Clinical
trials play a pivotal role in evidence-based medicine. This 30-Hour Design and
Conduct of Clinical Trials Program will provide important epidemiological and
statistical principles necessary for designing clinical research studies.
Topics include bias, confounding, developing the research question, defining an
appropriate study population, choosing outcome measures, clinical research
ethics and regulation, sample size determination, and statistical analysis
issues. All aspects of the development and writing informed consent form and
study protocol will be addressed, including criteria for the selection of
participants, assignment of study treatments, and endpoints, randomization
procedures, adverse event reporting, and protocol compliance monitoring. The
ethical issues that arise at each phase of new biomedical product development
will be explored. Practical exercises will include critical analysis of the
informed consent form and development of a preliminary Investigational New Drug
(IND) submission strategy to the FDA.
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
information.
Prior to the start of the
course, participants will receive Module 1 materials. Course materials for
subsequent modules will be sent weekly prior to class. 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.
- Discuss the FDA’s role in biomedical product
development process
- Provide overview of regulations and
guidance documents for drugs, devices and biologics submissions
- Discuss content and requirements for
IND and Investigational New Device (IDE) applications
- Review the fundamentals of clinical
trial structure and design, including Phase I, II, and III clinical
studies
- Identify scientific and practical
issues associated with the planning of clinical research study
- Describe the overall structure of a
protocol and regulatory requirements
- Manage the timeline for protocols
and their amendments, including internal and external review, key opinion
leader input, collation, revisions, Quality Control (QC) process,
sign-off/approvals, and meetings
- Discuss requirements for protection
of human research subjects and their applications in responsible conduct
of clinical research studies
- Discuss the requirements for
pre-market New Drug Application (NDA) and Biologic License Application
(BLA) and Pre-Market Application (PMA) content and regulatory process
- Explain the post-approval
responsibilities of sponsors, including Phase 4 clinical studies
- Module 1: Overview of Drug/Device Development
Process for FDA Regulated Studies
- Module 2: Study Designs: Types of
Observational Studies and the Basics of Prospective Design
- Module 3: IRB Regulations and
Process, Informed Consent and the Regulations
- Module 4: INDs, the IND Process
- Module 5: Safety Monitoring for
Clinical Trials
- Module 6: Statistical
Considerations in Design and Analysis of Clinical Research Studies, Random
and Systemic Error in Clinical Study Designs: Controlling for Bias and
Confounders
- Module 7: Fundamentals of Trials
with Medical Devices
- Module 8: Pre-Marketing
Applications for Investigational Drugs and Biologics. Requirements for the
NDA, BLA PMA
- Module 9: Review of Protocol Types,
Special Designation Status (Multi-Center, Orphan Designation, Fast-Track),
Post-Marketing Studies
- Module 10: Bioequivalence Studies
for Development of Generic Drugs
- New Clinical, Regulatory, and Department Staff
who will design clinical trial programs
- Clinical Research Associates, Data
Managers or others interested in transitioning into clinical trial
management
- Project Team Leaders with limited
direct clinical trial experience who will be managing drug development
programs and supervising project managers
- Grant Administrators
- Medical Directors
- Medical Writers
- Clinical Research Associates
- Regulatory Affairs Professionals
- Research and Development Personnel
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!”
Marina
Malikova, PhD, MSci, MA, CCRA, RAC
Click here for complete trainer
biographies
10 weeks for 3 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 30 hours (3.0 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#: 0778-0000-20-102-L04-P. Released: 9/20.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.