Pharmaschool.co ICH GCP Quiz with 100% complete answers
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Pharmaschool.co ICH GCP Q
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Pharmaschool.co ICH GCP Q
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 Authorization (CTA)
b. Ethics Committee Approval and signed protocol
c. CTA and Ethics Committee Approval
d. CTA, Ethics...
Pharmaschool.co ICH GCP Quiz
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 Authorization (CTA)
b. Ethics Committee Approval and signed protocol
c. CTA and Ethics Committee Approval
d. CTA, Ethics Committee Approval and signed protocol correct answersc. CTA and Ethics Committee Approval
What C is missing from this statment in ICH GCP: The sponsor should provide insurance or should indemnify (legal and financial ____________) the investigator against claims arising from the trial, except
for claims arising from malpractice and/or negligence? section 5.8.1
a. Compensation
b. Coverage
c. Costs
d. Compliance correct answersb. Coverage
Complete this statement from ICH GCP: neither the investigator, nor the trial staff, should _________ 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 correct answersb. Coerce
What does ICH GCP state about how to preserve the independence and value of an audit? section 5.19.3d a. Audits should be performed by individuals independent of the sponsor organization
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 correct answersc. Regulatory authorities should not routinely request the audit reports
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? section 5.19.3b 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 correct answersd. Duration of treatment for each trial subject
According to ICH GCP when should a sponsor provide an audit certificate? 5.19.3e a. Always
b. Whenever an audit has been completed successfully
c. When requested
d. When required by applicable law or regulation correct answersd. When required by applicable law or regulation
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 correct answersa. In the sponsor files 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? section 6.4.6
a. Interim Analyses
b. Endpoints
c. Termination Criteria
d. Discontinuation Criteria correct answersd. Discontinuation Criteria
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 ___________ data. section 6.9.5
a. non-validated
b. subjective
c. spurious
d. outlying correct answersc. Spurious
ICH GCP states that a Sponsor Audit is independent and separate from which of the following? section 5.19.1
a. Routine Monitoring
b. Regulatory Inspection
c. Quality Control Functions
d. Site Close Out Visit correct answersa. & c. (Routine monitoring & Quality Control functions)
In ICH guidance on content of informed consent which words are missing from the following: "The trial procedures to be followed, including .........." section 4.8.10d
a. the number of visits
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