ACRP CCRP - ICH E6(R3) with complete updated
questions & answers
What is ICH E6(R3)? - answer Guideline for Good Clinical Practice, V3,
adopted 06Jan25
Two types of monitoring - answer 1. Investigator Site Monitoring
2. Centralized Monitoring
Centralized Monitoring - answer Evaluation of accumulated data; can
help identify systemic or site-specific issues
Investigator Site Monitoring - answer Monitoring clinical trial activities
at the investigator sites; may be on-site or remote
4 Monitoring Activities - answer 1. Communication with parties
conducting the trial
2. Investigator site selection, initiation, management, and close-out
3. Monitoring of investigational product management
4. Monitoring of clinical trial data
What are the 11 ICH E6(R3) principles? - answer 1. Ethical principles
2. Informed consent
, 3. IRB/IEC Review
4. Science
5. Qualified individuals
6. Quality
7. Risk Proportionality
8. Protocol
9. Reliable results
10. Roles and responsibilities
11. Investigational product
Describe the ethical principle of ICH E6(R3) - answer Clinical trials
should be designed and conducted in ways that ensure the rights,
safety, and well-being of the participants. Ethical principles that have
their origins in the Declaration of Helsinki.
Describe the Informed Consent principle of ICH E6(R3) - answer Clinical
trial participation is voluntary and based on a consent process that
ensures participants are well-informed. Information during consent
should be clear and concise and understandable.
Describe the IRB/IEC principle of ICH E6(R3) - answer Clinical trials
should be subject to an independent review by an IRB/IEC prior to
starting the trial and periodic reviews.
questions & answers
What is ICH E6(R3)? - answer Guideline for Good Clinical Practice, V3,
adopted 06Jan25
Two types of monitoring - answer 1. Investigator Site Monitoring
2. Centralized Monitoring
Centralized Monitoring - answer Evaluation of accumulated data; can
help identify systemic or site-specific issues
Investigator Site Monitoring - answer Monitoring clinical trial activities
at the investigator sites; may be on-site or remote
4 Monitoring Activities - answer 1. Communication with parties
conducting the trial
2. Investigator site selection, initiation, management, and close-out
3. Monitoring of investigational product management
4. Monitoring of clinical trial data
What are the 11 ICH E6(R3) principles? - answer 1. Ethical principles
2. Informed consent
, 3. IRB/IEC Review
4. Science
5. Qualified individuals
6. Quality
7. Risk Proportionality
8. Protocol
9. Reliable results
10. Roles and responsibilities
11. Investigational product
Describe the ethical principle of ICH E6(R3) - answer Clinical trials
should be designed and conducted in ways that ensure the rights,
safety, and well-being of the participants. Ethical principles that have
their origins in the Declaration of Helsinki.
Describe the Informed Consent principle of ICH E6(R3) - answer Clinical
trial participation is voluntary and based on a consent process that
ensures participants are well-informed. Information during consent
should be clear and concise and understandable.
Describe the IRB/IEC principle of ICH E6(R3) - answer Clinical trials
should be subject to an independent review by an IRB/IEC prior to
starting the trial and periodic reviews.
