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.
- 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
- 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
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
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
- 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 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
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.