Prime Site Academy
ICH E6(R3) aligned

Informed Consent in Clinical Trials

Run a consent discussion participants really understand, handle re-consent and new form versions, and document consent the way monitors expect to see it.

  • 10 video lessons
  • About 2 h 40 min
  • 3 module quizzes
  • Certificate of completion

What you'll be able to do

  • Explain every required element of consent to a participant, in plain language
  • Handle re-consent, new form versions and legally authorized representatives correctly
  • Document consent the way monitors expect, and avoid the most common audit findings

Curriculum

3 modules · 10 lessons · 3 quizzes

Module 1 · Foundations

Free during trial
  1. 01

    Why consent exists: Nuremberg to the Belmont Report

    8 min
  2. 02

    Respect for persons, beneficence and justice at the site

    9 min
  3. 03

    Capacity, comprehension and voluntary choice

    8 min
  4. 04

    Consent is a process, not a signature

    7 min
  5. Module quiz · pass with 80% · unlimited retakes

Module 2 · Regulatory requirements

  1. 05

    Required elements of consent

    21 CFR 50.25 · 45 CFR 46.116

    12 min
  2. 06

    The investigator's consent duties under ICH E6(R3)

    10 min
  3. 07

    IRB-approved versions, amendments and re-consent

    11 min
  4. Module quiz · pass with 80% · unlimited retakes

Module 3 · At the site

  1. 08

    Running the discussion: teach-back, LARs, witnesses and translated forms

    14 min
  2. 09

    Documenting consent correctly

    21 CFR 50.27 · source notes

    10 min
  3. 10

    Common monitor and audit findings, and how to prevent them

    13 min
  4. Module quiz · pass with 80% · unlimited retakes
RH

Taught by Dr. Ruby Hussain, MD

Principal Investigator at Prime Global Research, 50+ trials since 2019. Started as a CRA, so she knows both sides of the monitoring visit.