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 blue print 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:

Marla Hoelle, R.N., B.S.N., C.C.R.A.-PM, P.M.P.

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

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

Day Two: 8:30 a.m. – 5:00 p.m.

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

Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.

Special rates are available for multiple attendees from the same organization. Contact Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

Click here for our seminar cancellation policy

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#: 0778-0000-18-005-L01-P. Released: 5/18.

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