ICH E6(R2) Flashcards
Good Clinical Practice (GCP)
an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects
What document is the origin of trial subject protection
Declaration of Helsinki
Objective of ICH GCP
to provide a unified standard for the EU, Japan, and the US to facilitate mutual acceptance of clinical data by the regulatory authorities in these jurisdictions
Why was the E6(R2) addendum created
To update E6(R1) for the electronic age (shift from all paper studies)
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 requirements
a trial should be initiated only if . . .
the anticipated benefits justify the risks
the rights, safety, and well-being of the trial subject are . . .
the most important considerations and should prevail over interests of science and society
the available nonclinical and clinical information on an investigational product should be . . .
adequate to support the proposed clinical trial
clinical trials should be
- -scientifically sound
- -described in a clear, detailed protocol
a trial should be conducted in compliance with
the protocol that has received prior IRB/IEC approval
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
each individual involved in conducting a trial should be qualified by
education, training, and experience to perform his or her respective task(s)
What should be obtained from every subject prior to clinical trial participation
freely given informed consent
all clinical trial information should be recorded, handled, and stored in a way that allows
its accurate reporting, interpretation, and verification
investigational products should be manufactured, handled, and stored in accordance with
applicable good manufacturing practice (GMP)
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
Documents that IRB/IEC should obtain
- -protocol/amendments
- -Informed consent forms and updates
- -subject recruitment procedures
- -written information provided to subjects
- -Investigator’s Brochure (IB)
- -available safety information
- -information about payments/compensation available to subjects
- -Investigator’s CV, etc.
IRB/IEC continuing reviews should be conducted how often
at intervals appropriate to the degree of risk to human subjects, but at least once per year
the IRB/IEC should review 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
IRB/IEC should consist of
- -at least 5 members
- -at least 1 member from nonscientific area
- -at least one member independent of institution
Investigators should promptly report to the IRB/IEC
- -deviations from/changes to protocol to eliminate immediate hazards to trial subjects
- -changes increasing risk to subjects or significantly affecting the conduct of the trial
- -all ADRs that are both serious and unexpected
- -new information that may affect adversely safety of subjects or conduct of trial
stopped on section 3.4 Records p. 12 Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice
