Training Courses - Core Cirriculum

Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.

Informed Consent - Beyond the Basics

Upcoming Courses

Course Description

This intensive course provides a detailed exploration of best practices surrounding the development of informed consent and patient educational materials as well as tools and methodologies for obtaining informed consent. Going beyond the minimum regulatory requirements, this course offers practical as well as theoretical information for enhancing the informed consent process.

Learning Objectives

  • Describe tools and techniques for communicating risk and benefits of clinical research trials
  • Explain methods for evaluating readability and understandability of informed consent/patient education materials
  • List various resources available to aid in developing more patient friendly consent forms
  • Discuss how to optimize the informed consent discussion

Who Should Attend

  • Principal Investigators and Sub-Investigators
  • Research Nurses and Study Coordinators
  • Project Managers/Directors
  • Recruitment Specialists

Instructor

Beth D. Harper, B.S., M.B.A.

Click here for complete trainer biographies

Course Outline

Day 1: 8:30 a.m. – 5:00 p.m.

  • Welcome and Introductions
  • Regulatory Recap – the Letter and Spirit of the Laws and Regulations
  • Common Consenting Challenges: Troubleshooting the Issues
  • Consent Development Best Practices: Messages and Materials to Ensure Understandability
  • Communication Best Practices: Strategy and Flow to Ensure Seamless Consent
  • Validating Knowledge Transfer: Ensuring the Message is Received
  • The Role of E-Consenting and Additional Resources for “Out of-the-Box” Consenting
  • Wrap-Up / Q & A / Departures

Interactive Activities

  • Evaluate readability of a sample document
  • Craft “important messages” using a sample protocol
  • Create a comprehension or knowledge validation “quiz”
  • Process map the “ideal” patient education flow

Registration Fees

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 Melissa Dolen at 781-972-5418 to discuss your options and take advantage of the savings.

Click here for our seminar cancellation policy

Accreditation Information

ACPE LogoBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE# 0778-0000-14-040-L01-P. Released 3/14.

Hold this course at your company!

For more information, contact Naila Ganatra at (215) 413-2471.