Cert Prep Review

CRP Certification, Preparation, and Review Course

Dates, Location, Contact Information, Fees, and Credit Hours
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Goal
Objective
Learning Objectives
Course Faculty
Course Agenda
Online Registration Form (Credit Card)
Course Registration Form (PDF)
Registration Late Transfer Form (PDF)
How to Host This Course

Dates, Location, Contact Information, Fees, and Credit Hours

Sept 18, 2009 Jesse H. Jones Rotary House International 1600 Holcombe Boulevard Houston, TX 77030 USA 09510

Sept 23, 2009 Gaylord Opryland Resort & Convention Center 2800 Opryland Drive Nashville, TN 37214 USAHotel Phone: 615-883-2211 Reservations: 888 777 6779

October 5, 2009 Farmington, CT With University of Connecticut Health Center - Human Subject Protection Office University of Connecticut Health Center- HR Training Center 16 Munson Road Farmington, CT 06030 USA Facility Phone: 860-679-8802

November 5, 2009 Durham, NC With Family Health International At the Hamner Conference Center 15 TW Alexander Drive, Research Triangle Park, NC USA

Fees

SoCRA member: $295
Non-member: $370

Non-member fee includes membership for one year.

Credit Hours

Continuing Education Credit Hours
SoCRA designates this educational activity for a maximum of 6.25 Continuing Education Credit Hours for SoCRA CE, Nurse CNE, and Physician Category 1 CME.

Accreditation Statements:

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.
CNE for Nurses: This continuing nursing education activity was approved by the PA State Nurses Association, an accredited approver by the American Nurses Credentialing Center’s Commission on Accreditation. ANCC/PSNA Provider Reference Number: 072-1-A-07

SoCRA Course Series: 500

The CCRP Certification Examination is offered throughout the year. Enrollment in the SoCRA Certification Exam requires a separate application and fee. Please visit HERE for more information.
Your CCRP Certification Examination Registration materials must be received by the SoCRA administrative office six weeks prior to the exam date.

Goal

The Society of Clinical Research Associates (SoCRA) recognizes Certified Clinical Research Professionals (CCRPs) as clinical researchers who meet an internationally accepted standard of knowledge, education and experience. The purpose of this workshop is to assist the participant in preparing for the SoCRA examination for the Certified Clinical Research Professional examination and to review regulations, policies, and procedures appropriate to the clinical research environment.

Objective

The goal will be accomplished through lecture, discussion and practical application facilitated by certified clinical research professionals with combined clinical research experience of more than 20 years. Information will be presented and discussed regarding the conduct of clinical trials; regulatory guidelines regarding IRB oversight and human research protections; ethical issues in clinical research; and workshops will stress the ability to follow directions and practices related to abstracting information and completing case report forms and other records.

Learning Objectives

Upon completion of the workshop, the attendee should be able to:

Discuss the basic requirements necessary to meet the demands of a CRP in clinical practice
Discuss the basic components of compliance - Law, regulation, guidance, policy and procedure
Explain the drug/biologic development process
Describe the device development process
Outline concepts for Good Clinical Practice (GCP)
Explain the elements of informed consent
Describe the membership and reporting requirements of IRBs
Explain rules relating to financial disclosure
Discuss the basics of study design
Explain the rules and reporting requirements for adverse events and serious adverse events
Explain study closure procedures and record retention guidelines
Outline the reasons for monitoring, audits and site visits
Explain the Food and Drug Administration rules, regulations, and guidelines on research
Discuss the importance of investigational drug accountability
Demonstrate and describe how to read clinical reports and records
Discuss Quality Assurance including, Monitoring and Auditing
Explain issues that would constitute clinical fraud

Course Faculty

Course faculty would be one of the following instructors.

