Study Site Standard Operating Proceedures
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Study Site Standard Operating Procedures
Authors: Johan PE Karlberg and Selene Tam
Published by: Clinical Trial Magnifier Limited
Published: 2011. Revised 2014
Study sites that have well-written, comprehensive and practical clinical research SOPs have a distinct advantage over those that do not.
Well-written SOPs are the most efficient way to train new staff and to ensure that they continue to work autonomously.
They ensure consistency, compliance and accountability of personnel. Sites without clinical research specific SOPs run a high risk of non-compliance as well as poor productivity.
You can download a full set (n=55) of site SOPs developed in collaboration with an international group of clinical trial professionals from this page.
Note: From April 2015 distributed by Clinical Trial Magnifier Limited only.
Tips and suggestions
❶ Download the Introduction, Contents, Contributors file and review.
❷ If you decide to use the SOPs, download the 55 SOPs as word files (zip file including all SOPs).
❸ Create your own site SOPs by revising the downloaded SOPs.
❹ Organize staff meetings (e.g. lunch); review and revise each SOPs (highly educational activity) together.
❺ Sign the completed SOPs and post them as pdf files on the intranet.
❻ Review and update the SOPs annually (staff meetings).
❼ Underline all changes made in the new versions and see that all staff knows about the changes.
❽ Keep previous SOP versions in an archive.
❾ News staff should read the SOPs and then discuss them with a senior staff member.
❿ Always inform sponsors and CROs that you have implemented the SOPs
Maria AGCAOILI, JD, BN, CEO/Founder, Ascent Pharma Solutions Inc, Jersey City, New Jersey/Taguig, Metro Manila, Philippines
Bhawarlal ANANDAKUMAR, MBBS, PG DHSc, Co-investigator, Clinical Trials, Swamy Diabetes, Chennai, India
Joel M. BARRA, BSBM, CCRP, Director, Clinical Operations, American Institute of Research, Whittier, California, USA
Pauline CARR, MA, MBL, Head of Operations, Medicine, Boehringer Ingelheim South Africa, Johannesburg, South Africa
Karina CHUI, BN, Clinical Trials Coordinator, St George Hospital, New South Wales, Australia
Wesley CORREA, BSc, Clinical Project Leader, sanofi-aventis pharmaceutical, Sao Paulo, Brazil
Diane DAVIES, Senior Pharmacist Clinical Trials, Pharmacy Department, Prince of Wales Hospital, Randwick, Australia
Linda R. DAVRATH, PhD, MSc, Director, Clinical Research, Biological Signal Processing, Tel Aviv, Israel
Victoria DWYER DIBIASO, MPH, RN, Head of Protocol Feasibility & Patient Enrollment, genzyme, Cambridge, Massachusetts, USA
Frank F. FAN, MD, MBA, Medical Affairs, Medical Department, Wyeth Pharmaceutical Co, Ltd, Hong Kong, PR China
Pedro R. GARGOLOFF, MD, Departamento de Investigacion Clinica, Clinica Santa Teresa de Avila, La Plata, Argentina
Melanie G. GENTGALL, RN, CCRC, Clinical Research Manager, Pain and Anaesthesia Research Clinic, University of Adelaide, Adelaide, Australia
Stefan GLÜCK, MD, PhD, FRCPC, Sylvester Professor, Department of Medicine, University of Miami, Florida, USA
Markus HARTMANN, PhD, MDRA, European Consulting and Contracting in Oncology, Trier, Germany
Ximena ILLARRAMENDI, MD, PhD, Leprosy Laboratory, Oswaldo Cruz Institute, FIOCRUZ, Rio de Janeiro, Brazil
Theresa JACOB, BS, MS, PhD, MPH, Director, Clinical Trials Unit & Translational Research, Maimonides Medical Center, Brooklyn, USA
Lais C.W. KOELLE, MPharm, MBA, Director, Clinical Operations, Medpace, Sao Paulo, Brazil
Dr. Boleslav L. LICHTERMAN, MD, PhD, Senior Researcher, Russian Academy of Medical Sciences, Moscow, Russia
Annie LIN, BSc, Senior Clinical Research Coordinator, Clinical Trials Centre, The University of Hong Kong, Hong Kong, PR China
Peter MARKS, MSc, BSc, Head of Metrics, Analysis and Reporting, Quality Assurance, Pfizer Limited, Sandwich, UK
Essack MITHA, MBChB, Dip Obstetrics, Principal Investigator, Newtown Clinical Research Centre, Johannesburg, South Africa
Sivagnanam NALLAPERUMAL, MD, Dip Diabetes, Consultant Diabetologist, Swamy Diabetes Centre, Chennai, India
Shiva Murthy NANJUNDAPPA, MBBS, MD, Director, Clinical Research and Business Development, Quartesian Clinical Research Pvt Ltd, Bangalore, India
