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Standard Operating Procedure (SOP) #4: Completion of the Guidance Document Template

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Standard Operating Procedure

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

Title

Completion of the Guidance Document Template

Doc. Number

GGP SOP #4

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
• 6. Reference Documents
  • 6.1 References
  • 6.2 Templates
• 7. Authors
• 8. Document Revision History

1. Purpose

The purpose of this procedure is to provide additional information (including examples) to assist with the drafting of a guidance document. It provides explanations, definitions and examples for the various sections of the guidance document template.

2. Scope

This procedure applies to all Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) staff responsible for drafting a guidance document. It should be read in conjunction with Standard Operating Procedure (SOP) #1 (Issue Analysis in TPD/BGTD) and SOP #2 (Guidance Development in TPD/BGTD).

This procedure should also be read in conjunction with the GGP Style Guide (Chapter 6 of the GGP Manual).

3. Definitions

Definitions applicable to the guidance development process are outlined in Chapter 2 of the GGP Manual.

4. Responsibilities

The Project Lead (with the input of a Working Group if one is formed) bears primary responsibility for drafting the guidance document in accordance with the guidance template. Additional roles and responsibilities for those involved in the issue analysis and guidance development processes are outlined in Chapter 3 of the GGP Manual.

5. Instructions

*Note that examples provided within this procedure are samples only and may not accurately reflect a published Health Canada guidance document.

The draft guidance document template should be used for draft documents being published for consultation. The final guidance document template should be used for final documents being published for implementation.

Cover Page

The "Guidance Document" title should remain (preceded by DRAFT in the draft guidance document template). Underneath, include the title of the guidance document. For draft guidance documents, the draft date should be included on the document and updated as the document is revised.

For draft documents, the Approval Date should be included. For final documents, the Date Adopted and the Effective Date should both be given.

For revised documents, the original Date Adopted should remain; a Revised Date should be added once Directorate (pl.) management approval is given for the adoption of the revised guidance document.

Foreword

This section should not be changed. The headers and footers should be modified to include the guidance document name and relevant dates (draft date, date adopted, effective date, revised date, etc.). There should be two headers and two footers (included in the template), which alternate even/odd pages; note that the Publications Unit (TPD) or Website Coordinator (BGTD) will include (or correct) these as part of their quality check before the document is posted.

Document Change Log

This section should only be included for revised guidance documents; otherwise click on Edit, Select Page and delete. An overview of the significant changes made to the guidance document should also be described in the accompanying Notice to Stakeholders.

Table of Contents

This section should include all major sections of the guidance document, as well as any appendices.

Section 1: Introduction

Section 1.1: Policy Objectives

Policy objectives outline clearly and concisely what the government is seeking to achieve, i.e. the larger aim or goal. They should be linked both to the relevant Acts and Regulations, and to Health Canada's objectives. This is not a statement of the purpose of the document.

Policy objectives should explain how to resolve the issue identified. Policy objectives should be stated in the infinitive, i.e. "To ensure...."

Policy objectives must be included within every guidance document and are developed as part of the issue analysis process. Depending on the nature of the issue, they may be developed and consulted upon separately from the guidance for implementation (operational details).

Section 1.2: Policy Statements

Policy Statements specify the policy (or position) that will achieve the policy objectives, and general principles to guide decisions on the issue. The policy statements will serve as the underpinning for the remaining text of the document, i.e. the guidance for implementation, which will describe how the policy statements will be applied.

The Policy Statements Section is not a mandatory component of every guidance document. The Project Lead (with the input of a Working Group if one is formed) should assess whether it is feasible to draft clear, concise statements describing the general principles of the document. Policy statements will usually be more appropriate for guidance documents that are process-related or broader in scope, and may be less appropriate for detailed scientific guidance documents.

Policy statements are developed (along with policy objectives) as part of the issue analysis process. Depending on the nature of the issue, policy objectives and statements may be developed and consulted upon separately from the guidance for implementation (operational details).

Section 1.3: Scope and Application

Each guidance document must include a Scope and Application section, which will describe the applicability of the guidance document. For example, a guidance document may apply to all stakeholders, to staff and stakeholders, or to specific stakeholders (e.g. manufacturers of Class IV medical devices). It may also be applicable to certain types of products, therapeutic classes, submissions/applications, or decisions.

If the guidance document supercedes an earlier document (policy, guidance, Information Letter, Notice, etc.), the following statement should be included: "This guidance document supercedes the Health Canada <policy, guidance, etc.>: <Title of superceded document>, which came into effect <effective date of superceded document>.

Section 1.4: Background

The guidance document may include a Background section, which will describe the history of this issue, including the triggers for the analysis and development of the guidance document. It should briefly describe the issue analysis process that resulted in the drafting of the guidance document. If the document is being revised, it may describe (at a high level) the major revisions made and the supporting rationale.

Note that if the guidance document is accompanied by an Issue Analysis Summary (IAS), the IAS will likely capture this information and this section likely will not be as detailed. In this situation it may be helpful to include a reference to the IAS in this section.

Section 2: Guidance for Implementation

The guidance for implementation section describes the operational details regarding the implementation of policy objectives and policy statements, for example, a process to be followed by a sponsor, submission requirements, performance targets, etc.

The Guidance for Implementation section should be included in every final guidance document published. Depending on the nature of the issue, a guidance document may be published for early consultation without this section (i.e. with just Policy Objectives, Policy Statements, and Scope and Application sections) - this would most frequently occur when the subject of the document was a significant new approach to TPD or BGTD business (e.g. probationary licensing, priority review, etc.).

Sub-sections within this section will vary depending on the nature of the issue and the guidance document being developed. Some examples follow; however, for most situations this section will need to be tailored to meet the needs of the issue at hand.

Note that a section on Roles and Responsibilities (likely Section 2.1) may be included in the guidance document, and should outline the roles and responsibilities of each of the key players (internal and external to the Directorate(s)) within the guidance document. This section will likely be more applicable for process-related documents than for very detailed scientific documents.

Project Leads should refer to recent documents posted on the TPD and BGTD websites for examples that may be relevant to the guidance document under development.

Appendices

An appendix contains detailed or technical information that is supplementary to the main text of a publication. Material properly relegated to an appendix includes explanations and elaborations that are not essential to the text but would be helpful to a reader seeking further clarification. This includes documents illustrating the text, long lists, official meeting minutes, or charts or tables.

The usual practice is to label a series of appendices by letter (Appendix A, B, C, etc.) if the information is not essential to the reader's understanding of the main text, and by upper-case Roman numeral (Appendix I, II, III, etc.) if the information is essential. Each appendix should be given a title and should be included in the Table of Contents.

Templates and Forms should not be appended to a guidance document; rather, they should be posted separately so that they can more easily be revised or updated.

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
• 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