ComplianceOnline

The ICF Process: Tips on Achieving Optimal compliance and Comprehension

Instructor: Kimberly Kiner
Product ID: 701686
  • Duration: 44 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Sep-2010

Training CD

$450.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This ICF process Webinar training teaches how to create an informed consent process for achieving optimal site compliance and subject comprehension. It also discusses how an inadequate ICF can affect data integrity and patient safety and/or well-being.

Why Should You Attend:

The ICF process, which involves communication between a consentee (patient/subject) and a consenter (staff clinician/designee), is a vital component to the authorization of any medical intervention or clinical research trial.
IRBs, sponsors and clinical sites all share the responsibility of ensuring an adequate ICF process. Any inadequate ICF training to clinical sites and /or unclear communication regarding the ICF content to potential subjects can result in detrimental consequences to the process that can ultimately affect data integrity and patient safety and/or well-being.

This session will discuss the issues and consequences surrounding an inadequate informed consent process and provide tips on how to create an informed consent process that achieves optimal site compliance and subject comprehension.

Areas Covered in the Seminar:

  • The definition of the “Informed Consent Process” per regulations.
  • The ethical standards surrounding the informed consent process .
  • The roles of parties responsible for an adequate ICF process per FDA regulations.
  • Barriers that affect subjects’ comprehension to the essential elements of the Informed Consent.
  • The most common deficiencies noted in the Informed consent Process.
  • The effects and consequences of an “inadequate” informed consent process.
  • Tips on how to achieve site compliance and ensure subject comprehension to the ICF process.

Who Will Benefit:

This webinar will provide valuable information to personnel in Sponsor Companies (i.e., Pharmaceutical, Biotechnology, Medical Device, etc.) as well as CROs and investigator sites conducting clinical trials including:

  • Clinical Research Associates
  • Study Managers
  • Site Staff/ Study Coordinators
  • Clinical Investigators

Instructor Profile:

Kimberly Kiner,BSc, CCRA is the President of 2K Clinical Consulting, Inc. a niche provider that focuses on simplifying trial management by providing monitoring and co-monitoring services to sponsor companies, CROs and sponsor-investigators. She has 13+ years of experience in the regulatory/ quality assurance and clinical research industry. She started her career at USFDA as a GMP FDA investigator and transitioned into the GCP industry working for Quintiles (CRO) and sponsor companies such as Johnson & Johnson, Berlex Laboratories (now Bayer), Galderma and others. She has held many positions over the years such as in-house CRA, Regional CRA, Sr. CRA and Independent CRA Consultant and has been involved in projects as a GCP Auditor and Trainer.

She has diverse experience in therapeutic areas of Cardiovascular, CNS, Medical devices, InVitro diagnostics, Infectious Diseases, Gastroenterology, Endocrinology and Women’s Health. Mrs. Kiner is certified and an active member of ACRP (Association of Clinical Research Professionals).

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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