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Clinical Researcher OCTOBER 2017 12 Getting on Board with ICH GCP E6(R2) 26 New European Medical Device Regulation 32 Clinical Trial Operations: Who is Watching? The Authority in Ethical, Responsible Clinical Research Regulations and Compliance: The Climb is Worth It See page 8 for exciting news about our next issue… Association of Clinical Research Professionals (ACRP) Professionals Research of Clinical Association www.acrpnet.org 10-Week CRA & CRC Beginner Program Meet The online 10-Week CRA & CRC Beginner Program provides a comprehensive introduction to clinical research and the job functions of the Clinical Research Associate (CRA) and Clinical Research Coordinator (CRC) for drug, biologic, and device trials. This program is geared toward individuals seeking a new career or career change into clinical research, Felix but haven’t decided which job track to pursue. Case studies and industry best practices are presented to emphasize how the learning objectives apply directly to the responsibilities of the CRA and CRC. Upon completion, Barnett will provide resume assistance so that you can position yourself for entry into this market. 2 years of service 31,526 miles traveled 3 countries of former residence Welcome to a different kind of CRO. rhoworld.com/careers BarnettInternational.com Customer Service: 800.856.2556 Meet Felix 2 years of service 31,526 miles traveled 3 countries of former residence Welcome to a different kind of CRO. rhoworld.com/careers CONTENTS October 2017 • Volume 31, Issue 5 • ISSN 2334-1882 6 Feature PEER REVIEWED GUEST EDITOR’S MESSAGE Regulations and Compliance: The Climb is Worth It Glenda Guest, CCRA, RQAP-GCP, TIACR Clinical Researcher is your platform. Interested in writing Columns a peer-reviewed article 8 EXECUTIVE DIRECTOR’S or guest column? You’ll MESSAGE find our submissions 10 CHAIR’S MESSAGE 12 26 38 Getting on Board with The New European A Mixed Method guidelines at 18 CAREERS— PASSING IT ON ICH GCP E6(R2): Medical Device Approach to Assessing acrpnet.org/submit Impact on Study Regulation 2017/745: Good Clinical Practice 24 ICH IN FOCUS Quality and Main Changes and Computerized Online 30 OPERATING Operations Challenges Learning ASSUMPTIONS Jan S. Peterson, MS, CCRA, RAC, MICR, Norbert Clemens, MD, PhD, CPI Linda S. Behar-Horenstein, PhD; 50 RESEARCH ASQ CBA Wajeeh Bajwa, PhD; COMPLIANCE H. Robert Kolb, RN, CCRC; Alena Prikhidko Home Study 56 INFORMATION EARN 3.0 20 CREDITS Medical Devices IN THIS ISSUE Research in Latin 32 OF CLINICAL America Blind Spot in Clinical Trial Operations: Who 44 RESEARCHER Miguel A. Willis, PhD; OPINION: The Role Anne Blanchard, CCRA is Watching? of Certification in Clinical Researcher ISSN 2334-1882 Nadina Jose, MD; (Print) and ISSN 2334-1890 (Online) Roshan Padbidri, MS; Developing a Quality is published bimonthly. It is provided Suzette Cody, MA Clinical Workforce to ACRP members by the Association Kelly M. Cairns, MA, BASc, APRM, CCRA of Clinical Research Professionals Workforce (ACRP). The views, research methods, and conclusions expressed in material Innovation Also in This Issue published in Clinical Researcher are those of the individual author(s) and not necessarily those of ACRP. © Copyright 2017 Association of 52 Clinical Research Professionals. All rights reserved. For permission to ACRP’s Career photocopy or use material published Development herein, contact www.copyright.com. For other information, write to editor@ Resources—Looking acrpnet.org. Beyond Competency Postmaster: Send address changes to Development Clinical Researcher Beth D. Harper, BSOT, MBA 99 Canal Center Plaza, Suite 200, Alexandria, VA 22314 +1.703.254.8102 (fax) 54 +1.703.254.8100 (phone) www.acrpnet.org On the CRbeat: The 4 17 48 Latest News from the IN MEMORIAM MEMBER PROFILE MEMBER PROFILE World of Workforce Margaret F. Fay, PhD, Christina L. Nance, Shirley Trainor- DESIGN Innovation RN, CCRC PhD, CPI, FAACI Thomas, MHSA TGD Communications tgdcom.com October 2017 2 Clinical Researcher IN MEMORIAM EDITOR-IN-CHIEF James Michael Causey [email protected] (703) 253-6274 MANAGING EDITOR Gary W. Cramer (703) 258-3504 EDITORIAL ADVISORY BOARD CHAIR Jerry Stein, PhD Summer Creek Consulting LLC VICE CHAIR Paula Smailes, RN, MSN, CCRC, CCRP The Ohio State University Wexner Medical Center ACRP Mourns Passing of ASSOCIATION BOARD OF TRUSTEES LIAISON Margaret F. Fay, PhD, RN, CCRC, Ernest Prentice, PhD Board of Trustees Member University of Nebraska Medical Center TRAINING AND DEVELOPMENT COMMITTEE LIAISON Suheila Abdul-Karrim, CCRA, CCRT The Association of Clinical Research Professionals (ACRP) Freelancer was saddened by the passing in August of Margaret (“Peggy”) Victor Chen F. Fay, PhD, RN, CCRC, Board of Trustees Member. The C and K Clinical Group Dr. Fay was appointed to the Association Board of Trust- Fraser Gibson ees in June 2016. She was also the 2015 recipient of ACRP’s Advantage Clinical Innovation in Clinical Research Award. Gregory Hale, MD, CPI “Peggy was a pioneer in the world of clinical research All Children’s Hospital and was personally