Summary - Use of Positron-emitting Radiopharmaceuticals in Basic Clinical Research

Overview

The purpose of this guidance document is to provide information to sponsors who use positron-emitting radiopharmaceuticals in basic clinical research studies and to assist them in satisfying applicable federal regulatory requirements as set out in Sections C.03.301 to C.03.319 of the Food and Drug Regulations.

Who this guide is for

• Sponsors who use positron emitting radiopharmaceuticals in basic clinical research studies
• Persons who intend to become sponsors

In this guide

• Foreword
• Table of Contents
• 1. Introduction
  • 1.1 Purpose/Overview
  • 1.2 Scope and application
  • 1.3 Policy objectives
  • 1.4 Policy statements
  • 1.5 Background
  • 1.6 Glossary
    • 1.6.1 Acronyms
    • 1.6.2 Definitions
• 2. Guidance for implementation
  • 2.1 Roles and Responsibilities
    • 2.1.1 Section C.03.301 Sponsor
    • 2.1.2 Section C.03.306 Research Ethics Board
    • 2.1.3 Paragraph C.03.315 (3)(f) Qualified Investigator
  • 2.2 Section C.03.303 Limits on the Distribution of the Study Drugs
  • 2.3 Study Criteria
    • 2.3.1 Subsection C.03.305 (1) Study Requirements
    • 2.3.2 Subsection C.03.305 (2) Exemptions
  • 2.4 Overview of the Application, Regulatory Review, and Notification Process
    • 2.4.1 Subsection C.03.307 (1) Criteria for Application
    • 2.4.2 Subsection C.03.307 (2) Information Required
  • 2.5 Good Clinical Practices and Good Manufacturing Practices
    • 2.5.1 Paragraph C.03.311 (a-h) Good Clinical Practices
    • 2.5.2 Paragraph C.03.311 (i) Good Manufacturing Practices
  • 2.6 Section C.03.312 Labelling Requirements
  • 2.7 Section C.03.313 Request for Additional Information
  • 2.8 Section C.03.314 Adverse Reaction Reporting
  • 2.9 Section C.03.315 Records Related to Basic Clinical Research Studies
  • 2.10 Section C.03.316 Discontinuance of a Study
  • 2.11 Sections C.03.317, C.03.318 and C.03.319 Suspension, Reinstatement and Cancellation
• 3. Contact Information
  • 3.1 Office of Regulatory Affairs
• 4. Basic Research Application: PERs (BRAP)
  • 4.1 BRAP Submission Content and Format:
  • 4.2 Filing a BRAP

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Details and history

Published: [Month DD, YYYY]

Updated: May 18, 2015 (see all updates)

Consulted: [Month DD, YYYY] (see all consultations)

Part of topic(s): Guidance on legislation, [other relevant topic or content]

For assistance

Contact the Office of Regulatory Affairs (ORA) if you need assistance:

By phone: 613-957-1722

By e-mail: hc.bgtd.ora.sc@canada.ca

By mail:
100 Eglantine Driveway, Tunney's Pasture
Address Locator 0601C
Tunney's Pasture,
Ottawa, Ontario
K1A 0K9