George D’Addamio is President of PharmConsult, Inc., a consulting company in Atlanta, GA. During 8 years at SmithKline & French Laboratories (now Glaxo SmithKline), Dr. D’Addamio was responsible for preparing protocols, case report forms, integrated study reports, and regulatory submissions in Clinical R&D and Medical Affairs. As Scientific Manager, Clinical R&D, he was responsible for coordinating clinical research programs in Canada, Latin America, and the Pacific conducted under the US IND. In Medical Affairs, he managed operational groups responsible for medical writing, clinical monitoring, and safety reviews and quality control checks of CRFs. After leaving SK&F, Dr. D’Addamio worked for a CRO for 1.5 years before forming PharmConsult in 1987. Previous consulting experience includes project management, data management, statistical services, and medical writing. Currently, PharmConsult specializes in preparation of clinical development documents in various therapeutic areas for domestic and foreign pharmaceutical companies.

Susan Devine, CCRP is Manager of the Clinical Trial Support Unit of Hematology/Oncology at the Hospital for Sick Children in Toronto and previously Clinical Trials Manager at Montreal Children’s Hospital, McGill University. Involved in pediatric hematology, oncology and bone marrow transplant clinical trials for more than twenty three years, she has experience in all facets of clinical trial facilitation including study initiation, case report form development, regulatory compliance and monitoring. Ms. Devine currently serves as Chair of the Children's Oncology Group CRA Discipline and is a member of the COG Executive Committee. She is a member of the American Society of Clinical Oncology and is also a SoCRA Board member.

Joanne Goldberg, M.Sc, pht, CCRP is an independent Clinical Research Quality Compliance and Training Consultant in, Montréal Quebec, CANADA. She holds a Master of Science degree in Biomedical Sciences from the University of Montréal as well as a Bachelor of Sciences degree in Physiotherapy from the same institution. She has been involved in clinical research for the last 16 years and has held many positions including Director of Clinical Research Quality Compliance & Training, Director of Clinical Site Network Management, Director of Quality Management Systems, Senior Project Manager, Senior Study Coordinator, and Principal Investigator. Her expertise is primarily in clinical research quality management, training in Good Clinical Practices, study methodology, writing and implementing standard operating procedures as well as in team management. She is certified by the Society of Clinical Research Associates as a Clinical Research Professional and is responsible for the French language translation of the SoCRA certification examination and Preparatory Course. She is also a member of SoCRA’s Board of Directors.

Carolyn E. Rugloski, MSc, CCRP, is the Director, Medical Organization Training and Standards at MedImmune located in Gaithersburg, Maryland. Ms. Rugloski has over twenty-five years of clinical trial experience serving in a management role in the clinical research areas of data management, monitoring, training, project management, quality assurance, and business development. She has dedicated herself over the years to the training of clinical trial professionals through SoCRA and other educational organizations. Recognized internationally as a Good Clinical Practice (GCP) Trainer subject matter expert, Ms. Rugloski has lectured in North America, Europe, and the Pacific Rim. Ms. Rugloski is a past member of the SoCRA Board of Directors and continues to assist in the development and delivery of SoCRA events.

Kathi Durdon, MA, CCRP, is a Clinical Operations Associate with device manufacturer, Welch Allyn, Inc., based in Skaneateles Falls, NY. Previously, Ms. Durdon directed the Clinical Trials Office at State University of New York (SUNY) Upstate Medical University in Syracuse, NY. Kathi has been responsible for development of medical conferences and comprehensive education programs as well as resource development and budget negotiation throughout her 15-year tenure at Upstate. As CRA at Welch Allyn, she provides GCP and GMP training, SOP development and all aspects of project management for device clinical trials. Kathi is certified by the Society of Clinical Research Associates (SoCRA) as a Clinical Research Professional, speaks frequently at SoCRA courses, is a member of SoCRA’s Board of Directors and is the New York State Chapter Chair. Ms. Durdon holds Bachelor of Arts degrees in both English and Anthropology from the State University of New York (SUNY) Potsdam College as well as a Master of Arts degree in Business Policy from the State University of New York (SUNY) Empire State College.

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