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Weekly GCP Challenge

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Challenge: ICH GCP 25 Question Test

Question Number 1:
According to ICH GCP what are the absolute minimum requirements for essential documents at site before IMP can be sent to the site.
A
 CV of investigator and Clinical Trial Authorisation (CTA)
B
 Ethics Committee Approval and signed protocol
C
 CTA and Ethics Committee Approval
D
 CTA, Ethics Committee Approval and signed protocol

Question Number 2:
What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify (legal and financial XXXXX) the investigator against claims arising from the trial, except for claims arising from malpractice and/or negligence?
A
 Compensation
B
 Coverage
C
 Costs
D
 Compliance

Question Number 3:
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 4:
What does ICH GCP state about how to preserve the independence and value of an audit?
A
 Audits should be performed by individuals independent of the sponsor organisation
B
 Audit reports should not be made available to trial personnel
C
 Regulatory authorities should not routinely request the audit reports
D
 Audits should be performed by more than one individual

Question Number 5:
Which of the following is not in the list given by ICH GCP for the factors guiding the audit plan and procedures for a trial audit?
A
 importance of the trial to submissions to regulatory authorities
B
 number of subjects in the trial
C
 type and complexity of the trial
D
 duration of treatment for each trial subject

Question Number 6:
According to ICH GCP when should a sponsor provide an audit certificate?
A
 Always
B
 Whenever an audit has been completed successfully
C
 When requested
D
 When required by applicable law or regulation

Question Number 7:
According to ICH GCP chapter 8 where should ORIGINAL completed CRF pages be filed?
A
 In the sponsor files
B
 In the site file
C
 Either the sponsor file or the site file is OK as long as it is stated in the protocol
D
 It doesn't specify

Question Number 8:
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 9:
What is the word missing from the following statement regarding the content of the statistics section of a protocol in ICH GCP Section 6. Procedure for accounting for missing, unused and XXXXXX data.
A
 non-validated
B
 subjective
C
 spurious
D
 outlying

Question Number 10:

ICH GCP states that a Sponsor Audit is independent and separate from which of the following?

1) Routine Monitoring

2) Regulatory Inspection

3) Quality Control Functions

4) Site Close Out Visit

Which of the following is correct?
A
 1 only
B
 1 and 3 only
C
 2 and 3 only
D
 Al of them

Question Number 11:
In ICH guidance on content of informed consent which words are missing from the following: "The trial procedures to be followed, including .........."
A
 the number of visits
B
 all invasive procedures
C
 all non-routine procedures
D
 the number and type of samples to be obtained

Question Number 12:

What comes next. What should an IRB/IEC should safeguard for all trial subjects?

  • Rights
  • Safety
  • ......

 
A
 Confidentiality
B
 Well-being
C
 Protection
D
 Treatment

Question Number 13:

According to ICH GCP what always resides with the sponsor?

 
A
 Ultimate responsibility for the trial
B
 Ultimate responsibility for subject safety
C
 Ultimate responsibility for the quality and integrity of the trial data
D
 Ultimate responsibility for meeting the applicable local regulatory requirements

Question Number 14:
According to ICH which of the following observations require expedited reporting to Regulatory Authorities?
A
 An increased rate of occurrence of an "expected"serious ADR
B
 A significant hazard to the patient population such as lack of efficacy
C
 A major safety finding from a newly completed animal study
D
 All of the above

Question Number 15:

According to ICH GCP when can an investigator implement a deviation from, or change to a protocol without agreement of the sponsor and prior approval/favourable opinion of the IRB/IEC?

1) Never

2) To eliminate an immediate hazard to trial subjects

3) When the change involves only logistical or administrative aspects

4) When advised by the Monitor
A
 1 only
B
 2 and 4 only
C
 3 and 4 only
D
 2 and 3 only

Question Number 16:
What word is missing from this ICHGCP definition of an Adverse Event: Any medical occurance in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
A
 direct
B
 investigational
C
 untoward
D
 No word is missing

Question Number 17:
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 18:
According to ICH GCP what should the sponsor do before entering into an agreement with the investigator/institution?
A
 Provide a protocol and an up to date Investigators Brochure
B
 Check the investigator's qualifications
C
 Perform a visit to assess the site
D
 All of the above

Question Number 19:
According to ICH GCP the information for clinical trial subjects should include: "That the subject or the subject's legally acceptable representative will XXXXX"
A
 be required to sign the consent form
B
 have a responsibility to inform the investigator of any change of circumstances affecting the subject's ability to participate in the trial
C
 be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial
D
 be required to maintain confidentiality regarding the trial and the subject's participation in the trial

Question Number 20:
According to ICH GCP which section of the protocol should contain "Procedures for eliciting reports of and for recoding and reporting adverse event and intercurrent illnesses"?
A
 Trial Objectives and Purpose
B
 Trial Design
C
 Treatment of Subjects
D
 Assessment of Safety

Question Number 21:

According to ICH GCP if the answer to the question is "Monitoring" what could the question be?

a) Which process is used to verify that the rights and well-being of human subjects are protected

b) Which process is used to verify that the reported trial data are accurate, complete, and verifiable from source documents

c) Which independent process is used to determine whether trial related activities were conducted to the protocol, the SOPs, GCP and the applicable regulatory requirements
A
 a or b only
B
 b or c only
C
 a, b or c
D
 a only

Question Number 22:
What are the IEC quorum requirements according to the ICH GCP?
A
 Quorum should be as stipulated by the local regulations.
B
 Quorum should be as stipulated by the SOPs of the EC.
C
 Five members constitute the quorum
D
 Depending on the protocol, any of the above.

Question Number 23:
According to ICH GCP the extent and nature of what should be determined based on considerations such as objective, purpose, design, complexity, blinding, size and endpoints of the trial?
A
 Auditing
B
 Monitoring
C
 Source Data Verification
D
 Quality Control

Question Number 24:

According to the Multicentre Trials section of ICH GCP when should supplemental CRFs be provided?
A
 For investigators who are collecting additional data
B
 For country/region specific requirements
C
 To collect screening data to ensure consistency across all trial sites
D
 To allow for additional recruitment at specific sites

Question Number 25:

Which of the following ICH Guidelines includes the following guidance:

"An add-on study is a placebo-controlled trial of a new agent conducted in people also receiving standard treatment. Such studies are particularly important when available treatment is known to decrease mortality or irreversible morbidity, and when a non-inferiority trial with standard treatment as the active control cannot be carried out or would be difficult to interpret. It is common to study anticancer, antiepileptic, and heart failure drugs this way."
A
 ICH E6 - GCP
B
 ICH E8 - General Consideration of Clinical Trials
C
 ICH E9 - Statistical Principles in Clinical Trials
D
 ICH E10 - Choice of Control Groups

Question Number 26:

According to ICH GCP which of the following statements are true about record retention?

  1. The sponsor should inform the investigator in writing of the need for record retention
  2. The sponsor should notify the investigator in writing when the trial related records are no longer needed
  3. It is the responsibility of the investigator to notify the IRB/IEC when the trial related records are no longer needed
A
 1 only
B
 1 and 2 only
C
 All of them
D
 None of them

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