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.

Learning Objectives

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

Who Should Attend

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

Instructor

The course will be led by one of the following instructors:

Shana Zink, B.S.

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Course Outline

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

Interactive Activities

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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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.

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Accreditation Information

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 competed: 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.