Canadian Institutes of Health Research
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Homepage:https://cihr-irsc.gc.ca/
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Disclosure of confidential business information 1. Request for disclosure of confidential business information (CBI) 2. Disclosure of confidential business information 3. Completed requests for disclosure of confidential business information under s21.1(3)(c) of the Food and…
Draft guidance on proposed new Clinical Trials Regulations (GUI-0100) This draft guidance is for consultation only. For current guidance please see the existing guidance document: Part C, Division 5 of the Food and Drug Regulations “Drugs for Clinical Trials Involving Human…
Draft guidance on clinical trial applications for clinical trial sponsors Download in alternative format (1.15 MB, 125 pages) This draft guidance is for consultation only. For current guidance, please see the existing Guidance document for clinical trial sponsors: Clinical trial…
Guidance for Industry: Standards for Clinical Trials in Type 2 Diabetes in Canada (PDF Version - 149 K) Contact: OCT_BEC_Enquiries September 24, 2007 Notice Our file number: 07-122151-509 Release of final Health Canada document: Standards for Clinical Trials in Type 2 Diabetes in…
Update: Requirements for Tuberculosis Screening of Healthy Volunteers in Phase I Clinical Trials involving Immunosuppressant Drugs or Drugs with Immunosuppressant Properties December 18, 2007 Our file number: 07-129093-226 (PDF Version - 20 K) Contact: OCT BEC Enquiries Notice On…
Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III) This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to submit a form, you must use only…
Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase II (QOS-CE (CTA - Phase II)) This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to submit a form, you must use only…
Quality Overall Summary - Chemical Entities Clinical Trial Application - Phase I (QOS-CE (CTA - Phase I)) This HTML document is not a form. Its purpose is to display the information as found on the form for viewing purposes only. If you wish to submit a form, you must use only…
Guidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals (PDF Version - 335 K) Contact: Office of Clinical Trials Notice March 12, 2009 Our file number: 08-134763-687 Health Canada is pleased to announce the…
Guidance Document: Preparation of Clinical Trial Applications for use of Cell Therapy Products in Humans (PDF Version - 247 K) Date: 2015/08/21 FOREWORD Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing…
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