Fundamentals of Clinical Research (US)

Registration is open now for the following courses:

• San Francisco, California, Sept. 30 - Oct. 1 — Details, Register
• Houston, Texas, Oct. 7-8 — Details, Register
• Alexandria, Virginia, Nov.4-5 — Details, Register

Course Description
This newly revised and expanded two-day course provides the core knowledge and skills that clinical research professionals who have up to 18 months practical experience in clinical trials need in order to better execute their functions. Participants may come from investigator sites, pharmaceutical, device or biologics companies. On Day 2, CRCs and CRAs break out into separate sessions where they can concentrate on the strategies and tools needed to best perform their responsibilities. The training program is presented by industry experts using case studies and other interactive activities. The focus is on understanding the principles of performing intelligent, responsible and successful clinical research.
View a Course Agenda

Target Audience
Fundamentals of Clinical Research is designed for those who aspire to the following roles: clinical research professionals managing studies at clinical research sites or monitoring studies, product managers, clinical investigators, institutional review board members, clinical pharmacologists, and research pharmacists.

• Discuss the main historical events which led to the increasing regulation of the development of medicinal products, devices and biologics
• Explain the differences in the development processes for medicinal products, devices and biologics
• Identify the roles and responsibilities of clinical research professionals in the overall process of conducting a clinical trial and how each professional contributes to that process
• Apply the principles of Good Clinical Practice (GCP) in their daily functions
• Identify the main regulations which govern the practice of clinical research
• Observe the additional rules applicable to research funded by bodies like the NCI and NIH and research funded by the Federal government
• Identify ethical issues involved with conducting clinical research
• Identify the protections given to human subjects
• Describe the process of obtaining informed consent from human subjects
• Describe the respective roles and responsibilities of clinical research professionals notably Clinical Research Coordinators (CRCs), and Clinical Research Associates (CRAs)
• Identify and evaluate unanticipated problems
• Define the criteria for reporting unanticipated problems and adverse events

Trainers
ACRP only uses experienced, proven instructors. In certain cases, instructors may be substituted depending on availability. View details for each event for full trainer information.

Accreditation Info

Continuing Nursing Education The Association of Clinical Research Professionals (ACRP) is accredited as a provider of continuing nursing education by the California Board of Registered Nursing (Provider Number 11147). Program No. 11147-09-500 - 12 contact hours/credits Continuing Medical Education Accreditation Statement The Association of Clinical Research Professionals (ACRP) is accredited by the Accreditation Council for Continuing Medical Education to provide Continuing Medical Education for physicians. Credit Statement The Association of Clinical Research Professionals designates this educational activity for a maximum of 12 AMA PRA Category 1 credits™. Each physician should only claim credit commensurate with the extent of their participation in the activity (Program Number 0007229-09-CME-500). Association of Clinical Research Professionals The Association of Clinical Research Professionals (ACRP) provides 12.0 continuing education credits for the completion of this educational activity.  These credits can be used to meet the certification maintenance requirements.  (ACRP-2009-SEM-500) Continuing education statements of credit will be distributed within four weeks of the program to those individuals completing and submitting evaluation forms at the end of the seminar. No partial continuing education credit will be awarded. You must stay the entire session to receive credit. A completed evaluation form must be submitted at the end of the seminar in order to receive contact hours. Certificates of attendance are available for attendees who do not attend the full seminar. Attendance certificates may be used for ACRP recertification but not for licensure renewal.