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Weekly GCP Challenge

Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.


Challenge: ICH GCP - Section One

Question Number 1:
Which of the following is the ICH GCP Glossary Definition of an Investigator?
A
 A person accountable for the subjects, the investigational product, the team of individuals and the adherence to the relevant guidelines and (local) regulatory requirements at a trial site.
B
 The inidividual responsible for all trial related activities at a trial site.
C
 The individual responsible for the conduct of the trial, the welfare of trial subjects and the investigational product at a trial site.
D
 A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator.

Question Number 2:
Which of the following is the ICH GCP Glossary Definition of Trial Related Compliance?
A
 Non-deviation from the protocol.
B
 Adherence to all the trial-related requirements, Good Clinical Practice (GCP) requirements, and the applicable regulatory requirements.
C
 Adherence to Good Clinical Practice (GCP), Good Manufacturing Practice (GMP) and all protocol related requirements.
D
 Non-deviation from the trial protocol and all applicable regulatory requirements.

Question Number 3:
Which of the following is the ICH GCP Glossary Definition of a Monitoring Report?
A
 A written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor’s SOPs.
B
 A document detailing the trial related compliance of a trial site compiled by a monitor following each site visit or trial related communication.
C
 A written report of the conduct, compliance and progress of a trial site compiled by a monitor following each site visit.
D
 An approved report from the site monitor of all relevant information relating to adherence to the protocol, GCP and, if applicable, local regulatory requirements after each site visit.

Question Number 4:
Which of the following is the ICH GCP Glossary Definition of a Protocol Amendment?
A
 All changes to a protocol that will impact on the inclusion, dosing, recording or follow-up of trial subjects
B
 Any change(s) to a protocol that will result in change(s) to the inclusion, dosing, recording or follow-up of trial subjects.
C
 Change(s) to a protocol that will result in change(s) to conduct of the trial.
D
 A written description of a change(s) to or formal clarification of a protocol

Question Number 5:
Which of the following is the ICH GCP Glossary Definition of a Trial Site?
A
 The primary location where trial related activities are conducted.
B
 The location(s) where trial-related activities are actually conducted.
C
 The location of the legal entity contracted to the sponsor for trial related activities.
D
 The location from which the investigator is ultimately employed or contracted.

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