This online 10-Week program 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 devices 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.
Prior to the start of the course, participants will receive their login credentials and links to access and download the many class resources and class meeting links. 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 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 close-out 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 FDA inspection process and what can be learned from issues warning letters
- Module 1: Introduction to the FDA and the Medical Device Approval Process: Introduction to the FDA; ICH overview; definitions; medical device regulatory processes
- Module 2: US Good Clinical Practices: Concept of Good Clinical Practices; US GCP – sponsor, investigator and IRB obligations;
overview of monitor’s responsibilities
- Module 3: IRB Approval & Informed Consent Process: IRB application for approval; approval process – initial and ongoing; informed consent process and documentation; HIPAA authorization
- Module 4: 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
- Module 5: Study Documentation: Sponsor files; investigator files; source documentation; case report forms; communication
- Module 6: Monitoring: Roles and responsibilities of the monitor during periodic visits; source document verification; case report form review in EDC; data retrieval and correction; document retrieval; protocol, investigational plan and GCP deviations; monitoring documentation
- Module 7: Device Accountability: Sponsor responsibilities as they relate to device accountability; investigator responsibilities as they relate to device accountability
- Module 8: Close-out Visits: Reasons for a closeout visit; roles and responsibilities of the monitor during a closeout visit; investigator responsibilities after closeout
- Module 9: 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
- Module 10: FDA Inspections: Purpose, types and mechanics of FDA inspections; common audit findings; FDA actions following an
inspection; review of warning letters
- 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 GCP
NOTE: This course is for individual registrants only and does not allow for group training.
What participants say about Barnett's 10-Week courses
...
“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!”
The course will be led by one of the following instructors:
Heather Marshall, M.S.N., B.S.N., R.N.
Shana Zink, B.S., C.C.R.A.
Click here for complete trainer
biographies
10 weeks for 3 hours each week.
Registration Fees
$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#: 0778-0000-25-025-L99-P. Released: 2/25.
Hold
this course at your company! For more information, contact Naila Ganatra at +1
215.413.2471.