ComplianceOnline

Recruitment and Informed Consent: The Cornerstone of Ethical Clinical Research

Instructor: Jennifer Holcomb 
Product ID: 704289
  • Duration: 60 Min

recorded version

$229.00
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: May-2016

Training CD / USB Drive

$399.00
One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

At the end of this training program, participants will be able to differentiate between consent and assent, identify when to use the long form and when to use the short form, describe the consent process using best practices.

Why Should You Attend:

Whether you are a new clinician, or have years of experience, operationalizing best practices for recruitment and informed consent in research is a core skill that differs in many ways from clinical consent. You may know the regulations, but developing the mastery of effective evaluations of competency and understanding of study subjects and management of involvement of trusted others in a HIPAA compliant fashion are operational skills that improve your practice and your outcomes.

This webinar will provide a review of regulatory requirements and a comprehensive discussion of the “how-to” to develop best practices and sharpen your skills when engaging with potential study participants and their significant others. Determining when assent is needed, understanding how it differs from consent. Planning your approach, who should be involved in the discussion and when you should involve them? Documentation of consent, what is required and where should it be recorded.

The instructor’s extensive knowledge and experience in clinical research conduct, including special populations that require competency evaluations makes her well suited to answer your questions and offer guidance in the practice of recruitment and consent.

Areas Covered in the Webinar:

  • Elements of Informed Consent
  • HIPAA and Recruitment - Who Can You Approach and When
  • Consent Process and Key Milestones
  • Evaluation of Competence
  • Documentation of Consent- Long Form and Short Form
  • When Assent is Needed

Who Will Benefit:

  • Investigators
  • Coordinators
  • Health System Administrators
  • Clinical Research Compliance Staff/ Officers
  • Industry Managers and Monitors

Instructor Profile:

Jennifer Holcomb, MA, CCRC, is a clinical research professional with over 20 years of experience in the field. She is currently consulting privately. Ms. Holcomb has worked in nationally accrediting Institutions with AAHRPP. Her experience also includes serving in executive leadership roles at research institutions including Duke University, UCHealth System and University of Louisville. She provides guidance and leadership in the establishment and development of policies in the conduct and management of clinical research. Her key areas of expertise include clinical trial budgeting and contract negotiations as well as regulatory knowledge including international ICH GCP standards. Ms. Holcomb has extensive experience in training and education and served as Vice Chair of the ACRP Professional Development Committee for 4 years.

Topic Background:

Informed and involved study participants are empowered medical decision makers. They ensure the highest quality of data collected and successful study completion. To improve clinical research participation, participant retention and accuracy of data collected- we must begin with an investment in the recruitment and informed consent of our most valuable partners in clinical research, study subjects. Understanding the regulatory requirements is essential; operationalizing them is a skill.

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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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