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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: Clinical Research All-Rounder II

Question Number 1:
What word is missing from ICH GCP: Data reported on the CRF that are XXXX from source documents should be consistent with the source documents or the discrepancies should be explained.
A
 copied
B
 transcribed
C
 derived
D
 described

Question Number 2:
What completes the statement from ICH GCP: When using electronic trial data handling and/or remote electronic trial data systems the sponsor should maintain XXX for using these systems.
A
 SOPs
B
 Standards
C
 Specific Validation Records
D
 Security and Backup procedures

Question Number 3:
What year was the original ICH GCP finalised?
A
 1993
B
 1994
C
 1995
D
 1996

Question Number 4:
Which category of Adverse Event does this fall into: A patient develops a chest infection which requires antibiotic treatment but no hospitalisation. The investigator does not think it is drug related.
A
 Just an Adverse Event
B
 Serious Adverse Event
C
 SSAR
D
 SUSAR

Question Number 5:
If the non-inferiority limit for the difference in response rates of treatment A - treatment B is set at -10%. Which of the following results would suggest that A was not inferior to B.
A
 response rates A = 95% B=98% and p-value=0.01
B
 95% confidence interval for rates of A - B, lower limit=-12% upper limit=7%
C
 95% confidence interval for rates of A - B, lower limit=-8% upper limit=6%
D
 response rates A = 96% B=98% and p-value=0.11

Question Number 6:
What does GGT stand for?
A
 Gamme glutamyl transaminase
B
 Gamma glucose transferase
C
 Gamma glutamyl transferase
D
 Gamma glucose transaminase

Question Number 7:
Which of the following is NOT true of emergency code breaks at the investigational site?
A
 The reason for the break must be reported
B
 The code should be broken only for one subject at any one time
C
 Only the investigator can break the code
D
 The code should only be broken if essential for the subject's safety

Question Number 8:
Under GCP who has primary responsibility for the welfare of clinical trial subjects?
A
 Sponsor
B
 Ethics Committee
C
 Regulatory Authority
D
 Investigator

Question Number 9:
If your sample size calculations gave you a required figure of 1000 patients in the trial and this was considered too high which of the following could reduce the sample size?
A
 Decrease the expected treatment difference between groups
B
 Increase the power
C
 Increase the variability estimate
D
 Reduce the power

Question Number 10:
If there are complications from elective surgery which was preplanned before a clinical trial starts, which is most true?
A
 The complications should be reported as an AE(s)
B
 It is not an AE
C
 The surgery becomes an AE
D
 It depends on the protocol

Question Number 11:
Which FDA regulation covers Electronic Records?
A
 21 CFR part 11
B
 21 CFR part 50
C
 21CFR part 56
D
 21 CFR part 312

Question Number 12:
E - What does the E in ICH E6 denote?
A
 Efficacy
B
 Environment
C
 Essential
D
 The fifth set of ICH Guidelines

Question Number 13:
S - Which S is a software package used to analyse trial data?
A
 SMS
B
 SIS
C
 SUS
D
 SAS

Question Number 14:
2: What is section 2 of ICH GCP?
A
 Glossary
B
 Sponsor
C
 Principles of ICH GCP
D
 Investigator

Question Number 15:
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 16:
According to ICH what is the definition of "life-threatening" in classifying adverse events?
A
 A condition which could cause death immediately or if it continued to progress.
B
 An event where the subject needed resuscitation.
C
 An event which caused the subject to believe they were going to die.
D
 An event in which the patient was at risk of death at the time of the event; but not one which could have caused death if it had become more severe.

Question Number 17:
Section 6 of ICH GCP states the protocol should generally include stopping rules for individual subjects, parts of trials and entire trial. What other term does it specify in addition to Stopping Rule?
A
 Interim Analyses
B
 Endpoints
C
 Termination Criteria
D
 Discontinuation Criteria

Question Number 18:
What is the numerical answer to the following equation: Sponsor Section of ICH GCP multiplied by the Number of the ICH E Guideline entitled Structure and Content of Clinical Study Reports
A
 9
B
 12
C
 15
D
 18

Question Number 19:

According to ICH GCP which of the following points should a sponsor consider regarding the selection and qualification of auditors?

1) The sponsor should appoint individuals who are independent of the clinical trials/systems to conduct audits

2) The sponsor should ensure that individuals have no conflict of interest issues prior to the audit

3) The sponsor should appoint individuals who have documented GCP Auditing Certification

4) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor's qualifications should be documented

Which of the following answers is correct.
A
 3 only
B
 2 and 3
C
 1 and 4
D
 All of them

Question Number 20:
According to ICH GCP when should the sponsor update the Investigator's Brochure?
A
 Periodically
B
 According to the sponsor's standard operating procedures
C
 As significant new information becomes available
D
 Annually

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