BARNETT LIVE SEMINAR
Thursday, September 18
Course Description
This course presents the elements of the informed consent document and the components of the process, specifically as they relate to biobanking studies.
Participants will receive 7 hours (0.7 CEUs) from Accreditation Council for Pharmacy Education for full participation.
Agenda
8:30-9:15 am
Module 1
Introduction to Ethics in Informed Consent: Roles and Responsibilities
- Sponsor/Monitor
- Institutional Review Board
- Clinical Investigator
9:15-10:00 am
Module 2
Informed Consent: Document Elements
Break 10:00-10:15 am
10:15 am-12:00 pm
Module 3
Informed Consent: Document Elements
- Regulations and Guidance
- OHRP
- FDA
- ICH
- NCI
Lunch 12:00-1:00 pm
1:00-1:45 pm
Module 4
Confidentiality
1:45-2:30 pm and 2:45-3:15 pm
Module 5
Informed Consent: Process
Break 2:30-2:45 pm
3:15-4:30 pm
Module 6
Regulatory Findings
- Regulations and Guidance
- OHRP
- OCR
- FDA
- NIH
4:30-5:00 pm
Questions and Adjourn
Instructor
Elizabeth Ronk Nelson, M.P.H.
Elizabeth has over 20 years of experience in medical and clinical research. During her career, she has managed clinical trial site operations as a clinical research program coordinator and researcher and has served as an IRB Quality Assurance Specialist and a Senior (GCP) Auditor, Trainer, and Compliance Director. Her professional areas of specialization include fraud detection and prevention; mock FDA audits; customized, audit finding-specific, risk-based training; independent GCP quality systems and compliance audits; SOP and training program development and gap analysis; corrective and preventative action (CAPA) and quality systems improvement plans for GCP; customized skill-based training for clinical research professionals; clinical investigator site and IRB development and quality improvement (QI) plans; vendor audits/assessments; and site selection/qualification assessments. Ms. Nelson has extensive experience in investigating and pursuing suspect clinical data cases and has worked professionally with industry and government representatives to pursue legal actions for severe noncompliance cases.
*Separate Registration Required