Course Description

This two-day course will cover topics designed to explain exactly what a clinical trial is and how clinical research is conducted. Since many clinical trials are often conducted in the European Union (EU), we will also include some key EU requirements. We will start by looking at the history of clinical trials to give you a better understanding of how and why current regulations were created to protect and inform clinical trial participants as well as ensure the public that the information obtained from those trials is accurate and reliable. Then we will look at the process of drug and device development from discovery to approval. We will introduce you to the protocol which is the blueprint for any clinical trial and explain what an informed consent is and why it is so important. In addition to these key trial documents, we will also review other important documents that are used in clinical trials. Finally, we will provide you with resources that will enable you to stay informed about topics and regulations regarding clinical trials in the U.S. and in the European Union.

Learning Objectives

• Identify the members of the clinical research team and describe their primary roles and responsibilities
• Describe the difference between drug development and medical device development
• Discuss the historical events and importance of Good Clinical Practice (GCP) in clinical research conducted throughout the world
• Identify key FDA and EU regulations that pertain to clinical research
• Describe what a clinical protocol, informed consent, investigator’s brochure, and essential documents are and their importance in clinical trials
• Identify how safety information is collected and reviewed during clinical trials
• Define and identify adverse events

Who Should Attend

• Clinical Research Associates and Clinical Research Coordinators with less than six months experience
• Nurses
• Individuals interested in the fundamentals of clinical research and clinical trials
• Aspiring Clinical Research Associates and Clinical Research Coordinators
• College Students and New Graduates considering a career in clinical research
• Individuals considering participating in a clinical trial or know of someone who is considering participating in a clinical trial

Instructor

The course will be led by one of the following instructors:

Nikki Christison, B.S., C.C.R.A., T.I.A.C.R.

Sonja Cooper, Ph.D., M.B.A.

Janet Ellen Holwell, C.C.R.C., C.C.R.A., T.I.A.C.R., F.A.C.R.P.

Lily Romero, P.A., C.C.R.C.

Elizabeth Weeks-Rowe, LVN, C.C.R.A.

Click here for complete trainer biographies

Course Outline

Day One

• The Evolution of Research Ethics
• Good Clinical Practice  
• Investigational Product Development  
• Clinical Research Team  

Day Two

• Elements of a Good Clinical Study
• Informed Consent and Confidentiality  
• Clinical Trials and Safety Information  
• Audits and Inspections  

Interactive Activities

• Discussion: Ethics in Clinical Research
• Protocol and Informed Consent Review
• Recruitment Advertisement Review
• Identifying and Delineating Clinical Research Team Roles and Responsibilities
• Adverse Event Identification Exercise

Registration Fees

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 15 hours (1.5 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-004-L99-P. Released: 3/24.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.