Revision Date: 2023.07.0309.29
Table of Contents
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I. Description
This SOP defines the numbering, naming, and organization system Sage Governance uses to manage various resources that guide governance activities. These resources include:
Policies
Standard Operating Procedures (SOPs)
Process resources, such as:
Checklists
Decision Charts or Trees
Forms
Process Diagrams
Reference Resources
Templates Templates
Reliable Methods
Worksheets
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II. Objectives
Identify and define the key resource types used by the Sage Governance team.
Provide a framework to develop, organize, and share key resources.
Define resource management, including:
Standard templates for SOPs, Reliable Methods (RM), and Checklists.
Numbering and naming system.
Designating specific systems for sharing finalized documents and collaborating on revisions.
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III. Scope
This SOP covers Sage Governance resources only. All Sage Governance team members should use and follow this SOP when creating and managing process resources.
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IV. Definitions & Acronyms
Checklist – Checklists are Process Resources used to delineate and document the completion of steps in a process.
Policy – A Policy is a statement of interpretation and understanding by management designed to guide the work of the organization (see Policy Development). Policies are organization-level documents that reflect company values at a high level. Policies are often in place to address a specific legal or regulatory function and may discuss high-level concepts and requirements that are further addressed in a larger set of SOPs and other process resources.
Process Diagram – Process diagrams may include flow charts, decision charts, or other diagrammatic depictions of work.
Process Resource – Process resource is a general term to include a wide variety of different documents, forms, diagrams, etc., which may be used to inform how work is done.
Reliable Method (RM) – Reliable Methods are documents that provide detailed, step-by-step instructions for completing a task. RMs are meant to elaborate on other generalized instructions that are covered in SOP or Policy documents. Unlike SOPs or Policies, RMs are meant to be updated on a continual basis to best reflect the most reliable, comprehensive method for completing work.
Standard Operating Procedure (SOP) – For Governance, SOPs are documents used to operationalize organizational policy. Governance SOPs implement standards by explaining the operational principles that direct the responsibilities and activities carried out by Sage employees. SOPs should generally discuss an overview of a process, but often should be supplemented by other process resources, particularly Reliable Methods.
Template – Templates may include any document that provides an example set of language and/or formatting for completing a task such as a template letter that can be customized with case-specific content, or a template agreement.
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V. Authorities/Responsibilities
The Vice President for Research Governance and Ethics is responsible for approving Policies and delegating senior members of the Governance team to develop and maintain SOPs.
All Governance team members are responsible for writing and maintaining process resources through the course of their daily work and sharing them with an appropriate audience (i.e., internal to Governance, shared broadly with the entire organization, or potentially shared externally through an appropriate medium). Reliable Methods must comply with relevant SOPs and organizational policies.
All Governance team members should adhere to this SOP.
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VI. Procedures
A. Hierarchical Structure for Policies, SOPs and Reliable Methods
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.
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.
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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B. Standard Templates for Policies, SOPs and Reliable Methods
Policies should match the standard template established at the organizational level.
A standard template is available for creating new Governance SOPs. It is titled per naming convention as “SOP01-T1: SOP Template”. To promote consistency, Governance SOPs should contain all of the following sections:
Table of Contents
Description
Objectives
Scope Scope
Definitions & Acronyms
Authorities/Responsibilities
Procedure (may be given a different header title)
Associated Documents and Resources
Revision History
A standard template is available for creating new Reliable Methods. It is titled per naming convention as “SG-SOP01-T2: Reliable Method Template”. The template elements should be used whenever possible to promote consistency but should be adapted to meet the needs of any given process. Key sections and elements can include:
Table of Contents
Description
Objectives
Roles or Audience
Procedure
Associated Documents and/or Resources
Revision History
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C. Standard Numbering and Naming System
Policies are numbered, named, and managed at the organizational level.
SOPs are numbered using a convention of SOP[##]. This convention helps provide organization and a simplified means for reference. Examples:
SOP01
SOP02
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.
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.
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
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.
Past versions of process resources should be archived archived as a PDF document in Google Drive to maintain an accessible, archived history of the process resources used at any point in time.
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.
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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D. Documents Managed in Confluence and Posted in Synapse
Some non-Policy/SOP/Reliable Method documents are posted in Synapse and maintained using a feature of Confluence. These documents include the Synapse Documents and AD Knowledge Portal Help Documents. The process of maintaining these documents is delineated in SOP01-RM02: Maintenance of Synapse Docs.
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AD Knowledge Portal Documents are managed by the Alzheimer’s Disease Translational Research (ADTR) team, though the governance lead supporting the AD Knowledge Portal will sometimes be asked to support or collaborate on updates to the AD Portal Help Documents.
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VII. Associated Documents and Resources
PowerDMS for Sage Policies
Sage Policy Template
SOP01-T01: Standard Template for SOPs
SOP01-T02: Standard Template for Reliable Methods
SOP01-RM01: Document Development Processes
SOP01-RM02: Maintenance of Synapse Docs
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VIII. Revision History
Version # |
, Date | Description |
V1, 2023.09.29 | Original version |