2014 Annual Report Quality Education Peer Recognition Clinical Research Certification Society of Clinical Research Associates Table of Contents Welcome from the Board of Directors 3 Mission and Introduction 4 History and the Future 5 Certification for Clinical Research Professionals “CCRP®” 6 Annual Conference 8 Education Overview 10 Online Education 10 Clinical Investigator GCP and Trials Management Conference 11 2 Quality Improvement Through Standard Operating Procedures 15 Harnessing Social Media to Advance Clinical Research 15 Clinical Trial Management Systems (CTMS) Conference 15 FDA Clinical Trial Requirements and GCP Conference 16 Conducting Clinical Trials in Canada 16 Clinical Research Project / Program Management Conference 17 11 Protecting Human Research Participants: Legal, Ethical and Practical Considerations 17 12 Device Research and Regulatory Conference 18 Advanced Site Management: Finance and Productivity 12 Pediatric Clinical Trials Conference 18 Clinical Science Course 13 Chapter Development 19 Certification Preparation and Review Course 13 Board of Directors Directory 20 Member Resources 14 Management Directory 22 Executive Director’s Report 23 2014-2015 Calendar of Events 24 Clinical Research Monitoring and GCP Workshop Clinical Site Coordinator / Manager Workshop SOC R A A NNUA L REP ORT 2014 I thank our hundreds of speakers, exhibitors, advertisers, and chapter and Board member volunteers who contribute to the improvement of health for people around our world. Wendy Lloyd, BA, LPN, CIP, CCRP President 2013-2014 Dear Colleagues in Clinical Research: I am pleased to advise you that and other researchers by allowing committee members and the credentials. See page 10 for details. The examination is scheduled at them to maintain their licenses and the Society of Clinical Research Included in this annual report are membership of over 15,000 clinical programs (conferences, workshops Associates (SOCRA) has achieved a research professionals. With 70% of our members certified, and all members striving to improve clinical research protections and research outcomes, we are assured that SOCRA is benefitting the research community, the millions of research subjects who support the overviews of the SOCRA education and training programs) available implemented its first conference dedicated to pediatric research in 2014. Additional program are in development at this time. We are sincerely proud of our conferences and education programs. and Japan. variety of content, as well as a poster exchange of information, peer to peer conversation, and personal connection with industry experts. researchers may apply for SOCRA the research professional. SOCRA as well as Saudi Arabia, Singapore, for networking, discussion, science and research. education programs to support 2014 throughout the US and Canada, Our annual conference offers eight These programs offer opportunities development of medical care, and all We continue to develop new 94 different venues in the year to the clinical research community. As a result of their experience patients worldwide who benefit from staff who support the program. and education, qualified clinical certification as certified clinical research professionals. Our tracks (100+ speakers) with a large and exhibit program. If you have attended as a participant in the past, please consider becoming more involved by submitting a poster or presenting at the annual conference. The conference will be held in Denver, CO in 2015; Montreal, QC in 2016; and Orlando, FL in 2017. certification program recognizes We continue to encourage excellence and ability to apply clinical research our new logo and on our new web an individual’s understanding of, regulations and guidance within the realm of medical research. Certification recognizes the candidate’s dedication to quality research and to the protection of research subjects. They understand SOCRA education is accredited by the clinical research policies, medical education for physicians, and pertaining to best practices, of continuing nurse education by the safety. We hold this program in nurses, physicians, pharmacists volunteer certification program the ACCME to provide continuing procedures, rules, and regulations SOCRA is an accredited as a provider operating procedures, and subject ANCC. These accreditations benefit high esteem and are proud of our in clinical research, as displayed in site, in addition to our education and certification programs. I encourage your participation and greater involvement in SOCRA activities, including chapter activities and speaking opportunities. Sincerely, Wendy Lloyd, BA, LPN, CIP, CCRP President, SOCRA Board of Directors VIS IT WWW.S OCRA.ORG 3 INTRODUCTION and HISTORY MISSION In order to promote quality clinical research, protect the welfare of research participants, and improve global health, SOCRA’s mission is: To establish educational To establish an internationally To foster the professional continuing education for program for clinical research recognition of clinical programming and provide clinical research professionals. recognized certification professionals (CCRP®). development and peer research professionals Introduction The Society of Clinical Research Associates (SOCRA) is The most important factors in our success over the organization committed to providing education, educational programming and our certification program. a non-profit, charitable and educational membership certification, and networking opportunities to all persons involved in clinical research activities. SOCRA began as the premier educational organization for oncology site coordinators and has emerged as a leading educational organization for clinical researchers in all therapeutic areas, supporting industry, government and academia. Since incorporation in 1991, SOCRA has been through many changes, all of which were important contributors to our growth. The lack of available educational opportunities for site based coordinators and the thirst for information resulted in an organization founded by creative and forward thinking leaders. Today, the organization has realized membership growth and past years have been our membership support, our Innovation and investment of skill and knowledge have resulted in an exceptional organization with expertise and understanding in providing educational programming and member services. The quality of our programs and educators is unparalleled. Our educational programming has been wonderfully successful as has our certification program and our noteworthy Annual Conference. We are committed to devoting a tremendous effort to developing and providing new and innovative approaches to learning. We intend to explore new educational opportunities and to maximize those opportunities for future success. program expansion exceeding its expectations. Membership Demographics 5% IRB / Ethics Boards 30% Industry 5% Other Areas of Research 60% Investigational Sites 15,165 members as of August 15, 2014 Our worldwide membership includes members from the U.S.A., Canada, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Cayman Islands, Chile, China-SAR, Colombia, Costa Rica, Denmark, Egypt, France, Germany, Greece, India, Ireland, Jamaica, Japan, Lebanon, Malaysia, Mexico, Netherlands, Nigeria, Philippines, Portugal, Puerto Rico, Qatar, Russia, Saudi Arabia, Scotland, Singapore, South Africa, South Korea, Switzerland, Thailand, UAE, Uganda, and United Kingdom. 