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:
Douglas E. Albrecht, B.S.N., C.C.R.A.
Gary B. Freeman, M.S., C.C.R.A.
Hillary Kimes, R.N., M.S.N., C.C.R.A., C.C.R.C.
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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;
monitoring documentation
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
October 13-15, 2010
Chicago, IL
Course #SDOC1010
Embassy Suites Chicago Downtown/Lakefront
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Register Early and Save!
$1,695 by September 10
$1,895 after September 10
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 Elizabeth Andrews 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 15 hours (1.5 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.
The New Jersey State Nurses Association (NJSNA) is accredited by the American Nurses Credentialing Center (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 21 Contact Hours. Approval Number: 6661-1/08-10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.