number depending on the type of resource (as defined further below in VI.C.5). Adding numbering conventions to process resources helps provide organization and a simplified means for reference. Example:

   • SOP03-RM01 would be a Reliable Method related to SOP 3.

   • SOP05-T01 would be a template related to SOP 5.

   • SOP08-C01 would be a checklist related to SOP 8.

4. Where process resources are unrelated to a specific SOP, they are given a prefix of “SG” and a document label, followed by the next available number in succession. Examples:

   • SG-T01, SG-T02 would be two templates maintained by Governance that do not roll up to a specific SOP.

   • SG-R01: Governance Glossary is the general-purpose Governance Glossary, which does not roll up to a specific SOP.

5. Document or resource types should be limited to those described in this SOP to ensure that resources can be categorized in a standardized manner. Appended letters for various process resources:

   • Checklists: C

   • Diagrams: D

   • Forms: F

   • Reference: R

   • Reliable Methods: RM

   • Templates: T

   • Worksheets: WS

6. When resources are finalized, they should be given a version date in yyyy.mm.dd format.  For resources on Confluence, the version date should appear at the top of the page below the resource number and title.  Freestanding resources (e.g., a PDF document) should have the date visible on each page preferably in the footer, when feasible.

7. Past versions of process resources should be archived  as a PDF document in Google Drive to maintain an accessible, archived history of the process resources used at any point in time.

8. Draft versions should be saved in Google Drive in a designated location upon creation.  File naming should follow the standards described above with the addition of a date in yyyy.mm.dd format and “DRAFT” at the end of the filename.  This format will facilitate sorting by filename.  

9. Use SOP01-RM01: Document Development Processes for more details covering the creation and maintenance of Draft, Current and Archived document versions.

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