4 SOC R A A NNUA L REP ORT 2014 A BRIEF HISTORY OF SOCRA As you review this list of accomplishments you will see that our mission to develop meaningful education for our members continues to be in the forefront of our activities. SOCRA has again made important strides in offering educational opportunities. 1991 SOCRA Founded (June) and Incorporated (October) 1992 First Annual Conference First Certification Examination (CCRP) 1995 1996 Clinical Science Course offered Chapter Program begun Annual Conference workshop on Statistics in Clinical Research 2009 Annual Conference workshop on Device Research Clinical Investigator Training Course offered 2010 Awarded Accreditation with Commendation as a provider of physician CME by ACCME 2000 Clinical Research Monitoring Workshop developed 2001 Certification Preparation & Review Course offered Chapter Chairperson Recognition Award first presented 2002 Awarded ANA/ANCC providership for Nurse CNE Project / Program Management Conference offered 2003 Japanese Language Certification examination offered 2011 Online training courses offered Annual Conference workshop on Project Management Site Symposium for Coordinators, Associates, Nurses offered Clinical Trial Management System (CTMS) Conference offered FDA Clinical Trial Regulations Conference series begun 2012 Completed / published Task Analysis survey of clinical research activities French Language Certification exam offered Instituted option for Peer Review of SOCRA SOURCE journal articles French Language Prep Course offered 2005 SOP for Senior Site Managers workshop offered 2013 Conducting Clinical Trials in Canada Conference offered Salary Survey for Clinical Researchers Published 2006 First annual Device Clinical Research Conference Advanced Site Management/ Finance Workshop offered First on line basic GCP course (through CITI program) 1999 Human Research Protections Program begun 2004 2008 Approved as a provider of physician CME by ACCME Social Media in Clinical Research Conference offered 2007 Annual Conference workshops added on Research Law, Protocol Development, and Grant Writing 2014 Pediatric Clinical Research Conference offered THE FUTURE SOCRA promises to provide continued educational programming that will offer the most current information available to the clinical researcher. Clinical research professionals and other experts working in the clinical research arena will deliver courses. Our education programs offer high levels of participation and great overall satisfaction. Our certification program offers many testing dates and locations, with 94 testing opportunities scheduled in 2014. For all our enthusiasm, we remain realistic about the changing work environment and current economic conditions. We will continue to work towards innovative programming and technologies to benefit our members in cost effective ways. VIS IT WWW.S OCRA.ORG 5 CERTIFIED CLINICAL RESEARCH PROFESSIONAL CERTIFICATION “CCRP®” PROGRAM Why Certification? Exam Description Program for Currently more than 10,000 certified! Professionals in 94 exam sites hosted in practice. The case studies are an internationally Singapore and Saudi Arabia SOCRA established the Certification Clinical Research order to create Donna Headlee, RN, BSN, CCRP Program Chairperson, Certification accepted standard the USA, Canada, Japan, of knowledge, in 2014 experience by 2,166 candidates tested* education, and which clinical research professionals will be recognized by the clinical 83% passed exam* individuals so approved may use 2,170 CCRPs recertified* research community. Those the title “Certified Clinical Research Professional” or “CCRP®” * based on May 2013- May 2014 data The Certified Clinical Research CCRP Examination Content is intended to evaluate a CRP’s examination is organized into Scope multiple choice questions. The examination contains case studies that relate to clinical research intended to evaluate a candidate’s ability to abstract data and do not require clinical experience. The questions are formulated to be straight-forward and easily understood. Each question is weighted equally. The certification examination is offered in the English language. Exam Scoring The 135 question exam consists of 130 scored questions and five (5) unscored questions. SOCRA collects data on unscored test items to assure that the questions are clear, concise Professional Certification program The CCRP® certification knowledge, understanding, and five major subject areas. in future exams as scored items. Five Subject Areas and Percent of Test Items in Each Area 102 out of 130 scored items in application of the conduct of clinical investigations involving humans in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice (E6) (ICH/GCP), ICH Clinical Safety • Ethical Principles / Informed Standards for Expedited Reporting • Institutional Review Board / Data Management: Definitions and (E2A), the United States Code of Federal Regulations (CFR) Parts 11, 50, 56, 312, 812 and the ethical principles that guide clinical research consistent with the principles of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. Consent / Safety = 20% - 25% and understandable before appearing Examinees must correctly answer order to achieve a passing score. The passing score is determined by a panel of experts and validated using a psychometric and statistical analysis. Institutional Ethics Committee Exam Validation Responsibilities = 7% - 11% psychometrically validated by (IRB/IEC) Roles and • Clinical Trial Protocol and Protocol Amendments = 4% - 8% • Investigator Roles and Responsibilities = 28% - 32% • Sponsor Roles and Responsibilities = 31% - 35% 6 The examination is made up of SOC R A A NNUA L REP ORT 2014 The exam is statistically and an independent consultant. The Certification Committee evaluates the results from the statistical/ psychometric evaluations and updates the exam, as needed. Candidate Eligibility Maintaining your Certification In order to be considered for SOCRA certification, the The CCRP credential is awarded in three year increments. EC/REB approved (or specifically exempted) protocols SOCRA is based on a continuing process of professional applicant must be working with GCP guidelines under IRB/ SOCRA will not be able to consider candidates who Certification of Clinical Research Professionals by experience and education. This program is intended are unable to provide the supporting documentation requested regarding their clinical research experience. to provide recognition and validation of the continued professional growth of the individual CCRP®. Minimum Experience Maintenance of Membership Continuous membership in SOCRA is required to maintain 1 year of full-time experience* as a Clinical 2 years of Research Professional within the past two full-time experience* as a OR years Clinical Research *equal to 1750 part-time hours Professional and and within the past five years Undergraduate Degree in *equal to 3500 or Graduate “Clinical part-time hours OR Certificate Research” from in “Clinical an Associate, Research” Undergraduate or Graduate Degree and Program* *Degree and Certificate Programs must meet requirements. Visit www.socra.org/certification for more details the CCRP credential. Continuing Education (CE) Requirement Certificants must complete 45 hours of CE during their three-year certification period. The breakdown of CE that may be claimed within each CE category follows: Minimum of Operations / claimed (no Research Regulatory Associate or Bachelor Degree in a science, health science, pharmacy or related field + Therapeutic / Professional Area + Recertification Quiz Application Portfolio 22 CE must be maximum) Total of 45 CE per 3-year NO minimum = certification period 1 CE may be claimed Only educational hours may be claimed for CE; you may The applicant must submit the following: not claim CE credit for your work hours. • Certification Application Recertification / Certification Renewal • Membership Application (or include member ID #) • Resume / CV To maintain active certification status, certificants must • Verification of Employment Letter apply for renewal of certification every three years. • Job Description(s) • Payment for the examination fee - $195 (US Funds) Clinical Those wishing to renew their CCRP certification must If applying using a degree or certificate program for eligibility purposes, appropriate forms and documentation (including transcripts) must be included (see website for details) successfully complete a re-certification quiz and provide documentation of 45 hours of validated CE credit. The fee for re-certification is currently $100. To A p p l y V i s i t w w w . s o c r a . o r g / c e r t i f i c a t i o n Applicants should thoroughly review all of the information provided in the Certification section of the website. Before submitting an application packet, applicants must review the eligibility requirements, application procedures and deadlines, and certification program policies and procedures. Candidates application and documentation must support the minimum work experience required. VIS IT WWW.S OCRA.ORG 7 Annual Conference The Annual Conference, held in Orlando, FL in 2014, features 100+ speakers presenting in 8 scholarly tracks - covering 21 different sessions/ Jody L. Green, PhD, CCRP Chair, 2014 Annual Conference topics. The conference also includes a robust exhibit and poster program. It offers a great way for clinical research professionals to meet their educational goals. 2 0 1 5 D enver , C O Sheraton Denver Downtown The year 2015 Annual Conference is scheduled for Denver, CO and The SOCRA Annual Conference has been enhanced and now includes eleven pre-conference workshops, plenary includes twelve pre-conference workshops and more than 110 sessions, break out sessions, an exhibit program, regulatory, technical and scientific and CME (Continuing Medical Education) Credit, sessions, exhibits, social events, posters sessions, and CNE (Continuing Nurse Education) all contributing to attendance growth and positive evaluations and testimonials. presentations, as well as poster a welcome reception, and an opportunity to participate in committee and planning meetings. Exhibit Program The Annual Conference exhibit program offers opportunities for attendees to stay up-to-date on current products and services offered to support clinical research programs in enhancing their effectiveness and productivity. The exhibit program is held on Friday and The 2016 Annual Conference will be held in Montréal, Québec Canada at the Palais des congrès de Montréal. Saturday, from 10am - 4pm. Poster Program The poster program offers an opportunity for members to share their research with interested colleagues. Posters offer information for viewers to understand the methods, results, and significance of the research, and to promote conversations and networking among conference participants. 8 SOC R A A NNUA L REP ORT 2014 2 0 1 6 M ontr é a l , Q u é bec Pa l a i s d e s c o n g rè s de Montréal 2013 Annual Conference In- Review The 22nd Annual Conference, titled Faces of Global Research: Compliance, Quality, Integrity, and Human Subjects Protection, was attended by more than 1,000 clinical research professionals. The conference featured scholarly presentations on topics such as Site Management, Ethics, Project Management, IRB, Academic Research, Oncology Research and more! 2013 President’s Award SOCRA presents a special recognition 2013 Chapter Chairperson Recognition award annually who has given President’s Award for outstanding service was Linda Higgins, CCRP. Ms. Higgins is the Manager, Regulatory and Clinical Research Affairs in the Scott Department of Urology at Baylor College of Medicine in Houston, TX. She served as a member of the SOCRA Board of Directors from 2002 to 2005 and was chapter chair of the Greater Houston SOCRA chapter from 2004 to 2010. She has presented for our SOP workshop since 2005. A current member of the certification committee, Ms. Higgins has served as the lead auditor for the re-certification program since 2004 and has proctored over 50 exams. We thank Ms. Higgins for her continued support of SOCRA. research in the two categories of granting the society. of the 2013 the chapter from the chapter service to the The recipient This program recognizes excellence chairperson exceptional Linda Higgins accepts the President’s Award at the 2013 Annual Conference in New Orleans SOCRA annually recognizes to an individual Dan Redline presents the Chapter Chairperson Award to Lyndsey Avery, BS, CCRP of the Arkansas Chapter 2013 Poster Program Special Recognition Award greatest amount of learning opportunity (SOCRA approved Continuing Education hours) to clinical research professionals. Lyndsey Avery, BS, CCRP of the SOCRA Arkansas Chapter, was in activities involved in clinical Clinical Trials and Clinical Research Management. The posters are evaluated by a group of experts in clinical research. The recipients demonstrate ability to present their work during the Annual Conference poster program. The special recognition awards for 2013 were presented to: Research Management Category Development of the Study Coordinator Apprenticeship and Mentoring Program (SCAMP) honored as the 2013 recipient of the Chapter Chairperson Award for awarding 29 CE hours to clinical research professionals between June 1, 2012 and May 31, 2013. Author: Stephanie Swords, MA, CCRP Johns Hopkins Institute for Clinical & Translational Research Clinical Trials Category Prevalence and Reproducibility of Masked Hypertension Among Primary Care Patients Author: Laura Tuttle, MA, CCRP University of North Carolina, Chapel Hill School of Medicine VIS IT WWW.S OCRA.ORG 9 SOCRA Education and Training The Importance of Training in the Conduct of Clinical Trials FDA Center for Drug Evaluation and Research (CDER) audit inspection findings from fiscal year 2006 through 2013 show trends in clinical investigator deficiencies in areas such as following protocol, record keeping and informed consent. SOCRA recognizes these trends and issues and offers education to clinical research professionals on Good Clinical Practice (GCP) and more. Our hope is that by participating in SOCRA programming, our members will be leaders in the clinical research profession and inspection findings will improve. ϱϬй ϰϱй ϰϬй ϮϬϬϳ ϯϱй ϮϬϬϴ ϯϬй ϮϬϬϵ Ϯϱй ϮϬϭϬ ϮϬй ϮϬϭϭ ϭϱй ϮϬϭϮ ϭϬй ϮϬϭϯ ϱй Ϭй WƌŽƚŽĐŽů ZĞĐŽƌĚƐ ƌƵŐĐĐƚ ŽŶƐĞŶƚ /Z Ɛ SOCRA is presently holding educational programs in the U.S.A., Canada, Mexico, Brazil, and Singapore. E ducation B rou g ht to you at the S ite In addition to our numerous offerings throughout the US and Canada, SOCRA will schedule the Certification Preparation and Review Course at your site for a minimum of 20 guaranteed participants. SOCRA can also customize our SOCRA OFFERS CME and CNE CNE for Nurses: Society of Clinical Research Associates is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation. CME for Physicians: The Society of Clinical Research Associates is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. educational offerings to meet the needs of your research site/ institution. ONLINE Training Programs SOCRA offers online learning in addition to the already robust array of live educational opportunities. The programs are offered as selfpaced on-demand presentations. A quiz following the presentation summarizes the topic and evaluates the participant’s understanding of the material. 