ICH Questions Part 4 Flashcards
Double blind study design entails that the following are unaware of the treatment assignment
a) Subject
b) Investigator
c) Monitor
d) All of the above
Double blind study design entails that the following are unaware of the treatment assignment
d) All of the above
a) Subject
b) Investigator
c) Monitor
*staff who are involved in the treatment or clinical evaluation of the subjects are not aware of the treatment received. This includes anyone determining subject eligibility, evaluating endpoints or assessing compliance with the protocol
In a single blind trial the person unaware of the treatment assignment is
a) The subject
b) The investigator
c) The monitor
d) The data analyst
In a single blind trial the person unaware of the treatment assignment is
a) The subject
The purpose of a double blind design is to ensure
a) Deceive the subject
b) Reduce the bias on the part of the investigator
c) Reduce the bias on the part of the subject
d) Reduce bias on the part of subject and investigator
The purpose of a double blind design is to ensure
d) Reduce bias on the part of subject and investigator
The types of bias on the part of the investigator that are reduced or eliminated by blinding may include
a) Making Changes in the protocol eligibility criteria that may favor the sponsor
b) Data falsification and fabrication
c) Lack of Reporting of protocol deviations and serious adverse events
d) All of the above
The types of bias on the part of the investigator that are reduced or eliminated by blinding may include
d) All of the above
a) Making Changes in the protocol eligibility criteria that may favor the sponsor
b) Data falsification and fabrication
c) Lack of Reporting of protocol deviations and serious adverse events
The bias on part of a subject in a clinical trial would best be represented by
a) Complaints to OHRP regarding the IRB
b) Noncompliance with the visitation schedule
c) Altered behavior which may subvert the objective of the trial
d) Non-authorized variation in the drug dosing schedule.
The bias on part of a subject in a clinical trial would best be represented by
c) Altered behavior which may subvert the objective of the trial
The term CRO stands for
a) Certified research Organization
b) Certified Research Officer
c) Contract Research Official
d) Contract Research Organization
The term CRO stands for
d) Contract Research Organization
Good Clinical Practice represents all of the features below except
a) Is a standard for the design conduct performance of a clinical trial
b) A standard for auditing, recording, monitoring and reporting of a clinical trial
c) Assurance that the data are accurate and credible
e) Assurance that the rights, integrity and confidentiality of trial subjects is protected
f) Represents a mandatory regulatory guidance for clinical trial management
Good Clinical Practice represents all of the features below except
f) Represents a mandatory regulatory guidance for clinical trial management
A Data and Safety Monitoring Board does all of the following except
a) Supports SAE review by the IRB
b) Assesses progress of a clinical trial and critical efficacy endpoints
c) Monitors all aspects of data safety for a clinical trial
d) Recommends to the sponsor whether a trial should be continued, modified or stopped
A Data and Safety Monitoring Board does all of the following except
a) Supports SAE review by the IRB
An inspection of a clinical trial is all of the following except
a) Usually performed by a regulatory authority
b) Consists of a review of documents, facilities, records and any other resources at the site
c) May occur at the site or at the sponsor or CRO location
d) Is usually integrated into the monitoring schedule.
An inspection of a clinical trial is all of the following except
d) Is usually integrated into the monitoring schedule.
An institution (medical) is defined as a site for clinical trials and includes
a) Any public or private entity or agency
b) A medical facility
c) A dental facility
d) All of the above
An institution (medical) is defined as a site for clinical trials and includes
d) All of the above
a) Any public or private entity or agency
b) A medical facility
c) A dental facility
An impartial witness is all of the following except
a) A person who cannot be unfairly influenced
b) Attends the informed consent conference when the subject or LAR cannot read
c) Reads any written information supplied to the subject
d) Is usually certified by the institution
An impartial witness is all of the following except
d) Is usually certified by the institution
A monitor ensures that a clinical trial is being performed as specified in
a) The protocol
b) Standard operating procedures
c) Good Clinical Practice and other regulatory requirements
d) All of the above
A monitor ensures that a clinical trial is being performed as specified in
d) all of the above
a) The protocol
b) Standard operating procedures
c) Good Clinical Practice and other regulatory requirements
A non clinical study is one which is all of the following except
a) Includes all animal studies
b) Any non human study
c) Usually precedes human studies
d) May apply to human studies with high risk and no benefit
A non clinical study is one which is all of the following except
d) May apply to human studies with high risk and no benefit
Under ICH GCP all of the following apply to a legally authorized representative (LAR) except:
a) Is an individual authorized to consent on behalf of a trial subject
b) Juridical or other body authorized under applicable law to consent on behalf of a trial subject
c) Often consents in situations where the trial subject is unable to consent for himself because of physical or mental limitations
d) Is authorized to make financial decisions on behalf of the trial subject if hospitalized.
Under ICH GCP all of the following apply to a legally authorized representative (LAR) except:
d) Is authorized to make financial decisions on behalf of the trial subject if hospitalized.
Under ICH a vulnerable subject may include all of the following except (choose all that apply)
a) Medical pharmacy, dental or nursing students
b) Members of the armed forces
c) Subordinate hospital or laboratory personnel
d) Persons kept in detention
e) Pregnant women
f) Fetuses and neonates
g) Children
h) Unemployed, impoverished or homeless persons
i) Nomads, refugees
j) The elderly
k) Ethnic minority groups
l) Uneducated or illiterate individuals
m) minors
n) people with incurable diseases
Under ICH a vulnerable subject may include all of the following except (choose all that apply)
e) Pregnant women
f) Fetuses and neonates
j) The elderly
l) Uneducated or illiterate individuals
*e,f,j are special populations
