Informed Consent in Clinical Research Training | CRC Course
Informed Consentin Practice
Seven modules on consent as a conversation: preparing for it, conducting it, checking that it was understood, and documenting it so the record holds up.
Studied within the Clinical Research Coordinator track. One payment of $249 USD covers all eight courses and the certificate.
Modules
7
Lessons
28
Knowledge checks
7
Study time
~about 11h
Final exam50 questions · 80% to pass · 75 minutes · up to 3 attemptsICH E6(R3)Intermediate
Consent is where a coordinator’s skill bears most directly on a participant’s welfare, and this course treats it as a conversation, not a signature.
What you will be able to do
01Conduct informed consent discussions that balance regulatory compliance with genuine participant comprehension and autonomous decision-making
02Apply ICH E6(R3) Annex 1, Section 2.8 informed consent requirements in their entirety, including the 20+ required elements
03Assess participant comprehension using validated techniques and adapt the consent conversation when comprehension gaps are identified
04Navigate consent requirements for special populations including pediatric participants, cognitively impaired adults, and participants in emergency settings
05Manage reconsent processes triggered by protocol amendments, new safety information, and ongoing consent obligations
06Document the consent process with sufficient detail to demonstrate compliance during monitoring and inspection
Seven modules,one final exam.
The course follows the encounter in order: its ethical ground, the preparation, the conversation, the check on understanding, special populations, reconsent, and the record.
A knowledge check closes every module
FreeTwo lessons are open to read now
Pass the final exam at 80% to complete the course
IThe Ethical and Regulatory Foundations of Consent4 lessons · knowledge check
1.1From Nuremberg to E6(R3): The Ethical Imperative Behind Informed Consent
1.2
Read two lessonsbefore you enroll.
Both are open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Module II · Lesson 222 min
The Consent Environment: Privacy, Time, and Freedom from Coercion
Covers the physical, temporal, and psychological requirements for a valid consent encounter, including privacy standards, scheduling for adequate time, and distinguishing coercion from appropriate motivation.
Walking Through the Consent Document: Pacing, Emphasis, and Plain Language
Teaches how to present consent document content using plain language, strategic pacing, and visual aids to maximize participant comprehension of complex clinical trial concepts.
Each point links back to its section of the guideline.
Studied as part ofthe CRC track.
Informed Consent in Practice is the fourth of eight courses in the Clinical Research Coordinator track. It is not sold on its own: one enrollment opens every course, every final exam and the certificate.
Clinical Research Coordinator
The coordinator’s work, taught course by course from site activation to archive, and grounded in ICH E6(R3).
Courses
8
Lessons
226
Study time
~100 h
Score 80% or higher on every final exam and your credential is issued, with the printable certificate included.
$249 USDOne payment for the whole track. Access does not expire.
How it is enrolled in, what the exam asks, and what you can read first.
Can I take this course on its own?
Not separately. Informed Consent in Practice is the fourth course in the Clinical Research Coordinator track, and the track is enrolled in as one: all eight courses, every final exam and the certificate, for one payment of $249 USD.
What does the final exam ask?
Fifty questions in 75 minutes, with 80% needed to pass, and up to three attempts. Each module also closes with a knowledge check.
Can I read any of it before I enroll?
Yes. Two lessons are open now: one on the consent environment, and one on walking a participant through the consent document.
Is it aligned to ICH E6(R3)?
Yes. The course works from ICH E6(R3), and covers the informed consent requirements of Annex 1, section 2.8 in full.
Does course access expire?
Learn consent as a conversation,within the CRC track.
One enrollment opens all eight courses, every final exam and the certificate. Course access does not expire.
No. Access is yours for good. The CRC credential the track awards is valid for two years.
$29 USD
of $249 USD
Can I take this course on its own?
Not separately. Informed Consent in Practice is the fourth course in the Clinical Research Coordinator track, and the track is enrolled in as one: all eight courses, every final exam and the certificate, for one payment of $249 USD.
Can I read any of it before I enroll?
Yes. Two lessons are open now: one on the consent environment, and one on walking a participant through the consent document.
Read two lessonsbefore you enroll.
Both are open now, exactly as enrolled learners read them. Every lesson in the course is written, cited and narrated the same way.
Module II · Lesson 222 min
The Consent Environment: Privacy, Time, and Freedom from Coercion
Covers the physical, temporal, and psychological requirements for a valid consent encounter, including privacy standards, scheduling for adequate time, and distinguishing coercion from appropriate motivation.
Walking Through the Consent Document: Pacing, Emphasis, and Plain Language
Teaches how to present consent document content using plain language, strategic pacing, and visual aids to maximize participant comprehension of complex clinical trial concepts.