10 SOCRA’s online courses provide any-time access to training and education for on-the-go clinical research professionals. SOC R A A NNUA L REP ORT 2014 Current offerings include: • GMP for Investigational New Drugs (IND) in Phase I Clinical Trials • What You Should Know Before the FDA Arrives • IND / IDE Assistance in an Academic Health Center - Why Provide IND/IDE Assistance? 2013 - 2014 Education Opportunities Clinical Investigator GCP & Trials Management Conference Clinical Research Monitoring and GCP Workshop For Monitors, Site Coordinators, and Auditors For Clinical Investigators and Key Research Staff This interactive workshop, for site monitors, managers or auditors with This course, for clinical investigators 0-5 years of experience, will review and key research staff, will review GCP, GCP and clinical research monitoring research finance and budgeting, and best practices. legal responsibilities of the clinical investigative site. Marie Falvo, CCRP Bausch & Lomb Co-Chairperson George D’Addamio, PhD PharmConsult, Inc. Program Committee and Faculty The purpose of this workshop is to assist has been a huge success in 2000. improving their skills and The program is offered two to three their understanding of times annually and is designed with the responsibilities of the ALL research professionals in mind. clinical research site. This program creates opportunity for dialogue among clinical investigators, Monitoring workshop since its implementation Clinical Investigators and key research staff in Carole SampsonLanders, MD Bayer HealthCare Pharmaceuticals Co-Chairperson The Clinical Research key research staff and program faculty. Jacqueline Busheikin, RN, CCRP Jana Research Corp. Program Committee and Faculty This workshop addresses the roles and responsibilities of a Clinical Research Associate / Monitor/ Auditor, and is also a great course for Research Study Coordinators who want to improve their understanding of the responsibilities The intent of which is to enhance the participants’ ability and interactions with Clinical Research Monitors. regulations and guidelines. This program is designed to The goal is accomplished through lecture and practical to perform quality clinical research according to existing address all of the functions of the research site related to the Good Clinical Practices as delineated by the U.S. Code of Federal Regulations and the guidelines supported by the ICH Guidelines. TransCelerate BioPharma: This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by application facilitated by clinical research professionals with a combined industry experience of more than 50 years. Information is presented and discussed regarding monitoring of clinical trials according to FDA Regulations and International Conference on Harmonisation (ICH) guidelines, as well as practical procedures and issues related to site / sponsor / CRO relationships. TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. VIS IT WWW.S OCRA.ORG 11 2 0 1 3 - 2 0 1 4 E ducation O pportunities Clinical Site Coordinator/ Manager Workshop Advanced Site Management: Finance and Productivity This workshop, for site coordinators, research associates, This workshop, for site managers and research associates, GCP for Site Coordinators, Research Associates, Study Nurses & Site Managers and study nurses with 0-5 years experience, reviews the responsibilities at the clinical research site. Enhanced Business Practices for Clinical Research Programs reviews billing, budgeting, profitability, and business best practices for clinical research programs. The purpose of this workshop is to SOCRA is pleased to assist Site Managers, Site Coordinators offer this workshop to and Research Associates in improving their skills and their understanding assist Site Coordinators, of the practical financial and business Research Associates, and Study Nurses in Helen Darwin, BSc, CCRP Darwin Site Management Services Program Committee and Faculty improving their skill and their understanding of the responsibilities of the tasks related to clinical research. Jim Simmer, MBA, RN Performance Research Ponte Vedra, FL Program Co-chairperson clinical research site. clinical trials according to Good Clinical issued by the International Conference on Harmonisation (ICH Guidelines), as well as practical procedures and site / sponsor / CRO relationships. The goal is accomplished through lecture and practical to benefit their clinical research programs. This program is offered three times per year. processes continues site related to the administration of Federal Regulations and the guidelines participants can immediately utilize practices and business all of the functions of the research Jacqueline Busheikin, RN, CCRP Jana Research Corp. Program Committee and Faculty tools and techniques that the The topic of financial This program is designed to address Practices as defined by the U.S. Code of This workshop focuses on providing to be a challenge for Andrew Snyder, MBA, FACMPE, PMP HealthEast HeartCare Clinic St. Paul, MN Program Co-chairperson clinical research sites. The goal is accomplished through lecture, case study, practical application and hands-on experimentation facilitated by experienced clinical research professionals. Information application facilitated by clinical research professionals and practical application recommendations are discussed 30 years. related to finance, productivity, budgeting, billing, with a combined industry experience of more than TransCelerate BioPharma: This ICH E6 GCP Investigator regarding all of the functions of the research site and executive reporting. Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. 12 SOC R A A NNUA L REP ORT 2014 2 0 1 3 - 2 0 1 4 E ducation O pportunities Clinical Science Course For Clinical Research Professionals The Clinical Science Course was first offered in 1995, as SOCRA’s flagship educational program. Since its inception, it has been revised and enhanced to meet the continually Clinical Research Professional Certification Preparation and GCP Review Course changing needs of our members. This program is divided The purpose of this workshop is to medical/scientific module, to maximize its value to course the SOCRA certification examination assist the participant in preparing for into 2 modules; a regulatory/procedural module and a and to review GCP regulations, policies, attendees. Attendees may elect to attend one (either) or and procedures appropriate to the both modules. clinical research environment. This course contains TWO modules. George D’Addamio, PhD PharmConsult, Inc. Program Committee and Faculty The attendee may elect to attend one (either) or both modules. Module 1 is the regulatory/procedural and ICH Good Clinical Practice (GCP) guidelines. Module I is the Regulatory / Procedural Module consisting Budgeting, Good Clinical Practice, ICH Guidelines, Informed Consent, Preparing for a GCP Audit, Regulatory Kathi Durdon, MA, CCRP Welch Allyn, Inc. Faculty Affairs and IRBs, IND/NDA, Research Ethics, and Source venues in 2013. Faculty review basic of clinical trials; regulatory guidelines pertaining to: Ethical Issues in Clinical Trials, Anatomy regarding IRB oversight and human and Physiology, Cell Biology, Genetics, Clinical Laboratory research protections; ethical issues in Analysis, Epidemiology, and Research Statistics. System IRB, University of Texas Health Science Center, to your institution, was offered at 12 and device development; the conduct Medical / Scientific Module consisting of sessions Children’s Research Hospital, Duke University Health The program, which can be brought concepts of GCP compliance; drug Documentation and Administration. Module 2 is the Faculty from esteemed institutions such as St. Jude preparing for the CCRP® review of FDA regulations scientific module. Clinical Pharmacology, Adverse Event Reporting, will aid participants in certification exam through module. Module 2 is the medical/ of sessions pertaining to: Drug Development Process, This one-day course Susan Devine, CCRP Hospital for Sick Children Faculty University of Maryland, and the Memorial Sloan Kettering clinical research; Good Clinical Practice and audits, misconduct and fraud. Attendees participate in a case study that stresses abstracting information and completing case report forms and other records. Cancer Center lead this program. TransCelerate BioPharma: This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Carolyn Rugloski, MS, CCRP Worldwide Clinical Trials (WCT) Faculty Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. VIS IT WWW.S OCRA.ORG 13 M E M B E R R E S O U R C E S and B E N E F I T S SOCRA offers a variety of resources to aid members in reaching their professional goals through education and networking. Quarterly Journal SOCRA’s quarterly publication, the SOCRA SOURCE, Journal for Clinical Research Excellence, is a journal offering scientific and technical information in the form of academic and instructional articles of interest to the clinical research professional. Articles consist of items submitted by interested members as well as specifically developed articles intended to meet a need expressed by the membership. A peer review process has been developed for selected articles. The journal contains a section advising the reader of planned educational programming, and scheduled certification examination sites, dates and times. The journal contains a section devoted to products and services available to the clinical research professional or their organization as well as career opportunities for clinical research professionals. Website SOCRA’s home page can be found at www.SOCRA. org. The site offers a presentation of all of our educational programming, locations, and links to hotels and meeting facilities, as well as local chapter information and meeting announcements. The site keeps our members up-to-date regarding the offerings of the society. A current listing of all of our certification examination sites may be found there. NEWSLETTERS and EMAIL UPDATES To aid members in staying current in changes in the industry, SOCRA periodically sends updates and alerts. Linkedin, Twitter and Facebook Stay connected with SOCRA by connecting with us on LinkedIn, Twitter (@SOCRAnow) and Facebook (socra.org). MEMBERSHIP DIRECTORY Our online Membership Directory may be found under the Membership heading of the website. The online directory was first launched in early 2007 and has provided quick access for member-tomember communication. 14 SOC R A A NNUA L REP ORT 2014 CAREER RESOURCES Our Careers and Services section offers our members a view of career opportunities in clinical research available through employers and recruiters associated with the pharmaceutical and health care industries. It includes opportunities in government, academia, and industry related to all therapeutic areas. Certification PROGRAM Reference Manual This compilation of selected sections of the U.S. Code of Federal Regulations (CFR) also includes the ICH (International Conference on Harmonisation) GCP Guidelines, the Declaration of Helsinki, the Belmont Report, the Nuremberg Code, and selected Health Canada documents. The reference manual is included in the certification application fee and is also available for purchase through the SOCRA office. CITI Program SOCRA offers no-cost Basic GCP and Research Protections online Education through the Collaborative Institutional Training Program (CITI). SoCRA has joined The Collaborative Institutional Training Program (CITI) to offer SOCRA members free entry-level basic courses in Human Subjects Research, Good Clinical Practice (GCP), Health Information Privacy and Security (HIPS), Animal Care and Use (ACU), and Responsible Conduct of Research (RCR). REcognition by TransCelerate BioPharma Clinical researchers who hold the SOCRA “CCRP,” Certified Clinical Research Professional designation, as well as those clinical researchers who complete specific SOCRA GCP courses (noted below), meet the minimum criteria for ICH GCP investigator site personnel training as identified by TransCelerate BioPharma member companies. Certification Preparation & GCP Review Course Clinical Site Coordinator/ Manager Workshop Conducting Clinical Trials in Canada Clinical Investigator GCP & Trials Management Conference 2 0 1 3 - 2 0 1 4 E ducation O pportunities Quality Improvement Through Standard Operating Procedures (SOPs) Harnessing Social Media to Advance Clinical Research SOCRA offers a program once per year on social media’s This workshop will consider fundamental concepts for the capabilities and benefits with regard to clinical research. development and implementation of effective SOPs. Featuring presenters on This two-day workshop reviews topics of social media fundamental concepts and current for recruitment, data issues in the development and implementation of effective SOPs for the investigational site. The workshop, Donna Headlee, RN, BSN, CCRP Program Chairperson Jody Green, PhD, CCRP Rocky Mountain Poison & Drug Center Program Chairperson offered once per year, is facilitated by clinical research professionals with experience and expertise in SOP development and implementation. collection, as well as legal and ethical issues encountered using social media in clinical research This program, intended for clinical research site Standard Operating Procedures (SOPs) administrators, managers, investigators, research nurses, are effective tools to assist in the other researchers and marketing personnel, considers the conduct of high quality clinical trials. impact of social media on healthcare and the regulatory environment, including the IRB’s perspective on the use of social media in clinical research as well as the clinical Participants will discuss basic principles and current research community’s ethical and legal responsibility to challenges regarding development, writing, and the clinical trial participant. The presenters share methods implementation of SOPs. The importance of strategies for using social media in various settings and review the for addressing the approval process, development newest concepts for the use of social media in clinical of a training program, and tracking of training and research. Topics also include social media as a method implementation results will also be discussed. for intervention and research collaboration, as well as This workshop consists of lectures, discussions, and applicable regulatory implications. interactive group exercises. Clinical Trial Management System (CTMS) Conference The purpose of this program is to assist clinical research site administrators, managers, system users, investigators, nurses, other researchers and financial personnel in evaluating Clinical Trial Management