Revision Date: 2023.09.29

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Table of Contents

I.  Description

This procedure describes the processes used by Sage Governance to create new or revised SOPs, Reliable Methods (RMs) or other documents.  Stages of the document development process include:

• Drafting

• Review and Approval

• Finalization & Posting Current Versions

• Archiving Past Versions

• Updating the Document Index

Organization-level Sage Policies will be revised, reviewed, finalized, posted, and archived in PowerDMS.  Sage Governance will adhere to the processes for using PowerDMS in developing and maintaining organization-level policies.

II.  Scope

This Reliable Method applies only to Sage Governance team members creating and maintaining SOPs, Reliable Methods and other Governance resources. 

III.  Definitions & Acronyms

N/A

IV.  Authorities/Responsibilities

From SG- SOP01:

 “The Vice President for Research Governance and Ethics is responsible for approving Policies and delegating 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).”

V.  Procedures

A. Drafting SOPs and RMs

Follow this Drafting process when:

• A completely new SOP or RM is being created, or,

• A revision is being made to an SOP, or,

• A revision is being made to a RM and the revision is not a simple/quick update (see V.D.).

1. If the “Draft” is a simple/quick revision to an existing RM posted in Confluence, see V.D; otherwise, continue to V.A.2

2. For revisions to an existing SOP or RM, make a copy of the document found in the CURRENT folder using the File/Save a Copy command, and save it in the Google Drive folder:

“DRAFTS – Policies – SOPs – RMs – Resources”

3. For new or converted SOPs or RMs, use an existing Document template, if applicable. i.e.:

   1. SOP01-T1: SOP Template

   2. SOP01-T2: RM Template

4. For revisions to an existing SOP or RM:

   1. Navigate to the “CURRENT” folder and use the File/Save a Copy command of the Current (non-Tracked) Google Doc, then, 

   2. Use the Move button to save the copy to the DRAFTS file. 

5. Document renaming is not required.

6. If the draft is revising an existing document, track the changes using Suggest mode.  Add comments as needed.

7. Update the date in the filename when the document is updated.  To avoid confusion, the revision date in the top of the document itself should remain highlighted as a date placeholder until it is finalized.

8. Once a Draft is ready for review, proceed with VI.C. for SOPs or VI.D for RMs.

B. Resources Created Outside of Google

Some resources are created in other software mediums such as LucidChart.  Whenever possible and feasible:

1. Resource authors should attempt to incorporate these resources into new or existing SOPs or RMs.  For example, include a process diagram or decision chart into a new or existing document.

2. If resources do not fit well into an existing SOP or RM, resource authors should consider creating another type of freestanding document to house the resource and ensure it is indexed and referenced in Confluence.

The purpose of creating a freestanding document is to help:

1. Differentiate between drafts and current versions,

2. Ensure that the resource is used properly and consistently, and to

3. Maintain a document archive.

C. Review of SOPs

Prior to SOPs being finalized and posted, the SOP should be reviewed by:

• A peer who is involved in completing the work (if available).

• A member of the Governance Senior Team.

• The Vice President for Research Governance and Ethics or designee(s)

To obtain review:

1. Add a comment to the Draft Google Document,

2. Tag the person for review,

3. Include a due date, when possible, to maintain a controlled review timeline,

4. Repeat the tagging steps with each person involved in the review process,

5. The Vice President for Research Governance and Ethics should be the final reviewer who indicates the SOP can be finalized.  (At this time, “approval” of the final review will be an informal process verified through comments in the Google Document only.)

When review is complete, proceed to VI.E.

D. Review of RMs and Other Process Resources

RMs and other process resources may be subject to frequent “simple/quick” changes in order to facilitate an accurate reflection of the procedures that should be followed on a daily basis.  

1. Review of New Reliable Methods

   1. Consult your manager to determine who should be part of the RM review process and/or who should approve.

   2. To obtain review:

      1. Add a comment to the Draft Google Document,

      2. Tag the person for review,

      3. Include a due date, when possible, to maintain a controlled review timeline,

      4. Repeat the tagging steps with each person involved in the review process. (At this time, “approval” of the final review will be an informal process verified through comments in the Google Document only.)

When review is complete, proceed to VI.E.

2. Review of Revisions to Reliable Methods: If a member of the Sage Governance Team identifies inaccuracies in a RM or similar process resource, take one of the following two approaches.

   1. If the team member is certain of the accuracy of the update:

      1. Make the update directly into Confluence.

      2. Update the version date.

      3. Create a Final version following VI.E.

   2. If the team member is uncertain of the accuracy of the update and needs input:

      1. Add a comment into Confluence to indicate the additional process steps or clarifications that need to be made.

      2. Start a formal Draft following the process in VI.A.

E. Finalization & Posting of Current Documents to Confluence

Once all review processes are completed (as applicable).

1. Current versions of Governance documents should be saved to the Google Drive folder:

“CURRENT – Policies – SOPs – RMs – Resources”

** Up to three documents may represent the “Current” version of a document and these must be clearly labeled:

1. A Tracked version showing all changes made between the last version and present version.  This is done to create an audit trail.

2. A Clean version in Google Docs format.

3. A PDF version for ease of sharing.

2. If a current version of the document exists, move the existing “current” document to the ARCHIVE folder using the process in VI.F.

3. Add a version date to the document on the top left corner under the title.

4. Move a copy of the Draft version to the CURRENT folder.  Use the following naming scheme for this “tracked” version.

   1. [SG-SOPXX-XX] [DATE in yyyy.mm.dd] [Document Title] 

5. Resolve all tracking/suggestions, comments and highlights, unless any existing comments are there to inform additional conversation for the next draft.

6. If the document is new:

   1. Create a new Page in Confluence and place the page in the correct indexing hierarchy in the menu on the left of the page.

   2. Copy/Paste the content of the document into Confluence.

   3. Add the document to Document Index Confluence Page.

7. If the document is not new:

   1. Make the appropriate updates to the existing Confluence Page.  Ensure that the version date and document history section is updated.

F. Archiving Past Versions

1. Archived versions of Governance documents should be saved to the Google Drive folder:

“ARCHIVE – Policies – SOPs – RMs – Resources”

2. Archived version follow the naming scheme:
   [SG-SOPXX-XX] [DATE in yyyy.mm.dd] [Document Title] [ARCHIVE]

3. Prior to finalizing a revised document, ensure an archive version is created in two versions.

   1. When applicable, a PDF version.

   2. A Google Docs version.

4. Ensure that file naming and file version dating place the documents together when sorted by filename.

G. Updating Superseded or Obsolete Confluence Pages

Whenever possible, existing SOPs, RMs, or other resources in Confluence should not be deleted in order to ensure that any existing links created by other teams do not suddenly break upon the document update.  Instead of deleting, Governance should place a clear header on the Confluence indicating the status of the document as Superseded or Obsolete and providing a link to the updated resource.  The page can be moved to an appropriate archiving section in the document menu hierarchy on the left of the screen.

VI.  Associated Documents and Resources

• SG-SOP01: Management of Policies, SOPs, and Process Resources

• SOP01-T01: SOP Template

• SOP01-T02: RM Template

VII.  Revision History