Health Canada Clinical Trials

Transparency And The Drug Approval Process At Health Canada
Post all clinical trials reviewed by Health Canada to approve a drug, published and unpublished, on the Health Canada website. 2. Canada, a private health information company, reports rates of use peaking in 2002, when 81 per cent of ... Document Viewer

Trials And Tribulations - Healthcarecan.ca
By Joe McAllister Trials and tribulations As a declining share of global clinical trials threatens the future of health research in Canada, a national ... View Document

Clinical Trial Site Inforamtion (CTSI) Form
NOTICE: Release of a draft updated Clinical Trials Site Information (CTSI) form and the addition of supporting instructions for completing the CTSI form 4 Specify the Health Canada Central Registry (CR) File Number, if assigned. ... Retrieve Doc

Class II-IV Medical Device Investigational Testing In Canada
Class II-IV Medical Device Investigational Testing in Canada Canadian Medical Device Classifications Division of the Medical Devices office of Health Canada. Clinical trials for medical devices are not classified by phased development as with drugs (i.e., Phase I ... Access Full Source

Merck KGaA, Darmstadt, Germany, Pfizer And Syndax Announce Collaboration To Evaluate Combination Of Avelumab And ...
Merck KGaA, Darmstadt, Germany, Pfizer and Syndax Pharmaceuticals, Inc. announced today that they have entered into a collaboration agreement to evaluate avelumab*, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, in combination with Syndax’s entinostat, an investigational oral small molecule that targets immune regulatory cells , in patients with heavily pre-treated ... Read News

Xeljanz (tofacitinib) - What You Need To Know - About.com Health
Xeljanz (tofacitinib) - What You Need to Know. How Did Xeljanz Perform in Clinical Trials? and 5 clinical trials which evaluated the ACR 20 response to Xeljanz, as well as DAS28 and Health Assessment Questionnaire results. ... Read Article

Protocol (science) - Wikipedia, The Free Encyclopedia
In a clinical trial, the protocol is carefully designed to safeguard the health of the participants as well as answer specific clinical trials conducted are widely expected to conform to and report the information called for in the Though tailored to health and medicine, ... Read Article

An Action Plan To Help Attract More Clinical Trials To Canada
To Your Health & ProsperityAn Action Plan to Help Attract More Clinical Trials to Canada Draft March 30, 2012 6 pharmaceutical, vaccine, or device companies. ... Access Doc

Guidance For Clinical Trial Sponsors
Guidance for Clinical Trial Sponsors Establishment and Operation of Clinical Trial Data Monitoring Committees Additional copies of this guidance are available from: ... Access Doc

Clinical Trials Of Natural Health Products And Functional Foods
Clinical Trials of Natural Health Products and Functional Foods Are you considering a clinical trial for your natural health product or functional food? ... Get Doc

The Canadian Clinical Trials Asset Map (CCTAM)
The Canadian Clinical Trials Asset Map (CCTAM) Jared Rhines, Vice President, Scientifics and Strategic Affairs, Canada’s Research-Based Pharmaceutical Companies (Rx&D) ... Access Full Source

7th Annual Phase I Clinical Trials - IIR USA
7th Annual Phase I Clinical Trials Regulatory Framework for Conducting Phase I Studies: a Comparison Between U.S., European Union and Canada Thursday, October 12, 2006 ... Fetch Content

FAQs Clinical Record Retention
FAQs Clinical Record Retention . What is a clinical research record? DAIDS defines clinical research records as the essential and source documents found on the list in ... Get Document

FDA Perspective On International Clinical Trials
FDA Perspective on International Clinical Trials Kassa Ayalew, M.D., M.P.H. Acting Branch Chief . Division of Good Clinical Practice Compliance ... Fetch Document

CLINICAL TRIAL ADDENDUM - Berkley Canada - Home
GENERAL CLINICAL TRIALS INFORMATION. Health Canada or other equivalent government entity in respect . This Clinical Trial Supplemental Questionnaire attaches to and forms part of the Life Science Application. ... Retrieve Content

HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) - WHO
Introduction Good Clinical Research Practice (GCP) is a process that incorporates established ethical and scientifi c quality standards for the design, ... Return Doc

Health Products And Food Branch Inspectorate
Health Canada / Health Products and Food Branch Inspectorate Guidance Document - Annex 13 Current Edition of GMP Guidelines Drugs Used In Clinical Trials (GUI-0036) / Dec 1, 2009 Page 2 of 25 ... View Document

Chronic Lymphocytic Leukaemia: KOL Insight
NEW YORK, Jan. 5, 2016 /PRNewswire/ -- In the last few years the emergence of new targeted therapies such as AbbVie's/Janssen's kinase inhibitor Imbruvica (ibrutinib) and Gilead's P13K inhibitor Zydelig ... Read News

Institution/Investigator-Initiated Clinical Trials In Canada
Institution/ investigator-initiated clinical trials in Canada with drug products that are already available on the market in Canada. That means that the content ... Fetch Full Source

[NAME OF NATIONAL REGULATORY AUTHORITY] PROCEDURE FOR SUBMISSION
[NAME OF NATIONAL REGULATORY AUTHORITY] PROCEDURE FOR SUBMISSION OF CLINICAL TRIAL APPLICATIONS OF VACCINES AND BIOLOGICALS IN Clinical Trials of Vaccines & Biological medicines [National Regulatory Authority of Country] 4.5 For Hospital or Public Health Clinic Sites ... View Doc

Supports For Investigator-Initiated Clinical Trials Research ...
Investigator-initiated clinical trials represent an important component of the research conducted at Capital Health. When investigator-initiated trials involve a drug or natural Health Canada requires all investigators, sub-investigators ... View Full Source

Health Products And Food Branch Inspectorate Holland Cross ...
Health Products and Food Branch Inspectorate INSPECTION STRATEGY FOR CLINICAL TRIALS January 15, 2002 Page 3 of 8 CONTENTS 1. PURPOSE 2. BACKGROUND ... Access Doc

Health Canada: Clinical Trial Inspection Planning
Health Canada: Clinical Trial Inspection Planning GCP Information Sessions November 2010 . – Number of clinical trials conducted at the site Health Canada Drugs and Health Products ... Read Here

Medicare Is Cracking Down On Who Has To Pay For Clinical ...
Medicare Is Cracking Down On Who Has To Pay For Clinical Trial Related Injuries and Complications http://www.theclinicaltrialsguru.com. ... View Video

Northern Alberta Clinical Trials And Research Centre
Northern Alberta Clinical Trials and Research Centre “NACTRC News” Fall 2006 Vol. 3 Issue 2 Page 1 of 8 M C D Health Canada Me esssa agge ffr ro omm tthhe BBoardd ... Fetch Content