Program Title: Informed Consent Procedure: What Can We Learn from Inspection Findings?
Location: Cincinnati Eye Institute, 1945 CEI Drive, Blue Ash, OH
Speaker: Janet Ellen Holwell
Registration Fees:
- Chapter Member - $0 Registration / $$0 Registration with Contact Hours
- ACRP Member - $10 Registration / $25 Registration with Contact Hours
- Non-Member - $30 Registration / $60 Registration with Contact Hours
Program Description: Informed Consent irregularities remain one of the leading findings in FDA and EMA inspections. This webinar examines actual cases of FDA Warning Letters addressing Informed Consent inspection findings with of appropriate corrective and preventive actions (CAPAs), equipping clinical researcher with solutions to avoid common pitfalls and potential inspection findings.
Attendees were encouraged to share their experiences, methods and tools used to aid in compliance through appropriate techniques for the Informed Consent process. Tools are provided to assist in compliance.
Learning Objectives:
- Critically assess the number of current critical inspection findings related to the ICF procedure.
- Prevent critical inspections findings related to informed consent procedure.
- Take appropriate corrective action to resolve critical inspection findings related to the informed consent procedure.
Agenda:
- 5:30 –6:00 pm – Registration & Networking
- 6:00 – 7:15 pm – Educational Presentation
- 7:15 – 8:00 pm – Q&A/Discussion
Target Audience: Investigator, Compliance/Quality Assurance Officer, Study Coordinator (CRC), Monitor/Clinical Research Associate (CRA), Regulatory Affairs Professional, Trainer/Educator, Investigator, Research Nurse, Auditor
1.5 Contact hours have been approved through ACRP. Membership is not required for online registration/application of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the registration desk and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate. After 30 days, contact hours are no longer available.