Natural and Non-Prescription Health Products Directorate (Nnhpd)

TABLE OF CONTENTS

CLINICAL TRIAL APPLICATION

NATURAL AND NON-PRESCRIPTION HEALTH PRODUCTS DIRECTORATE (NNHPD)

Module 1 Administrative / Clinical Information 1.1 Table of Contents (Modules 1-3)  1.2 Application Information 1.2.1 NNHPD Clinical Trial Application and Attestation Form  1.2.2 Information on Prior-related Applications  / NA 1.2.3* Investigator’s Brochure  1.2.4* Protocol Synopsis and Evaluation Review Template (PCERT)  1.2.5* Study Protocol(s)  1.2.6 Informed Consent Document(s)  1.2.7 **Clinical Trial Site Information Form NA 1.2.8 Canadian Research Ethics Board(s) Refusals  / NA 1.2.9 Foreign Refusals NA 1.2.10 Letters of Access NA 1.2.11 Other Application-related Information: **Completed Qualified Investigator Undertaking form /NA Completed REB Attestation form NA Authorization form for a Third Party to Import the NHP  / NA Designated Party Authorization Form NA Letter of Attestation  List of related ongoing (authorized) CTs in Canada  / NA Copy of the discussions and decision of the pre-CTA  / NA consultation meeting 1.3 Electronic Review Documents  2 Common Technical Document Summaries 2.1 Common Technical Document Table of Contents NA 2.2 NA NA 2.3* Quality Overall Summary NA 3 Quality Data (supporting data) 3.1 Table of Contents of Module 3 NA 3.2 Body of Data NA 3.2.R. NA NA 1 3.3 Quality Literature References NA INSTRUCTIONS (ensure instructions are deleted prior to finalization)

1. Submission Format a. The CTA package should not be submitted/organized into binders, tabbed or stapled. b. The CTA package must be submitted as two hard and two electronic copies in a file format accepted by Health Canada c. For additional information, refer to the “Clinical Trials for Natural Health Products Guidance Document” dated October 2005. http://www.hc-sc.gc.ca/dhp- mps/prodnatur/legislation/docs/clini_trials-essais_nhp-psn-eng.php#1.4

2. Electronic Data Structure and Content: a. More information on acceptable electronic formats is available in Health Canada’s notice available at http://www.hc-sc.gc.ca/dhp- mps/prodpharma/applic-demande/guide-ld/ctd/notice_avis_ctd-eng.php b. All documents submitted in electronic format must be identical to the hard copies provided in the CTA. c. *These items should also be submitted in electronic format in a word processed format (Microsoft Word 2000, 2002, 2003, or in Corel WordPerfect versions 6, 7, 8, 9, or 10) on media accepted by Health Canada (e.g. CD-R conforming to the Joliet specification, and DVD-RAM and DVD+R/-R recorded in the Universal Disk Format (UDF) standard). d. All remaining applicable documents in Module 1, Module 2, and Module 3 should be submitted in hard copy and in electronic file of choice (i.e. word processed format, PDF files).

3. ** It is mandatory that the sponsor submit these items to the NNHPD prior to commencement of the trial. If the Qualified Investigator Undertaking (QIU) is ready at the time of the CTA submission, it should be included.