Elizabeth L.Y. NG, BA, Publishing Assistant, Clinical Trials Centre, The University of Hong Kong, Hong Kong, PR China
Yelena NOVIK, MD, Medical Director, Clinical Trials Unit & Translational Research, Cancer Institute, New York University School of Medicine, New York, USA
Carlo PETRINI, PhD, Senior Researcher, Bioethics Unit, Office of the President, National Institute of Health, Rome, Italy
Torben PLESNER, MD, PhD, Professor, Institute of Regional Health Science & Department of Hematology/Internal Medicine, University of Southern Denmark, Denmark
Dimple D. RAJGOR, MSc, Research Associate, HSSR, Duke-NUS Graduate Medical School, Singapore
Raja' SAMMOUR, MSc, Research Support Services Manager, Office of Clinical Research and Cancer Registry, King Hussein Cancer Center, Amman, Jordan
Sandra L. SCHNEIDER, EMBA, DrPH, CEO, Research & Clinical Laboratory Systems, Helotes, Texas, USA
Radulovic S. SINISA, MD, PhD, Scientific Director, Institute for Oncology and Radiology of Serbia, National Cancer Research Center, Belgrade, Serbia
Sujatha SRIDHAR, MBBS, MCE, CIP, Director, Clinical Trials Resource Center, University of Texas Health Science Center, Houston, Texas, USA
Raquel L.R. TEIXEIRA, PhD, Program Manager, GCP Compliance, Al Clinical Field Operations, Medical Division, Abbott, Quebec, Canada
Cindy WABNER, PhD, Clinical Research Coordinator, Springs Medical Research, LLC, Owensboro, USA
Azeem H. WALELE, MBCHB, FCPAED, Head, Department of Paediatrics, SA National Military Health Services, Cape Town, South Africa
Beat E. WIDLER, PhD, Global Head, Clinical Quality, F. Hoffmann-La Roche Ltd, Basel, Switzerland
Torben Plesner, MD: Professor of Hematology, University of Southern Denmark, Internal Medicine, Vejle Hospital, Vejle, Denmark. The comprehensive collection of documents describing Standard Operating Procedures for the conduct of clinical trials that is now offered free of charge from the home page of Clinical Trial Magnifier was originally developed by Professor Johan Karlberg and his team at the Clinical Trials Center, University of Hong Kong. In preparing the SOPs Dr. Karlberg and his team could draw upon their extensive experience from over a decade of conducting clinical trials and assisting other teams in this enterprise. Dr. Karlberg is a highly recognized international expert in all important aspects of clinical research. He and his team generously provided the SOPs for our use a few years ago, and they have now been implemented as a national standard for all the Clinical Trial Units at the Departments of Hematology in Denmark. In this process minor adjustments were needed to adapt to special national conditions and local needs but the frame and content of the SOPs as provided by Dr. Karlberg has greatly facilitated the final shaping and implementation of these very useful tools. Our interaction with Sponsors of clinical trials, be it pharmaceutical companies or Sponsor-investigators, is much easier now with these important documents at hand.
Anonymous, MD, PhD: I just want to congratulate the authors to a comprehensive and excellent set of site SOPs. We have implemented the SOPs at our site and that has significantly improved our performance. Sponsors and CROs who have audited our site have all been impressed by the SOPs.
Study Site Standard Operating Procedures: Staff SOPs - Generic (8 SOPs)
Study Site Standard Operating Procedures: Quality Assurance SOPs - Generic (11 SOPs)
Study Site Standard Operating Procedures: Pre-Study SOPs - Study Specific
- SOP P1 Pre-Study Visit
SOP P2 Review of Protocol
SOP P3 Review of Protocol Amendments
SOP P4 Review of Investigator’s Brochure
SOP P5 Review of Case Report Form (CRF)
SOP P6 Study Organization and Planning
SOP P7 Study Team - Definition of Responsibility
SOP P8 Recruitment of Subjects
SOP P9 Pre-Study Planning of Investigational Products
SOP P10 Pre-Study Planning for Laboratory Investigations
SOP P11 Investigators’ Meeting and Good Clinical Practice Training
SOP P12 Ethics Committee or Institutional Review Board Application and Communications
SOP P13 Regulatory Authority Applications and Documents
SOP P14 Vulnerable Subjects
Study Site Standard Operating Procedures: Trial Operation SOPs - Study Specific (18 SOPs)
Study Site Standard Operating Procedures: Study Closure SOPs - Study Specific (4 SOPs)