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 3 ways devices are characterized
- Prepare and conduct a pre-investigation visit, an investigator’s meeting, an initiation visit, a periodic 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 audit
- CRAs with 1-2 years of experience, 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:
Gary B. Freeman, M.S., C.C.R.A.
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Day 1: 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; pre-investigation and confidentiality agreement; investigator/site selection; contracts/agreements; investigator’s meeting; initiation visit; recruitment and advertising
Day 2: 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;
Day 3: 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 Audits: Purpose, types and mechanics of FDA audits; common audit findings; FDA actions following an audit; the ‘dos’ and ‘don’ts’ in the event of an FDA audit
- 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
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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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 mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-10-007-L01-P. Released: 6/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.