ICH Harmonised Guideline for Good Clinical Practice E6 (R2) Flashcards
When was the ICH guideline finalized under step 4
November 2016
The guidance was developed with consideration of the current good clinical practices of the
_________________________________
European Union, Japan, and the United States, as well as those of Australia, Canada, the
Nordic countries, and the World Health Organization.
What is
E2A
E3
E7
E8
E9
E11
Clinical safety data management
clinical study reporting
geriatric populations
General considerations for clinical trials
Statistical principles
pediatric populations
This ICH GCP Guidance Integrated Addendum provides a unified standard for the ____________________ to facilitate the mutual acceptance
of data from clinical trials by the regulatory authorities in these jurisdictions.
European
Union, Japan, the United States, Canada, and Switzerland
In the event of any conflict between the E6(R1) text and the E6(R2) addendum text, the ______ addendum text should take priority.
E6(R2)
What are the principles of ICH GCP
2.l Clinical trials should be conducted in accordance with the ethical principles that
have their origin in the Declaration of Helsinki, and that are consistent with GCP
and the applicable regulatory requirement(s).
2.2 Before a trial is initiated, foreseeable risks and inconveniences should be weighed
against the anticipated benefit for the individual trial subject and society. A trial should
be initiated and continued only if the anticipated benefits justify the risks.
2.3 The rights, safety, and well-being of the trial subjects are the most important
considerations and should prevail over interests of science and society.
2.4 The available nonclinical and clinical information on an investigational product
should be adequate to support the proposed clinical trial.
2.5 Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
2.6 A trial should be conducted in compliance with the protocol that has received prior
institutional review board (IRB)/independent ethics committee (IEC)
approval/favorable opinion.
2.7 The medical care given to, and medical decisions made on behalf of, subjects
should always be the responsibility of a qualified physician or, when appropriate, of
a qualified dentist.
2.8 Each individual involved in conducting a trial should be qualified by education,
training, and experience to perform his or her respective task(s).
2.9 Freely given informed consent should be obtained from every subject prior to
clinical trial participation.
2.10 All clinical trial information should be recorded, handled, and stored in a way that
allows its accurate reporting, interpretation, and verification.
ADDENDUM
This principle applies to all records referenced in this guidance, irrespective of the type of
media used.
2.11 The confidentiality of records that could identify subjects should be protected,
respecting the privacy and confidentiality rules in accordance with the applicable regulatory
requirement(s).
2.12 Investigational products should be manufactured, handled, and stored in accordance with
applicable good manufacturing practice (GMP). They should be used in accordance with the
approved protocol.
2.13 Systems with procedures that assure the quality of every aspect of the trial should
be implemented.
T or F: An IRB/IEC should safeguard the rights, safety, and well-being of all trial
subjects. Special attention should be paid to trials that may include vulnerable
subjects.
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The IRB/IEC should obtain the following documents:
- Trial Protocol amendments
- ICF and ICF updates
- Recruitment procedures
- Written info to be provided to subjects
- Investigational Brochure
- Safety Info
- Compensation
- Investigators CV
The IRB/IEC should review a proposed clinical trial within a reasonable time and
document its views in writing, clearly identifying the trial, the documents reviewed
and the dates for the following:
Approval/favorable opinion;
- Modifications required prior to its approval/favorable opinion;
- Disapproval/negative opinion; and
- Termination/suspension of any prior approval/favorable opinion.
The IRB/IEC should consider the qualifications of the investigator for the proposed
trial, as documented by ____________ and/or by any other relevant
documentation the IRB/IEC requests.
a current curriculum vitae
3.1.4 The IRB/IEC should conduct continuing review of each ongoing trial at intervals
appropriate to the degree of risk to human subjects, ____________
at least once per year
T or F: The IRB/IEC should review both the amount and method of payment to subjects to
assure that neither presents problems of coercion or undue influence on the trial
subjects. Payments to a subject should be prorated and not wholly contingent on
completion of the trial by the subject.
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The IRB/IEC should consist of a reasonable number of members, who collectively
have the qualifications and experience to review and evaluate the science, medical
aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should
include:
(a) At least five members.
(b) At least one member whose primary area of interest is in a nonscientific area.
(c) At least one member who is independent of the institution/trial site.
Only those IRB/IEC members who are independent of the investigator and the sponsor
of the trial should vote/provide opinion on a trial-related matter.
A list of IRB/IEC members and their qualifications should be maintained.
or f: Only members who participate in the IRB/IEC review and discussion should
vote/provide their opinion and/or advice.
t