ICH GCP E6 (R2)

Question 1

What is Good Clinical Practice (GCP)?

Answer 1

An international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

Question 2

What does compliance with GCP assure?

Answer 2

1) The rights, safety, well-being, and confidentiality of subjects are protected
2) Trial data are credible and accurate

Question 3

GCP applies to all participants in the conduct of clinical trials, including:

Answer 3

1) Investigators
2) Monitors
3) Sponsors
4) IRBs

Question 4

The ICH E6(R2) GCP Integrated Addendum provides a unified standard to facilitate the mutual acceptance of data from trials by regulatory authorities in which countries?

Answer 4

EU
Japan
US
Canada
Switzerland

Question 5

How does ICH GCP define direct access?

Answer 5

Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial.

Question 6

How does ICH GCP define essential documents?

Answer 6

Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced

These documents serve to demonstrate compliance of the investigator, sponsor, and monitor with standards of GCP and with all applicable regulatory requirements.

Question 7

How does ICH GCP define an Independent Data Monitoring Committee?

Answer 7

A committee that may be established by the sponsor to assess the progress, safety data, and efficacy endpoints of a trial to recommend whether to continue, modify or stop a trial.

Question 8

How does ICH GCP define vulnerable subjects?

Answer 8

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits or of a retaliatory response from senior members of a hierarchy
Includes: students, subordinate employees of a hospital/lab/pharma, armed forces members, persons kept in detention, persons in nursing homes, unemployed or impoverished persons, ethnic minority groups, homeless persons, nomads, refugees, minors, patients with incurable disease, patients in emergency situations, and those incapable of giving consent

Question 9

How does ICH GCP define a certified copy?

Answer 9

A copy of the original record that has been verified (by dated signature or generation through a validated process) to have the same info as the original

Question 10

When reviewing payments to a subject, the IRB/IEC should assure that both the ________ and _________ of payment will not present a problem of coercion or undue influence.

Answer 10

Amount

Method

Question 11

Payments to subjects should be _________ and not contingent on ____________ of the trial by the subject.

Answer 11

Prorated

Completion

Question 12

When can an investigator implement a deviation in the protocol without prior IRB/IEC approval?

Answer 12

To eliminate an immediate hazard(s) to trial subjects

Question 13

If an investigator implements a protocol deviation without IRB approval to eliminate an immediate hazard to trial subjects, who should be notified as soon as possible?

Answer 13

1) The IRB/IEC
2) The Sponsor
3) Regulatory authorities

Question 14

At trial sites, the responsibility for IP accountability rests with whom?

Answer 14

The investigator

Question 15

Upon completion of the trial, the INVESTIGATOR should provide the ___________ and the ___________ ____________ with a final report summarizing the trials outcome.

Answer 15

IRB

Regulatory authorities

Question 16

To ensure that systems are designed to permit data changes in a way that the changes are documented and there is no deletion of data, they should use _________ _________.

Answer 16

audit trails

Question 17

How long should the SPONSOR retain essential trial documents?

Answer 17

1) 2 years after formal discontinuation of clinical development of an investigational product
2) 2 years after the last approval of a marketing application in an ICH region and until there are no pending marketing applications in an ICH region

Question 18

Who is responsible for ensuring that trials are adequately monitored & appointing monitors?

Answer 18

The Sponsor

Question 19

A monitor should submit a written report to the ____________ after each trial-site visit or trial-related communication.

Answer 19

Sponsor

Question 20

If monitoring or auditing finds serious and/or persistent noncompliance on the part of an investigator, the sponsor should ___________ the investigator’s trial participation and promptly notify ____________ ___________.

Answer 20

Terminate

Regulatory Authorities

Question 21

The SPONSOR should ensure that clinical trial reports are provided to ____________ _________ when a trial is completed or prematurely terminated.

Answer 21

Regulator agencies

Question 22

A final close-out of a trial can only be done when the monitor has reviewed both _____________ and ___________ files and confirms that all necessary documents are filed.

Answer 22

Investigator

Sponsor

Question 23

What is an Investigator’s Brochure (IB)?

Answer 23

A compilation of clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in humans.

It provides the Investigators with an understanding of possible risks and adverse reactions and facilitates their compliance with dosing and safety monitoring procedures

Question 24

For a marketed product, what might be an appropriate alternative to an IB?

Answer 24

An information brochure, package insert, or labelling

Question 25

How often should an IB be reviewed and revised?

Answer 25

Reviewed at least annually

Revised as necessary in compliance with sponsor’s written procedures

Question 26

Sponsors are responsible for providing an up-to-date IB to ___________, and Investigators are responsible for providing up-to-date IB to the __________.

Answer 26

Investigators

IRB/IEC