dedicated to ACRP’s mission,” said ACRP Stuart Horowitz, PhD, MBA WIRB-Copernicus Group Executive Director Jim Kremidas. “Her creativity and exper- Stefanie La Manna, PhD, ARNP, FNP-C tise were assets to our Board of Trustees. She will be missed Nova Southeastern University by the industry and the many who loved her.” Jamie Meseke, MSM, CCRA Dr. Fay has more than 38 years of progressive research PPD, Inc. and management experience in academic, hospital, corpo- Christina Nance rate, and independently owned research site organizations. Baylor College of Medicine She served as a clinical study coordinator, an auditor for Grannum Sant, MD, BCh, BAO (Hons.), MA, FRCS, FACS Tufts University School of Medicine human and animal research, a clinical research associate, Shirley Trainor-Thomas medical liaison, site director, and researcher. GuideStar Clinical Trials Management In her most recent role as Global Director, Clinical Heather Wright Research Monitor for Medtronic, Peggy was responsible for Tampa Bay Clinical Research Center 220 research professionals serving 10 individual businesses, and more than 400 clinical trials across the globe. She was a ADVERTISING consultant to the research industry and served as an advisor, Tammy B. Workman, CEM Director, Advertising & Exhibition Sales content expert, and medical writer for various pharmaceuti- (703) 254-8112 cal and medical device companies. She is the inventor of four [email protected] patents, two in the area of micro current technology and two For membership questions, contact ACRP at in the field of risk-based clinical trial conduct. [email protected] or (703) 254-8100 October 2017 4 Clinical Researcher ARE YOU READY FOR AN ADVERSE REACTION? STAT KITs include medications and devices to treat a variety of medical emergencies. STAT KIT ® 550 emergency medical kit for basic emergencies, including BLS and anaphylaxis STAT KIT ® Z-1000 emergency medical kit for advanced emergencies, including ACLS and advanced airway Call or visit to nd the right emergency medical kit for you. Life-Saving Equipment, Medications & Training StatKit.com | 888.782.8548 9633 v.001, 09/2017 GUEST EDITOR’S MESSAGE Glenda Guest, CCRA, RQAP-GCP, TIACR [DOI: 10.14524/CR-17-4039] Regulations and Compliance: The Climb is Worth It I admit it. Over the span of more than 20 years as a clinical research professional, I have become what I affectionately refer to as a “Regulatory Geek.” While I learned the criticality of compliance with regulatory requirements early in my career as a research monitor, my appreciation and understanding of the concept evolved as I progressed through the ranks to my current role, which is focused on specialty auditing and advanced training. My volunteer efforts on behalf of the clinical research enterprise via my involvement with ACRP have also broadened my regulatory perspective. I believe that there When I joined ACRP’s Regulatory Affairs Com- fields not necessary for our product—rather than mittee several years ago, I had no idea how much it requiring sites/monitors/data management teams are more similarities would impact my career and my desire to see global to accommodate slight study-specific differences than differences in the regulatory harmonization become a reality. Those with a completely different layout and form for each who know me via my volunteer efforts for ACRP rec- type of product and each sponsor? conduct of research, ognize my passion for standardization and harmo- Adoption of a standard form, with some fields whether it is a drug nization. I believe that there are more similarities “not applicable” for certain studies, would very likely than differences in the conduct of research, whether foster greater accuracy, less missing data, and fewer or a device product, it is a drug or a device product, or a U.S.-based study queries, which equates to saved time and costs asso- versus one conducted outside the U.S. Embracing ciated with query resolution. Even if the industry or a U.S.-based study this assumption enables one to focus on the critical were to accept just two such CRFs (Drug Concomi- versus one conducted differences, while maximizing the similarities via tant Medications and Device Concomitant Medica- efforts at standardization and harmonization. tions), it would be a step in the right direction. outside the U.S. Seeing these efforts through to completion in the As the world becomes a more global market- form of regulations and compliance expectations place, it seems logical to me that harmonization of that benefit the entirety of our global enterprise can global regulatory requirements would be a natural often seem like a long and uphill struggle, but the evolution, as well. Cross-country acceptance of climb is worth it. product approval data with fewer requirements for “country-specific” studies, other than those In Search of Harmony designed to address population-specific product interactions, could reduce burdens on both industry One arena in which to observe this could be the and regulatory authorities around the globe.
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