This
course provides an in-depth overview of the medical device development process
and the role of the Clinical Research Associate (CRA) in managing and
monitoring medical device studies. This course is ideal for CRAs new to the
device industry, as well as experienced CRAs who are transitioning from monitoring drug studies to monitoring device
studies.
- Discuss the FDA regulations pertaining to
clinical research and describe the ICH structure and function
- Define the common terms used in the
field of device clinical research and identify the three ways devices are
characterized
- Prepare and conduct a
pre-investigation visit, an investigator’s meeting, an initiation visit, a
periodic visit, and a closeout visit
- List the types of regulatory and
study documents required for the sponsor and for the investigator
- List both the sponsor’s and
investigator’s obligations as they relate to device accountability
- Describe the differences between
adverse events, adverse device effects, and unanticipated adverse device
effects
- Discuss the “dos and don’ts” in the
event of an FDA inspection
- CRAs with one to two years of experience, and
Engineers and other Device Industry Professionals responsible for the
placement and monitoring of clinical trials, who want a practical,
hands-on introduction to monitoring medical device studies according to
Good Clinical Practice
The course will be led by one of the following instructors:
Shana Zink, B.S.
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biographies
Day One: 8:30 a.m. – 5:00 p.m.
- Introduction to the FDA and the Medical Device
Approval Process: Introduction to the FDA; ICH overview;
definitions; medical device regulatory processes
- US Good Clinical Practices: Concept of Good Clinical Practices; US GCP – sponsor, investigator
and IRB obligations; overview of monitor’s responsibilities
- IRB Approval & Informed Consent Process: IRB application for approval; approval process – initial
and ongoing; informed consent process and documentation; HIPAA authorization
- Pre-Study Processes: Determining the sponsor’s investigator/site needs;
preinvestigation and confidentiality agreement; investigator/site selection;
contracts/agreements; investigator’s meeting; initiation visit;
recruitment and advertising
Day
Two: 8:30 a.m. – 5:00 p.m.
- Study Documentation: Sponsor files; investigator files; source documentation;
case report forms; communication
- Monitoring: Roles and responsibilities of the monitor during
periodic visits; source document verification; case report form review and
correction onsite; data retrieval and correction; document retrieval;
protocol, investigational plan and GCP deviations; monitoring
documentation
Day
Three: 8:30 a.m. – 5:00 p.m.
- Device Accountability: Sponsor responsibilities as they relate to device accountability;
investigator responsibilities as they relate to device accountability
- Close-out Visits: Reasons for a closeout visit; roles and responsibilities
of the monitor during a closeout visit; investigator responsibilities
after closeout
- Managing and Reporting Adverse Events: Adverse event terminology; variations in adverse event
reporting and documentation; sponsor obligations relating to adverse event
reporting; investigator obligations relating to adverse event reporting
- FDA Inspections: Purpose, types and mechanics of FDA inspections; common
audit findings; FDA actions following an inspection; the ‘dos’ and
‘don’ts’ in the event of an FDA inspection
- Monitoring Skills – Hands-On Simulation
- Monitor Group Discussions – Includes
Case Studies for Monitor Visits, Device Accountability, Informed Consent
Review, and Monitoring Priorities
- The Device Approval Process –
Classifying Devices and Determining Pathways to Marketing
- Selecting Study Sites
- Coaching Tips for an FDA Inspection
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information
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.
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cancellation policy
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 22.5 hours (2.25 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#: 0778-0000-20-005-L01-P.
Released: 3/20.
The New Jersey State Nurses Association is accredited by the ANCC Commission on Accreditation of the American Nurses Association as an approver of continuing education for nursing. As an accredited body, NJSNA has approved this program for: Contact hours completed: 20.5 Approval Number: 7894-1/19-21
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.