System (CTMS) capabilities and benefits. Andrew Snyder, MBA, FACMPE, PMP HealthEast HeartCare Clinic St. Paul, MN Program Chairperson This two-day conference reviews Participants will learn basic technical terms and concepts management system evaluation, to evaluate their organization in order to determine their related to CTMS. The program will teach individuals how strategies for clinical trial selection, implementation and management, as well as exhibits and demonstrations from CTMS vendors. CTMS requirements and to begin implementation. Revenue management, financial reporting and budgeting will also be discussed. VIS IT WWW.S OCRA.ORG 15 2 0 1 3 - 2 0 1 4 E ducation O pportunities FDA Clinical Trial Requirements, Regulations, Compliance and GCP conference SOCRA is pleased to offer this conference, jointly sponsored in 2014 Conducting Clinical Trials in Canada A Uniquely Canadian Perspective for All Clinical Research Professionals Answering requests from Canadian members, SOCRA offers a program on conducting clinical trials in Canada. with the U.S. FDA Los Angeles, Detroit This conference offers the San Francisco, Cincinnati and New perspective and will and Florida Districts, and in 2015 with a uniquely Canadian England Districts. assist all clinical This two-day conference, jointly sponsored with the U.S. FDA, shares information regarding clinical research regulations and GCP guidelines and discuss methods to aid the research professional in their practice. This conference is designed to enhance the participant’s Helen Darwin, BSc, CCRP Darwin Site Mgmt Services Program Co-Chairperson understanding of the mission, responsibilities, and FDA representatives. highlights the following areas: • FDA District Offices Role, Structure and Responsibilities • Modernizing FDA’s Clinical Trials / BIMO Programs • FDA’s Expectations for a Pharmaceutical Clinical Trial • Medical Device Aspects of Clinical Research • FDA Center for Biologics Regulation of Research • Adverse Event Reporting – Science, Regulation, Error and Safety • Ethical Issues in Subject Enrollment 16 • Keeping Informed and Working Together • FDA Conduct of Clinical Investigator Inspections • Investigator Initiated Research • Meetings with the FDA Why, When and How • Part 11 Compliance Electronic Signatures • IRB Regulations and FDA Inspections • Informed Consent Regulations • The Inspection is Over - What Happens Next? Possible FDA Compliance Actions of the responsibilities of conducting clinical Health Canada’s regulations for community to facilitate the understanding of regulations, product development understanding. This conference and their understanding This program features sessions on FDA representatives share information with the regulated opportunities to enhance the research professional’s in improving their skills research in CANADA. authority of the FDA and to encourage interaction with guidelines and practices, and to suggest methods and research professionals pharmaceutical and medical device Jacqueline Busheikin, RN, CCRP Jana Research Corp. Program Co-Chairperson clinical studies. Speakers also address current trends in clinical research and identify how these trends are influence clinical development now and into the future, as well as review ethical challenges for research in the Canadian regulatory environment; key elements in preparing for a Health Canada inspection and potential corrective and remedial actions for audit inspection findings . In addition, the program reviews critical analysis and risk management strategies to mitigate cultural challenges presented by multinational trials , in addition to discussing the objective, process, and final report of the ISCT (Initiative to Streamline Clinical Trials). TransCelerate BioPharma: This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. SOC R A A NNUA L REP ORT 2014 2 0 1 3 - 2 0 1 4 E ducation O pportunities Clinical Research Project/Program Management Conference Protecting Human Research Participants This conference considers project management and risk Legal, Ethical, and Practical Considerations management and global considerations for clinical Professionals reviews the activities and role of the FDA as management principles, budget development / financial This two-day conference for Clinical Research research programs. they affect record keeping, investigator responsibilities, IRB management issues, audits, the informed consent process, and This program will administrative activities falling under broaden the participants’ FDA regulations. The presenters discuss the responsibilities of knowledge of the these very important functions regulatory framework, Nancy Wintering, LCSW, CRC, CCRP Thomas Jefferson University Program Chairperson project management art Carolyn Rugloski, MSc, CCRP Worldwide Clinical Trials (WCT) Program Co-Chairperson and science, planning and accounting, and their attitude and aptitude for budgets involved in the health care product development Cheryl I. Jacobs, CCRP Translational Research Management Program Co-Chairperson process. The goal of this program is to introduce, affirm and enhance the participant’s understanding of the project management endeavor. Topics include: Principles of Initiation, Planning, Execution, Monitoring, Controlling, and Closing • Charts, Planning and Tracking Tools • Organizational Tools and Techniques • Organizational Dynamics in Project Management research subjects. Professional’s administer, track, evaluate and report activities and Management Institute) research and the protection of Clinical Research incorporate a broad range of skill sets in order to plan, • Introduction to PMI (Project contributor to successful clinical designed to aid the Clinical trial project and program management Infrastructure clinical researcher as a fundamental This conference is achieving successful clinical trials. • Developing an and the complementary role of the • Global Regulatory understanding of the legal, ethical, and practical considerations of human subjects research. The program focuses on the relationships among Considerations Affecting clinical trial staff, investigators, IRBs and the FDA. The the Project Plan conference highlights five areas that present challenges to sponsors and investigational sites: safety reporting, data • Creating a Study Budget monitoring, communication, education, and the informed and Managing Finances from Start Up to Close Out • Contract Development for consent process. The program features a case study on human safety protection considerations during clinical research study recruitment and enrollment endeavors. Good Outcomes • Planning for the Unexpected • Managing Multisite Projects & Projects Related to INDs and IDEs VIS IT WWW.S OCRA.ORG 17 2 0 1 3 - 2 0 1 4 E ducation O pportunities Device Research & Regulatory Conference The Premier Conference for Device Professionals (Plus optional Pre-Conference 1/2 day workshop DEVICE Basics) Pediatric Clinical Trials Conference SOCRA’s newest program, highlights specific to pediatric clinical trials. SOCRA’s newest educational program on pediatric clinical research was a great success. Offered This conference reviews fundamental concepts and current issues relating to DEVICE for the first time in research compliance, research February 2014, the development, and clinical investigation two day program for Device Research in the current regulatory environment. An optional half-day program on Device Basics for Kathi Durdon, MA, CCRP Welch Allyn, Inc. Program Chairperson participants new