10-Week Fundamentals of Clinical Research Series provides a comprehensive
introduction to clinical research for those who are new to or interested in
working on pharmaceutical and medical device clinical trials. Participants will
learn about the basics of clinical research, including industry practices and
rationale, and how key concepts apply directly toward clinical research
efforts, which are often mandated by regulations and guidelines. The series
covers core sponsor and investigator site activities to help learners understand
the key considerations in the real-life work of clinical researchers.
The resources required to
take this on-line course are already at your fingertips - an Internet
connection and a phone. After registering, you will receive an email
confirmation that provides you with the Web Seminar link and audio connection
Prior to the start of the
course, participants will receive comprehensive course materials. Come to class
prepared to interact – you will be able to ask questions, provide feedback and
participate in discussions and group work. Upon course completion, participants
will be provided training certificates. In order to receive accreditation CEUs,
participants are required to pass both a mid-term and final exam. Upon
completion of the exams, CEU certificates will be provided.
- Define clinical research and discuss how
preclinical development leads to clinical development
- Explain the roles and
responsibilities of all members of the clinical team: Sponsor, vendor,
CRO, investigator, Institutional Review Board, subject and regulatory
- Describe the investigational product
development process including study design and the logic involved
- Define the regulatory requirements,
including principles of Good Clinical Practice from the International
Council for Harmonization, FDA regulations
- (Code of Federal Regulations),
ethical considerations for a study and the need for Standard Operating
- Define the steps involved in
proceeding with the study: Sponsor development of protocol, case report
form, informed consent document, budget, database and identifying an
- Describe the conduct of the study
including monitor visits to the site and site performance management and
- Describe the management of adverse
events and completion of study reporting and retention of documents
- Identify career opportunities and
reference materials available
- Module 1: Clinical Research: What’s it all about?
- Module 2: Players: Who participates
and what is their role?
- Module 3: Game Plan: How are new
drugs/medical devices developed?
- Module 4: Rule Book: There are
always rules – which ones apply to research?
- Module 5: Designing: Are all
studies the same?
- Module 6: Preparation: Where do you
start with involving clinical sites?
- Module 7: Daily Life: What’s
involved in day-to-day clinical research life?
- Module 8: After the Game: What’s
involved in follow-up and reporting?
- Module 9: Pay-back: What’s involved
in bringing a product to market?
- Module 10: After life: Does the FDA
get involved and which career pathways might be available?
- Those who are new to clinical research
- Aspiring Clinical Research
Coordinators and Clinical Research Associates
- Nurses interested in clinical
- Aspiring and Entry Level Project
Managers (looking to gain experience in clinical research)
- College Students and New Graduates
in a Scientific Field
NOTE: This course is for
individual registrants only and does not allow for group training.
What participants say about Barnett's 10-Week courses
“Great course! Instruction is expertly led and engaging. I
will recommend Barnett to any colleague and will seek out topics for my own
future training and professional development needs.”
"The course has been so incredibly helpful thus far...I
look forward to Thursday evenings!"
“This class exceeded my expectations of an online learning
experience. The instructor was knowledgeable, came equipped with great examples
to keep the class interesting and is a strong presenter. Thank you!”
Angie Maurer, R.N., B.S.N., M.B.A.
Click here for complete trainer
10 weeks for 2 hours each week.
$1,795 by Early Bird Deadline
$1,995 after Early Bird Deadline
This course is for individual
registrants only and does not allow for group training.
All participants are eligible for
“Certificates of Attendance,” and accreditation, provided that accreditation
requirements are met.
Barnett International is
accredited by the Accreditation Council for Pharmacy Education as a provider of
continuing pharmacy education. Participants will receive 20 hours
(2.0 CEUs) of continuing education credit for full participation, including the
completion of a mid-term exam, final exam, and program evaluation. Barnett
International will issue a receipt of completion for earned CEUs within three
weeks of program completion. ACPE#: 0778-0000-18-027-L01-P. Released: 2/18.
this course at your company! For more information, contact Naila Ganatra at +1