Standard Operating Procedure (SOP) #3: Revisions to Published Documents in TPD/BGTD

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Standard Operating Procedure

TPD SOP Template WP Version 1: Effective Date 2006-04-01

Title

Revisions to Published Documents in TPD/BGTD

Doc. Number

GGP SOP #3

Version

2.0

Bureau / Office / Area

Good Guidance Practices WG

Status

Final

Effective Date

August 2007

Approved for external consultation by

TPD Management Committee
BGTD Management Committee

Date

July 27, 2007 (TPD-MC)
August 1, 2007 (BGTD-MC)

Table of Contents

• 1 Purpose
• 2 Scope
• 3 Definitions
• 4 Responsibilities
• 5 Instructions
  • 5.1 Administrative Revisions to Published Documents
  • 5.2 Significant Revisions to Published Documents
• 6 Reference Documents
  • 6.1 References
  • 6.2 Templates
• 7 Authors
• 8 Document Revision History

1 Purpose

This procedure is intended to complement Standard Operating Procedure (SOP) #1 (Issue Analysis in TPD/BGTD) and SOP #2 (Guidance Development in TPD/BGTD). It provides the Therapeutic Product Directorate (TPD) and the Biologics and Genetic Therapies Directorate (BGTD) with a process by which published documents will be revised.

2 Scope

This procedure applies to revisions to TPD/BGTD published documents (particularly issue analysis summaries, guidance documents and templates), including those which are Bureau/Centre/Office-specific.

All TPD and BGTD staff must adhere to this procedure, including employees and contractors working for the Directorate(s).

Included within this procedure are the steps appropriate to the revision of published documents. It is recognized that the circumstances of each issue will be different and therefore this procedure allows for tailoring, depending on the complexity of the issue being considered. Judgement will need to be exercised in deciding on the appropriate level of effort for each revision exercise.

3 Definitions

Definitions applicable to this process are outlined in Chapter 2 of the Good Guidance Practices (GGP) Manual.

4 Responsibilities

Roles and responsibilities of those involved in this process are outlined in Chapter 3 of the GGP Manual.

5 Instructions

This procedure provides an overview of the steps involved in revising a published document. Documents published by TPD and BGTD will be periodically reviewed to determine whether they are still relevant and current and whether changes are needed. Documents will also be evaluated to determine their effectiveness in solving the issue originally identified. In addition, outside of these regularly scheduled activities, it may become necessary to revise a published document.

As outlined in SOPs #1 and #2, a Contact will be identified for each published document, to which comments will be directed. The Contact is responsible for receiving, reviewing and responding to comments and questions regarding the published document. The Contact must keep a record of comments received; if there are significant concerns with the guidance document, the Contact may decide to review and possibly to revise the document (potentially outside of the normal review schedule).

The standard review period is two years; at the end of this time, the Contact will decide whether the document as a whole is still relevant and necessary, and if so, will review it to determine whether any revisions are needed. The nature of the revision (administrative or significant) will determine the process to be followed. Timing of the revision will depend on TPD/BGTD priorities and available resources.

If a document is no longer relevant and necessary and is to be removed from the website, a Notice to Stakeholders will be drafted to provide the rationale for the removal of the document. This will be posted in place of the document for at least six months.

5.1 Administrative Revisions to Published Documents

If the revisions to the document are expected to be administrative, the impact on internal staff and external stakeholders is expected to be minimal and the document may be published without a formal consultation period. Administrative changes will normally be limited to the following:

• updating a document when names, addresses or organizations have changed;
• providing a clarification of current practice, which does not change the policy objectives or operational requirements of the document; and
• changing the format of the document (where the content does not change); the exception is a template, where a change in format may affect staff or stakeholders and therefore will not normally be considered to be administrative.

The Contact may be the Project Lead responsible for making administrative revisions, or a new Project Lead may be identified (by the Lead Director/Senior Manager or Directorate Management Committee (DMC) if necessary). The nature of the administrative changes to the document and the reasons for the revisions must be documented on file (a brief issue analysis summary may be drafted for this purpose). The Notice to Stakeholders published with each document should explain the nature of the revisions and that they are being issued without consultation. The Notice will also give the Contact to whom concerns or questions about the document will be raised after publication; the Contact will review each concern or question and may recommend further revision to the document as appropriate.

Once the revisions are completed, the Project Lead will send the revised document and accompanying Notice to Stakeholders to the Publications Unit (TPD) or Website Coordinator (BGTD) who will perform a quality check of the documents and prepare them for posting. The Publications Unit/Website Coordinator will return the documents to the Project Lead for approval; once approved, the Project Lead will forward the documents to the Lead Director/Senior Manager.

When the Lead Director/Senior Manager is satisfied with the documents, the Director will sponsor the item to the Management Committee of the affected Directorates. DMC approval will indicate agreement that the revisions are administrative and no consultation is necessary. The date of the date of the last DMC approval becomes the Approval Date recorded in the meeting notes. When approval is granted, it is the responsibility of DMC members to communicate to their Bureau/Centre/Office the revised document.

The Project Lead will arrange for the revisions and the Notice to Stakeholders to be translated and will ensure that the translated versions are verified and match the originals. The Project Lead will complete any additional documents needed (as identified by the Publications Unit/Website Coordinator) and will forward them to the Publications Unit/Website Coordinator.

The Publications Unit/Website Coordinator will coordinate the posting of documents with the webmaster; it is the Project Lead's responsibility to coordinate the distribution of announcements to stakeholders, either through the Director General's Office of each affected Directorate or another unit or area as appropriate.

5.2 Significant Revisions to Published Documents

If the revisions to the document are expected to be significant, the full issue analysis process outlined in SOP #1 will be followed. The issue analysis summary drafted as part of this procedure will fully explore the reasons precipitating the review/revision of the document, options for revision of the document and recommendations with supporting rationale. If the outcome of the analysis is to revise (or create) a guidance document, this will be developed in accordance with SOP #2. Revised documents will be published internally and externally for full consultation.

A document change log should be included within the revised guidance document. The Notice to Stakeholders that accompanies the guidance document should outline the major revisions to the last version of the document. The issue analysis summary may also be published.

If the review of (and possible revisions to) the document has been precipitated by an urgent health or safety matter, the expedited issue analysis and guidance development processes (Section 5.2) of SOP #1 and #2, respectively, may be followed at the discretion of the relevant DMC(s). In this situation, an IAS will be drafted as above and may be accompanied by a new or revised guidance document. Revised documents may be drafted and published for immediate implementation, followed by internal and external consultation.

6 Reference Documents

6.1 References

GGP SOP #1: Issue Analysis in TPD/BGTD
GGP SOP #2: Guidance Development in TPD/BGTD

6.2 Templates

The following templates are located in Chapter 5 of the GGP Manual:

• Draft Guidance Document
• Final Guidance Document
• Issue Analysis Summary
• Notice to Stakeholders

Additional templates may be needed and are identified in the Reference SOPs.

7 Authors

TPD/BGTD Good Guidance Practices Working Group.

8 Document Revision History

Version	Change Made	Effective Date
1	Initial issuance of document for internal consultation	September 2005
1.1	Revisions after internal consultation.	April 2006
1.2	Revisions after DMC discussion. Issuance for external consultation	May 2006
1.3	Revisions after external (and internal) consultation.	April 2007
2.0	Final version posted.	August 2007