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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: Ultimate GCP II

Question Number 1:
According to ICH GCP where should the initiation visit report be filed
A
 Sponsor file only
B
 Investigator file only
C
 Both Sponsor and Investigator files
D
 Not specified

Question Number 2:
According to ICH GCP when, under normal circumstances, should the monitor visit the site?
A
 They don’t have to visit
B
 Before, during and after the study
C
 Every 4-6 weeks
D
 At least once

Question Number 3:
Which word(s) are missing from the following in the ICH GCP definition of an SOP: "Detailed, written instructions to achieve XXX of the performance of a specific function"
A
 quality
B
 reliability
C
 uniformity
D
 consistency

Question Number 4:
Which word(s) are missing from the following in ICH E9: "Details of the randomisation that facilitate predictability (e.g. block length) should not be XXX"
A
 made available to monitors
B
 available to operational personnel
C
 contained in the trial protocol
D
 revealed until database lock

Question Number 5:
According to ICH GCP which of the following is the odd one out in terms of where it/they should be filed?
A
 Audit Certificate
B
 Master Randomisation List
C
 Monitoring Visit Reports
D
 Subject Identification Code List

Question Number 6:
Complete this statement from ICH GCP: neither the investigator, nor the trial staff, should XXX or unduly influence a subject to participate or to continue to participate in a trial.
A
 convince
B
 coerce
C
 compel
D
 change the opinion

Question Number 7:
Which of the following does ICH GCP define as the purpose of a sponsors audit?
A
 To evaluate trial conduct and compliance with the protocol and other requirements
B
 To evaluate trial conduct and compliance with the protocol, SOPs, GCP and the applicable regulatory requirements
C
 To determine whether the appropriate regulations and guidelines are being followed correctly
D
 To ensure the integrity of the data and the safety of the trial subjects

Question Number 8:
Which of the following is NOT an ICH GCP requirement for clinical trial sites?
A
 Adequately trained staff
B
 Adequate facilities
C
 Experienced staff
D
 Study Site Co-ordinator

Question Number 9:
Which of the following is most true regarding the ICH GCP requirements for an investigator?
A
 They must be medically qualified
B
 They should be a physician or a dentist or there must be a medically qualified person on the site staff team
C
 They must be medically qualified or a dentist
D
 They must be medically qualified, a dentist or another healthcare professional

Question Number 10:
According to ICH GCP who is responsible for the content of the Patient Information Sheet?
A
 The sponsor
B
 The investigator
C
 The Ethics Committee
D
 The Monitor

Question Number 11:
Of what is this the ICH GCP definition: " prevention of disclosure, to other than authorised individuals, of a sponsor's proprietary information or of a subject's identity."?
A
 Data protection
B
 Source data verification
C
 Confidentiality
D
 Inspection

Question Number 12:
Of what is this part of the ICH GCP definition: "A unique identifier assigned by the investigator to each trial subject to protect the subject's identity"
A
 Randomisation code
B
 Code break
C
 Data protection clause
D
 Subject Identification Code

Question Number 13:
In ICH GCP who is responsible for submitting any required applications to the appropriate authority for review?
A
 Sponsor
B
 Investigator
C
 Ethics Committee
D
 Regulatory Authority

Question Number 14:
In ICH GCP who is reponsible for defining, establishing and allocating all trial related duties and functions?
A
 Sponsor
B
 Investigator
C
 Ethics Committee
D
 Regulatory Authority

Question Number 15:

According to ICH GCP what is the following the definition of?

"Biomedical Studies not performed on human subjects"
A
 Preclinical Study
B
 Non-interventional Study
C
 Phase 0
D
 Nonclinical Study

Question Number 16:

According to ICH GCP any trial related duty and function that is transferred to and assumed by a CRO should be what?
A
 Agreed and documented
B
 Documented in a contract or scope of work
C
 Done so only after the procedures of the CRO have been verified by audit
D
 Specified in writing

Question Number 17:

What completes the following statement form ICH GCP Section 4.9 regarding Essential Documents?

"The investigator/institution should take measures to prevent XXXXXXX destruction of these documents"
A
 Incorrect
B
 accidental or premature
C
 inappropriate
D
 unauthorised

Question Number 18:

What does ICH GCP state about how an investigator should be qualified?

"The Investigator should be qualified by.................."

1) Education

2) Training

3) Experience

Which of the above are missing from the statement?
A
 1 and 2 only
B
 2 and 3 only
C
 1 and 3 only
D
 1, 2 and 3

Question Number 19:

What does ICH GCP state about the investigator or trial staff persuading subjects to take part in a trial?

"Neither the investigator, nor the trial staff, should ................... a subject to participate or to continue to participate in a trial"
A
 persuade
B
 force
C
 coerce or unduly influence
D
 use inappropriate methods to influence

Question Number 20:

ICH GCP states what information and explanations should be provided to the subject prior to informed consent. Which of the following are included in this list?

1) The approximate number of subjects involved in the trial

2) The subject's responsibilities

3) That the trial involves research

4) The expected duration of the subject's participation in the trial
A
 All of them
B
 None of them
C
 1 and 2 only
D
 2 and 4 only

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