to device research precedes the main conference. Presenters discuss fundamental Lisa Benson, BS, CCRP, CRCP Connecticut Children’s Medical Center Program Chairperson concepts and current issues relating reviews regulatory, financial, and ethical components of conducting clinical trials in the pediatric population. to compliance, human subject protection, research development and clinical investigation in the current regulatory environment. Speakers from academia, The conference featured information and expertise. administration of clinical trials and discussion regarding the government (FDA) and industry share their knowledge according to FDA Regulations Device Half Day Workshop: DEVICE BASICS (Optional Pre-Conference) and International Conference on Susan Devine, CCRP Hospital for Sick Children Program Chairperson The Pre-Conference Workshop, designed for those new to research or for those who would like to have a refresher on the device clinical research regulations and guidances, offers a comprehensive overview for those interested in device clinical research and serves as a building block for the more advanced general session. Device Research: General Session This 2-day advanced conference includes experts involved in the research and development of safe and effective vulnerable populations. This conference highlights the following areas: • Unique Challenges of Conducting Clinical Trials in a Pediatric Setting • Regulatory Considerations in the Pediatric Population • Challenges Faced in Recruitment, Enrollment, and Retention medical devices. Topics include: 510(k) Program Update, Device Total Product Life Cycle (TPLC) Case Study from FDA experts, Conducting Device Trials in Ascending Markets, IVD trials, IRB Roles and Responsibilities, ISO 14155, as well as presentations from innovation, communication and human factors experts. 18 Harmonisation (ICH) regarding SOC R A A NNUA L REP ORT 2014 • Development of Pediatric Research Studies • Budgeting and Contracting • Project Planning and Management • Monitoring, Auditing and Compliance • Study Closeout CHAPTER DEVELOPMENT SOCRA’s chapter program was developed to help support In 2013, SOCRA chapters held 165 meetings throughout peer-to-peer education and foster a community for clinical meetings offered 212 CE to over 3,600 attendees. SOCRA’s continuing education at the local level. Local chapters support research continuing education and networking. SOCRA’s chapter model allows clinical research professionals to acquire no-cost continuing education credit. Interested members of SOCRA wishing to administer educational programming at the local level may organize a local chapter and plan clinical research education. Those interested may contact the SOCRA office for information and to discuss their educational programming. A SOCRA chapter’s membership consists of current members of SOCRA who are located within a non-exclusive geographic area defined by the local chapter. Therefore, the chapter’s “active” membership consists of those who are interested in developing and participating in the local chapter activities. the U.S.A., Canada, Brazil, Japan, and Saudi Arabia. These chapter program continues to grow, with over 50 chapters actively engaging their local clinical research community. SOCRA encourages the Chapter Chairperson Special Recognition chapters to provide a cost SOCRA recognizes that chapter development of local free forum under which members can learn, exchange information, grow professionally in clinical research, acquire CE for SOCRA CCRP® re-certification, and build strong foundations for successful clinical research outcomes. education programs, coupled with SOCRA programming, help our members to achieve personal and professional growth through continuing education. This award recognizes a SOCRA volunteer chapter chairperson for excellence in their commitment to this goal through the coordination of education to local clinical research professionals. This award recognizes the representative of the chapter granting the greatest amount of learning opportunities for the period between June 1 and May 31 annually. See page 9 for details regarding the 2013 recipient. CURRENT CHAPTERS INCLUDE: BRAZIL Sao Paulo CANADA British Columbia - Northern Vancouver Vancouver Island Nova Scotia - Halifax Ontario - Kingston Area London Ottawa Area Toronto Area Saudi Arabia Riyadh U.S.A. Alabama Arizona - P hoenix / Valley of the Sun Arkansas California - G reater Los Angeles Inland Empire Northern California Orange County San Diego Area Sylmar Colorado - Rocky Mountain Area Southern Colorado Connecticut District of Columbia - Nat’l Capital Area (DC/VA/MD) Florida - Central Florida North Florida South Florida Suncoast Georgia - Atlanta Idaho - Treasure Valley Illinois - Central Illinois Indiana - C rossroads (IN/OH/KY/IL) Southern Indiana Maryland - Baltimore Area Massachusetts - Boston Area Western MA Michigan - S aginaw Bay Area Southeast Minnesota - North Central Regional Southeast (MN/IA/WI) New Jersey - Northern (NJ/NY) New Mexico New York - Hudson Valley (NY/NJ) New York State Western NY North Carolina - NC East / RTP Area Ohio - Northeast Ohio Oklahoma - Central Oklahoma Oregon Pennsylvania - Harrisburg/ Hershey South Carolina - Palmetto Upstate South Dakota - Central Plains (SD/NE/IA/ND) Tennessee - Greater Nashville Greater Smoky Mtn Regional Mid-South Texas - Central Dallas / Ft. Worth Greater Houston / Galveston San Antonio West Texas Vermont Virginia - C entral Virginia Southeastern Virginia Washington State Wisconsin VIS IT WWW.S OCRA.ORG 19 SOCRA BOARD OF DIRECTORS 2013- 2014 SOCRA’s leadership is comprised of an all volunteer, 15 Member President Wendy H. Lloyd, BA, LPN, CCRP, CIP Regulatory Affairs & Compliance Specialist, Vanderbilt Univ. Medical Center, IRB Nashville, TN USA President Elect Jody L. Green, PhD, CCRP Director of Research Admin, Denver Health Rocky Mountain Poison & Drug Center Denver, CO USA Secretary Nancy A. Wintering, MSW, LCSW, CCRP Research Program Manager, Thomas Jefferson University Philadelphia, PA USA Treasurer Ann Marie Von Worley, RN, BSHS, CCRP Research Associate, Health Services Research Division, LCF Research Albuquerque, NM USA Board of Directors. Our volunteer leaders are clinical research professionals from all areas of clinical research, including academia, government and industry and with experience in a wide range of therapeutic areas. 20 SOC R A A NNUA L REP ORT 2014 Immediate Past President Daniel E. Redline, BA, CCRP Director, IRB Administration, University of California, Davis Sacramento, CA USA Directors Cheryl M. Chanaud, PhD, CCRP System Executive Director, Research, Memorial Hermann Healthcare System Houston, TX USA Maribelle Guloy, MSHS, CCRP Clinical Trials Director Clinical Trials and Research Associates, Inc. Montebello, CA USA John M. Furlong, RN, CCRP Director of Clinical Research Delaware Valley Clinical Research Cherry Hill, NJ USA Tammy S. Neseth, BS, CCRP Manager - IRB Regulatory Compliance Mayo Clinic Cancer Center CRO Rochester, MN USA Angela Rock, MBA, CCRP Manager, Clinical Research Associate Group BIOTRONIK Lake Oswego, OR USA Ruben Q. Rodarte, MBA, MS, CCRP Clinical Projects Director, Preventative Medicine, Pennington Biomedical Research Center, LSU System Baton Rouge, LA USA Susanna K. Sellmann, BSc, MRT, CCRP Quality Manager, Cancer Clinical Research Unit, Princess Margaret Hospital / University Health Network Toronto, ON, Canada Radhika Sivaramakrishna, PhD, PMP, CSSB, CCRP Senior Director, Project Management, Covance Princeton, NJ USA Mariah Tackett, MSPH, CCRP Associate Director, Clinical Operations St. Jude Medical Inc Implantable Electronic Systems Division Sylmar, CA USA Stephanie J. Zafonte, MSN, RN, RAC, CCRP Nurse Consultant/ Clinical Project Manager, NIH/NIAID Rockville, MD USA Jamie Harper, MHA, CCRP Director of Clinical Research Illinois CancerCare Peoria, IL USA Lenore JacksonPope, RN, BSN, MSM, CCRP Manager, Medical & Research Ed Massachusetts/ NH Chapter of The Alzheimer’s Association Watertown, MA USA Directors Elect Quincy J. Byrdsong, EdD, CIM, CIP, CCRP Associate VP for Health Sciences Strategic Initiatives & Engagement Virginia Commonwealth University Richmond, VA USA VIS IT WWW.S OCRA.ORG 21 MANAGEMENT The SOCRA management and Erich Lukas, MBA Executive Director Rita Lukas Administrative Director Kristen McNeill Associate Administrative Director Brent Williamson, MBA, CPIM Associate Executive Director Cindy Baker Membership Susan Benedetti, MSOL Program Management Laura Brewster Certification Laura Engebreth Data Management Susan Ciotti Events Management Anne Howell Continuing Education Linda Seidel Accounting Janis Skarbowski Recertification / Advertising / Exhibits administrative team has combined experience of more than 75 years in non-profit and association management. Our management team additionally has 25 years of experience working in healthcare, clinical research and the pharmaceutical industry. Our office provides accounting and financial management, membership records and dues management, meeting management and development, publications development and production, web site management, educational programming assistance, certification committee support and support for marketing and promotion activities. 22 SOC R A A NNUA L REP ORT 2014 EXECUTIVE DIRECTOR’S REPORT Thank you for your interest in clinical research and in SOCRA. Our organization and its stakeholders strive for excellence in all aspects Erich Lukas, MBA of clinical research. Executive Director raises the bar for quality research management and SOCRA has developed a culture that encourages the operations, and for subject care. highest levels of integrity and care from all who are involved in our leadership and from faculty and staff involved in our education and certification programs. We encourage our members to take advantage of “free content is valid, professionally developed, and delivered Chapter education programs, a totally volunteer effort, Our members and stakeholders can trust that program of cost” local education offered through our chapters. with utmost care. We administer our programs to were originally designed to allow our certified members to exceed expectations and to impart the highest levels of professionalism attainable. Our emphasis on Good Clinical (Research) Practices, quality research outcomes, and safety for the research subject, has surely contributed to a more professional and productive research environment. SOCRA’s Board of Directors and education committees have succeeded in broadening the course offerings to accrue required continuing education for re-certification at no cost and are also open to visitors. Our chapter chairs are open to your suggestions for speakers and topics. More than sixty chapters now offer valuable education opportunities throughout the year. As a provider of continuing nurse education (CNE) and include 16 programs offered at more than 35 venues continuing education for physicians (CME), SOCRA holds throughout the year. to the highest standards for identifying participant needs, determining educational objectives, selecting and We are also quite proud of the rate of growth of our presenting content, and ensuring that education delivery membership. Despite the difficult economy, our methods meet participant needs. membership has doubled during the last seven years to over 15,000 members. We sincerely appreciate the faith and confidence of The designation “Certified Clinical Research Professional (CCRP®),” is available to researchers working under to greater professionalism and expertise in clinical our members. They have selected SOCRA as their avenue research. As a result of our programming, the greater Good Clinical Practice (GCP) regulations, who meet reward granted to our Board of Directors, faculty, staff certain eligibility requirements that are stipulated in the and members, is their knowing that activities in research certification section of this report. The SOCRA Board of Directors, staff and faculty strive to are addressed by competent and disciplined clinical research professionals. offer our members the very best environment for learning, in order to promote the protection of research subjects Thank you for your trust, confidence, and support. and quality research outcomes. Our certification process VIS IT WWW.S OCRA.ORG 23 SOCRA Education Calendar 2014/2015 2014 OCTOBER 9 and 10 16 and 17 20 to 24 Baltimore, MD Clinical Research Project / Program Management New Orleans, LA Clinical Research Monitoring and GCP San Diego, CA Clinical Science Course NOVEMBER 5 and 6 13 and 14 17 L ake Buena Vista, FL FDA Clinical Trial Requirements Nashville, TN Clinical Site Coordinator / Manager - GCP Tampa, FL Certification Preparation and Review Course DECEMBER 4 4 and 5 11 and 12 Kansas City, KS Certification Preparation and Review Course Las Vegas, NV Clinical Investigator and GCP Workshop San Diego, CA Advanced Site Finance and Productivity 2015 JANUARY 29 and 30 FEBRUARY 5 5 and 6 12 and 13 26 and 27 27 MARCH 11 and 12 23 to 27 Las Vegas, NV Clinical Site Coordinator / Manager - GCP Los Angeles, CA Certification Preparation and Review Course San Diego, CA Clinical Research Monitoring and GCP San Diego, CA Pediatric Regulatory Conference New Orleans, LA SOP Development and Implementation New Orleans, LA Certification Preparation and Review Course S an Francisco, CA FDA Clinical Trial Requirements Lake Buena Vista, FL Clinical Science Course APRIL 13 and 14 T oronto, ON Canada Clinical Site Coordinator / Manager - GCP 16 and 17 San Francisco, CA Protecting Human Research Participants Legal, Ethical & Practical Considerations 23 and 24 Denver, CO Advanced Site Finance and Productivity 30 and May 1 Toronto, ON Conducting Clinical Trials in Canada MAY 6 to 8 13 and 14 24 S an Diego, CA Clinical Device Research (and Device Basics Preconference) Cincinnati, OH FDA Clinical Trial Requirements SOC R A A NN JUNE 18 and 19 18 and 19 JULY 9 and 10 20 to 24 30 and 31 SEPTEMBER 16 17 to 20 OCTOBER 8 and 9 19 to 23 22 and 23 NOVEMBER 4 and 5 12 and 13 DECEMBER 3 and 4 10 and 11 Society of Clinical Research Associates 530 West Butler Avenue USuite A L109 R E P O R T 2 0 Chalfont, PA 18914 USA 14 Nashville, TN Clinical Research Monitoring and GCP Nashville, TN Advanced Site Finance and Productivity S an Francisco, CA Harnessing Social Media to Advance Clinical Research Chicago, IL Clinical Science Course Chicago, IL Clinical Site Coordinator / Manager - GCP Denver, CO Certification Preparation and Review Course Denver, CO Annual Conference (and preconference workshops) Philadelphia, PA Clinical Research Monitoring and GCP Scottsdale, AZ Clinical Science Course Scottsdale, AZ Clinical Research Project / Program Management Boston, MA FDA Clinical Trial Requirements Lake Buena Vista, FL Clinical Site Coordinator / Manager – GCP Tampa, FL Clinical Investigator and GCP Workshop Las Vegas, NV Advanced Site Finance and Productivity Phone: (800) 762-7292 or (215) 822-8644 Fax: (215) 822-8633 E-mail: office@socra.org www.SOCRA.org