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Weekly GCP Challenge

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Challenge: ICH GCP - What is the difference?

Question Number 1:
In ICH GCP what is the difference in requirements between a non-therapeutic and a therapeutic clinical trial?
A
 A non-therapeutic trial does not require Ethics Committee approval
B
 Oral or proxy consent is not normally allowable for a non-therapeutic trial
C
 Non-therapeutic trials are not ethical and should not be conducted
D
 There is no difference in requirements

Question Number 2:
In ICH GCP what is the difference between Quality Assurance and Quality Control?
A
 Quality assurance is conducted by auditors and quality control is conducted by monitors
B
 There is no difference
C
 Quality control is the operational techniques and activities which are part of quality assurance
D
 Quality assurance is the sponsor's responsibility and quality control is the investigator's responsibility

Question Number 3:
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 4:
In ICH GCP what is the difference between an inspection and an audit
A
 An inspection is conducted by a regulatory authority and an audit is conducted by or on behalf of the sponsor.
B
 An inspection is independent of the clinical trial and an audit is not.
C
 Audits occur during the clinical trial and inspections after the trial has finished.
D
 There is no difference

Question Number 5:
In ICH GCP what is the difference between and Independent Ethics Committee and and Independent Data Monitoring Committee?
A
 There is no difference
B
 The Ethics Committee provides initial Ethical approval for the study and the Data Monitoring Committee provide approval for any changes once the trial is underway
C
 The Ethics Committee provides ethical approval and the Data Monitoring Committee provides regulatory approval
D
 The Ethics Committee provides ethical approval and the Data Monitoring Committee assesses the ongoing progress of the study in order to make recommendations about whether to continue, stop or modify the trial

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