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ACRC Glossary Common Terminology

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ACRC Glossary Common Terminology jia Glossary and Version 3.0 Common May 2017 Terminology Speaking the Same Language Introduction Developing streamlined province-wide processes requires the use of For the latest version, consistent terminology. Visit the ACRC Webpage at: The glossary and common terminology: http://www.aihealthsolutions • Includes acronyms and classification systems .ca/initiatives- • Improves communication by ensuring shared understanding of partnerships/acrc-alberta- concepts for discussion and measurement clinical-research-consortium/ • Improves clarity and reduces delays by avoiding confusion and misunderstanding The common terminology is integrated into the ACRC processes, tools, templates, and training opportunities. Clinical researchers, service departments, study staff, and institutions are encouraged to adopt the terminology. This glossary is part of the ACRC strategic priority #3 to “develop provincial ACRC Partner standards and opportunities for clinical research training”. It contributes to Organizations a set of tools and training opportunities which incorporate best practices and applicable guidelines, created by the ACRC. Through these efforts, it is Alberta Health Services anticipated that the quality and efficiency of clinical research in the province Alberta Innovates will be enhanced. College of Physicians & Surgeons of Alberta Alberta Clinical Research Consortium (ACRC) Covenant Health The ACRC is a provincial initiative that involves academic and community- University of Alberta based researchers and administrators working together to achieve the vision of “high quality, integrated and efficient clinical research in Alberta”. University of Calgary From study start-up to close in all phases and disease areas, the ACRC is simplifying and harmonizing administrative processes across the province. High quality clinical research standards are upheld through the incorporation of best practices and applicable guidelines. The goal is to enhance quality clinical research that will improve patient outcomes in the province. ACRC Glossary & Common Terminology Version 3.0 ©Alberta Innovates Suite 1500, 10104 - 103 Ave NW Edmonton, Alberta, Canada T5J 0H8 Phone: 1-877-423-5727 Fax: (780) 429-3509 ISBN (Print): 978-1-894927-85-7 ISBN (Online): 978-1-894927-86-4 1 May 2017 Funding provided by: The Alberta Clinical Research Consortium Page 2 May 1, 2017 ACRC Glossary & Common Terminology Version 3.0 TABLE OF CONTENTS Table of Contents ..................................................................................................... 3 Method .................................................................................................................... 4 Acknowledgements ................................................................................................. 4 Acronyms ................................................................................................................. 5 ORGANIZATIONS ......................................................................................................................................................... 5 TERMS ......................................................................................................................................................................... 6 Classification ............................................................................................................ 8 CIHR CATEGORIES OF RESEARCH ................................................................................................................................. 8 STUDY ORIGINS ........................................................................................................................................................... 8 FUNDING SOURCES ..................................................................................................................................................... 8 PHASES OF CLINICAL RESEARCH .................................................................................................................................. 8 METHODS OF RESEARCH ............................................................................................................................................. 8 STUDY PHASES ............................................................................................................................................................. 8 STUDY STATUSES ......................................................................................................................................................... 8 PARTICIPANT STATUSES .............................................................................................................................................. 8 TYPES OF INVESTIGATOR / RESEARCH ROLES ............................................................................................................. 8 STUDY DESIGNS ........................................................................................................................................................... 8 Alberta-specific Terminology ................................................................................... 9 DEFINITIONS FOR CLINICAL (HEALTH) RESEARCH ....................................................................................................... 9 ADMINISTRATIVE DEFINITION FOR CLINICAL (HEALTH) RESEARCH ............................................................................ 9 DETERMINING WHETHER YOUR QI OR PROGRAM EVALUATION STUDY HAS A CLINICAL (HEALTH) RESEARCH COMPONENT ............................................................................................................................................................. 10 PARTICIPANT VERSUS SUBJECT ................................................................................................................................. 10 Glossary ................................................................................................................. 11 Bibliography ........................................................................................................... 61 TABLE 1: COMPARISON OF CLINICAL RESEARCH AND TRIAL DEFINITIONS ............................................................... 62 The Alberta Clinical Research Consortium Page 3 May 1, 2017 ACRC Glossary & Common Terminology Version 3.0 METHOD The Glossary and Common Terminology is developed from existing documents and primary sources (ie. TCPS2, Health Canada, FDA). The Strategic Priority #3 - Glossary and Common Terminology Working Group reviews each term in consultation with the ACRC partner organizations. Terms are defined, and where necessary refined, to the Alberta context. The Glossary is reviewed annually and revised as necessary. Occasionally there are changes in terminology, names of committees, groups, etc. Terms no longer in use will refer to the new term for a period of one year, after which the old term will be removed. Please submit comments to [email protected]. ACKNOWLEDGEMENTS The ACRC gratefully acknowledges the assistance of the Strategic Priority #3 – Glossary and Common Terminology Working Group: Mary-Ann Clarkes (Covenant Health/CHRC); Ronda Danchak (AI/ACRC); Troy Hamilton (The Bailey Clinic); Trina Johnson (AI/ACRC); Tammy Mah-Fraser (AI/ACRC). Additionally, Lori Anderson, Liza Chan, Marilyn David, Mary Hodges, Audrey Hollingshead, Scott Jamieson, Lissa Jutras, Nicky Kopac, Shane Lacusta, Carlos Miranda, Rachel Syme and Elizabeth Watts. ACRC Related Resources & Websites: The ACRC The Inaugural Strategic Plan Consultation (2011) The ACRC Inaugural Strategic Plan (2012) Strategic Plan At-A-Glance 2012-2013 ACRC Research Toolbox CITI-Canada Training and CITI-Training ACRC Instruction Manual The Alberta Clinical Research Consortium Page 4 May 1, 2017 ACRC Glossary & Common Terminology Version 3.0 ACRONYMS ORGANIZATIONS AbSPORU Alberta SPOR Support Unit EC European Commission ACCT Alberta Cancer Clinical Trials EMA/EMEA European Medicines Agency ACRC Alberta Clinical Research Consortium EU European Union ACHRI Alberta Children’s Hospital Research FDA Food & Drug Administration (US) Institute GoA Government of Alberta ACRO Association of Clinical Research HC (SC) Health Canada / Santé Canada Organizations HPFB Health Products & Food Branch ACRP Association of Clinical Research HPFBI Health Products & Food Branch Professionals Inspectorate AH Alberta Health HREB Health Research Ethics Board (AHS, AHRQ Agency for Healthcare Research & Covenant Health, UofA) Quality HREBA Health Research Ethics Board of AHS Alberta Health Services Alberta AI Alberta Innovates HREBA-CC Health Research Ethics Board of ANSI American National Standards Institute Alberta-Cancer Committee APCR Academy of Physicians in Clinical HREBA-CHC Health Research Ethics Board of Research Alberta- Community Health ARECCI Alberta Research Ethics Community Committee Consensus Initiative HREBA-CTC Health Research Ethics Board of AU Athabasca University Alberta- Clinical Trials Committee BGTD Biologics and Genetic Therapies HREH Health Research Ethics Harmonization Directorate initiative CASRAI Consortia Advancing Standards in IATA International Air Transportation Research Administration Information Association CCCR Calgary Centre for Clinical Research ISO International Organization for CDC Centers for Disease Control and Standardization Prevention (US) MHRA Medicines and Healthcare Products CDISC Clinical Data Interchange Standards Regulatory Agency Consortium N2 Network of Networks CHLA Canadian Health Libraries
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