ICH E6(R2)

Question 1

Good Clinical Practice (GCP)

Answer 1

an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects

Question 2

What document is the origin of trial subject protection

Answer 2

Declaration of Helsinki

Question 3

Objective of ICH GCP

Answer 3

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

Question 4

Why was the E6(R2) addendum created

Answer 4

To update E6(R1) for the electronic age (shift from all paper studies)

Question 5

clinical trials should be conducted in accordance with the ethical principles that have their origin in:

Answer 5

The Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirements

Question 6

a trial should be initiated only if . . .

Answer 6

the anticipated benefits justify the risks

Question 7

the rights, safety, and well-being of the trial subject are . . .

Answer 7

the most important considerations and should prevail over interests of science and society

Question 8

the available nonclinical and clinical information on an investigational product should be . . .

Answer 8

adequate to support the proposed clinical trial

Question 9

clinical trials should be

Answer 9

• -scientifically sound

- -described in a clear, detailed protocol

Question 10

a trial should be conducted in compliance with

Answer 10

the protocol that has received prior IRB/IEC approval

Question 11

the medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of

Answer 11

a qualified physician or, when appropriate, of a qualified dentist

Question 12

each individual involved in conducting a trial should be qualified by

Answer 12

education, training, and experience to perform his or her respective task(s)

Question 13

What should be obtained from every subject prior to clinical trial participation

Answer 13

freely given informed consent

Question 14

all clinical trial information should be recorded, handled, and stored in a way that allows

Answer 14

its accurate reporting, interpretation, and verification

Question 15

investigational products should be manufactured, handled, and stored in accordance with

Answer 15

applicable good manufacturing practice (GMP)

Question 16

IRB/IEC should . . .

Answer 16

safeguard the rights, safety, and well-being of all trial subjects. Special attention should be paid to trials that may include vulnerable subjects

Question 17

Documents that IRB/IEC should obtain

Answer 17

• -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.

Question 18

IRB/IEC continuing reviews should be conducted how often

Answer 18

at intervals appropriate to the degree of risk to human subjects, but at least once per year

Question 19

the IRB/IEC should review the amount and method of payment to subjects to assure that neither

Answer 19

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

Question 20

IRB/IEC should consist of

Answer 20

• -at least 5 members
• -at least 1 member from nonscientific area
• -at least one member independent of institution

Question 21

Investigators should promptly report to the IRB/IEC

Answer 21

• -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

Question 22

stopped on section 3.4 Records p. 12 Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice