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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: GCP Challenge 52

Question Number 1:
According to ICH GCP Section 2: The Principles of GCP which of the following is not one of the 13 stated priniciples?
A
 A clinical trial should be conducted using the smallest number of trial subjects considered adequate to provide a robust and accurate answer to the trial objectives.
B
 The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).
C
 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.
D
 A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

Question Number 2:
ICH GCP Section 5.2: Any trial related duties and functions not specifically transferred to and assumed by a CRO are what?
A
 to be documented to clearly state the responsibility
B
 to be defined in a contract between CRO and Sponsor
C
 transferred to the CRO
D
 retained by the sponsor

Question Number 3:
Section 5.18 of ICH GCP: Which of the following is not specified as a responsibility of a monitor?
A
 reporting the subject recruitment rate
B
 determining whether all adverse events are appropriately reported
C
 acting as a main line of communication between sponsor and investigator
D
 acting as a main line of communication between the investigator and the IRB/IEC

Question Number 4:

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

"Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products"
A
 Local Regulatory Requirements
B
 Applicable Regulatory Requirements
C
 Applicable Legislation
D
 Local Legislation

Question Number 5:

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 6:

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

Question Number 7:
In the EU who is responsible for conducting GCP inspections?
A
 The sponsor
B
 The EMEA
C
 Member States' Competent Authorities
D
 Ethics Committees

Question Number 8:
Which event precipitated the production of the Nuremberg Code?
A
 The elixir of sulphanilimide incident
B
 Trials of war criminals following the second world war
C
 The Tuskegee syphilis studies
D
 The Belmont report

Question Number 9:

What is the answer to the following equation:

The usual percentage confidence interval used to report results in a clinical trial minus the generally accepted minimum power level for a clinical trial.
A
 35%
B
 30%
C
 20%
D
 15%

Question Number 10:
According to CFR21 and ICH GCP which must have a maximum of 18 members?
A
 IRB only
B
 IEC only
C
 Both IRB and IEC
D
 Neither

Question Number 11:
What was the date of the 59th WMA meeting at which a new version of the Declaration of Helsinki agreed?
A
 May 2008
B
 July 2008
C
 Sept 2008
D
 Oct 2008

Question Number 12:
In the Canadian Food and Drug Regulations what does REB stand for?
A
 Regulatory Enquiry Bureau
B
 Research Ethics Board
C
 Requirements for Environmental Benefit
D
 Research Environment Bureau

Question Number 13:

Which of the following would be classed as surrogate endpoints?

1) Time to death

2) Reduction in LDL cholesterol

3) Increase in specific antibody level in testing a new vaccine

4) Relief of pain at 2 hours post dose
A
 1 only
B
 1 and 2 only
C
 2 and 3 only
D
 3 and 4 only

Question Number 14:

If you considered that the new product that you were testing was probably as effective as the chosen comparator but may be a little better which would be the most suitable form of trial?
A
 non-comparative
B
 superiority
C
 equivalence
D
 non-inferiority

Question Number 15:

If you had a block size of 6. Two treatment groups A and B. The randomisation was a ratio of 2 to 1 with 2 in A and 1 in B. What would be the next two letters in the randomisation sequence following this:

AAAABBBAAB..?
A
 AA
B
 AB
C
 BA
D
 BB

Question Number 16:
What would you most likely see Propofol used for?
A
 Tumour size reduction
B
 Anesthesia
C
 Prevent transplantation rejection
D
 Bronchodilation

Question Number 17:

Which of the following is not a sub-section of section 4 (Investigator) of ICH GCP?
A
 Adequate Resources
B
 Randomisation Procedures and Unblinding
C
 Premature Termination or Suspension of a Trial
D
 Medical Expertise

Question Number 18:
What of the following international guidelines was updated in October 2008?
A
 ICH GCP
B
 Declaration of Helsinki
C
 Nuremberg Code
D
 CIOMS/WHO guidelines

Question Number 19:
E - According to the 2008 update to 21CFR 312 what does E stand for in IEC ?
A
 Ethics
B
 Environmental
C
 Essential
D
 Elective

Question Number 20:
O - What O should be included in a protocol according to section 6.3 of ICH GCP?
A
 Organisation
B
 Obligations
C
 Operational aspects
D
 Objectives

Question Number 21:
L - What is a Latin Square?
A
 A method of blinding where both products are changed to look like the opposite treatment
B
 A type of trial design used when several products are to be tested
C
 A statistical result which shows that the opposite result has been acheived from that which was expected
D
 A type of dance

Question Number 22:

The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard without prior IRB/IEC approval/favourable opinion. As soon as possible what should be submitted to the IRB/IEC, the Sponsor and if applicable the Regulatory Authority(ies)?

1) the implemented deviation

2) the reasons for the deviation

3) if appropriate the proposed protocol amendment
A
 1 only
B
 1 and 3 only
C
 1 and 2 only
D
 All of them

Question Number 23:

What do you get if you combine the following:

1. The first letter of the title of section 7 of GCP

2. The first initial of international, nongovernmental, not-for-profit organization established jointly by WHO and UNESCO in 1949 to facilitate and promote international activities in the field of biomedical sciences

3. The first letter of the name of the city associated with a set of ethical principles for conducting human experimentation.
A
 SOP
B
 GCP
C
 IMP
D
 ICH

Question Number 24:
What word is missing from this ICHGCP definition of the protocol?: A document that describes the objective(s), design, statistical consderations, and organization of a trial.
A
 written
B
 methodology
C
 clinical
D
 No word is missing

Question Number 25:
Which of the following is most true concerning advertisements for subject recruitment?
A
 They should not be used
B
 They can be used provided the investigator approves them
C
 They can only be used if the Ethics Committee approves them
D
 Paper advertisements can be used but not radio or TV advertisements

Question Number 26:

Which of the following is not listed as one of the subjects that written informed consent should include explanations of?
A
 The foreseeable circumstances and/or reasons under which the subjects participation in the trial may be terminated
B
 The reasonably foreseeable risksor inconveniences to the subject and when applicable to an embryo, fetus, or nursing infant
C
 The alternative procedure or courses of treatment that may be available to the subject and their important potential benefits and risks
D
 The qualifications of the investigator and if applicable a statement of any non-trial related payments made by, either directly or indirectly, the sponsor to the investigator.

Question Number 27:
Who is responsible for creating the TMF?
A
 Sponsor
B
 Investigator
C
 Both
D
 Neither

Question Number 28:
The following disguised image is the logo from which Regulatory Agency?
A
 EMEA
B
 FDA
C
 MHRA
D
 TGA

Question Number 29:

Who is this?
A
 Dennis Gillings - Founder of Quintiles
B
 Frank Torti - Commissioner of FDA
C
 Sir David Cox - Statistician famous for the Cox Proportional Hazards Analysis
D
 Jeffrey Kindler - CEO of Pfizer

Question Number 30:
A subject experiences a bereavement during a clinical trial, what circumstances would make it advisable to report this event?
A
 The subject withdraws from the study but doesn't wish to give a reason
B
 The subject experiences clinical depression following the bereavement
C
 It should be reported as an adverse event in any case
D
 It should never be reported

Question Number 31:
What was the biggest selling pharmaceutical product in the world in 2006 and 2007?
A
 Zantac
B
 Lipitor
C
 Herceptin
D
 Nexium

Question Number 32:
In ICH GCP what is the difference between an Adverse Event and an Adverse Drug Reaction?
A
 An Adverse Drug Reaction is related to the IMP but an Adverse Event is not
B
 There is no difference
C
 An Adverse Drug Reaction is a response to the IMP and an Adverse Event may or may not be a response to the IMP
D
 An Adverse Event is reported in a clinical trial and an Adverse Drug Reaction is the term used in pre-clinical research

Question Number 33:
What does CIOMS stand for?
A
 Critical International Operational Medical Standards
B
 Council for International Organisations of Medical Science
C
 Clinical Investigation of Orphan Medicinal Substances
D
 Central International Office of Medical Standards

Question Number 34:
What does DSMB stand for?
A
 Drug Safety Medical Benchmark
B
 Data Standards for Medicinal Biology
C
 Data Safety Monitoring Board
D
 Drug Sciences Monitoring Bureau

Question Number 35:
What would you expect to see treated with the following: Sibutramine?
A
 Leg Ulcers
B
 Obesity
C
 Ulcerative Colitis
D
 Sleep apnoea

Question Number 36:
Which route of administration would include an injection to the cheek from within the mouth?
A
 AURICULAR
B
 ENTERAL
C
 BUCCAL
D
 INTRABURSAL

Question Number 37:
Ciba-Geigy and Sandoz Laboratories merged in 1996 to form which company?
A
 Sanofi
B
 Novartis
C
 Chugai
D
 Bayer

Question Number 38:

Which of the following is true about the statement below:

"It is recommended that the investigator inform the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed."
A
 It is contained in section 4 of ICH GCP
B
 It is not referred to in ICH GCP
C
 It is contained in section 2 of ICH GCP
D
 It is contained in ICH E1

Question Number 39:
According to ICH GCP the information for the subject should include: The trial treatment(s) and the probability for xxxxxxxx
A
 Adverse Drug Reactions
B
 efficacy
C
 random assignment to each treatment
D
 withdrawal of the subject from the trial

Question Number 40:
In ICH GCP which of the following is NOT listed under monitor's responsibilities
A
 Verifiying that the investigator is enroling only eligible subjects
B
 Verifying that written informed consent was obtained
C
 Verifying that consent was obtained by a physician
D
 Reporting the subject recruitment rate

Question Number 41:

Which of the following statements are contained in ICH E6: GCP

  1. In blinded trials, the coding system for the investigational product(s) should include a mechanism that permits rapid identification of the product(s) in case of a medical emergency, but does not permit undetectable breaks of the blinding.
  2. If the trial is blinded, the investigator should promptly document and explain to the sponsor any premature unblinding.
  3. Care should be taken to choose block lengths that are sufficiently short to limit possible imbalance, but that are long enough to avoid predictability towards the end of the sequence in a block. Investigators and other relevant staff should generally be blind to the block length.
A
 1 only
B
 1 and 2 only
C
 2 and 3 only
D
 All of them

Question Number 42:

Which of the following statements are contained in ICH E6: GCP

  1. In conducting a controlled trial, randomised allocation is the preferred means of assuring comparability of test groups and minimising the possibility of selection bias.
  2. Methods used to evaluate patient usage of the test drug should be specified in the protocol and the actual usage documented.
  3. In general, women of childbearing potential should be using highly effective contraception to participate in clinical trials
A
 1 only
B
 2 only
C
 3 only
D
 None of them

Question Number 43:

Which of the following statements are contained in ICH E6: GCP?

  1. The investigator should ensure the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor in the CRFs and in all required reports.
  2. The primary variable (target variable, primary endpoint) should be the variable capable of providing the most clinically relevant and convincing evidence directly related to the primary objective of the trial.
  3. Data reported on the CRF, that are derived from source documents, should be consistent with the source documents or the discrepancies should be explained.
A
 1 only
B
 2 and 3 only
C
 1 and 3 only
D
 None of them

Question Number 44:
According to ICH GCP the investigator "should be qualified by....."?
A
 training and experience
B
 education, training and experience
C
 education and experience
D
 education and training

Question Number 45:
According to ICH GCP the investigator should be "able to demonstrate........"?
A
 Knowledge of GCP
B
 That all persons involved in the study have been appropriately trained
C
 A potential for recruiting the required number of subjects within the agreed recruitment period
D
 Understanding of the protocol

Question Number 46:
Which of the following is the odd one out?
A
 Ketamine
B
 Propofol
C
 Etomidate
D
 Desvenlafaxine

Question Number 47:
According to ICH GCP chapter 8 what is the purpose of filing the CV of the investigator?
A
 To document who is acting as investigator
B
 To document qualifications, education and training of the investigator
C
 To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects
D
 There is no requirement to file the investigator's CV

Question Number 48:

According to ICH E8 what Type of Study would the following be?

  • Dose-tolerance studies
  • Single and multiple dose PK and/or PD studies
  • Drug interaction studies
A
 Human Pharmacology
B
 Therapeutic Exploratory
C
 Therapeutic Confirmatory
D
 Therapeutic Use

Question Number 49:

ICH E8 states:

"The study protocol should have a XXXXXXXX that is appropriate for the objectives and design of the study, taking into account the method of subject allocation, the measurement methods of response variables, specific hypotheses to be tested, and analytical approaches to common problems including early study withdrawal and protocol violations."

What is missing from the statement?
A
 detailed statistical section
B
 specified analysis plan
C
 statistical analysis plan
D
 section

Question Number 50:
What does IMPD stand for?
A
 Investigational Medicinal Product Dossier
B
 Investigator Medical Personnel Designate
C
 International Medical Protocol - Draft
D
 Intravenous Medicines - Protocol for Delivery

Question Number 51:

You have designed a parallel group clinical trial that requires more subjects than you have budget for. Which of the following options (subject to certain limitations based on therapeutic area and indication) could help reduce your required sample size?

a) change to a cross over trial

b) reduce the expected difference between treatments

c) refine the entry criteria to reduce outcome variance

d) reduce the power of the trial
A
 a and b only
B
 a, b and c only
C
 a, b and d only
D
 a, c and d only

Question Number 52:
Which role is responsible for assuring compliance of the clinical trial with GCP and the protocol?
A
 CRA
B
 Investigator
C
 Auditor
D
 All of the above

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