Good Clinical practice (ICH)
AEs and SAEs, as defined by the protocol, are:
Only recorded in the case of severe injury or death
Carefully and systematically recorded
A routine part of all studies and should be ignored - ANS - Carefully and systematically
recorded
AEs and SAEs, as defined by the protocol, are:
Only recorded in the case of severe injury or death
Carefully and systematically recorded
A routine part of all studies and should be ignored - ANS - All of the above
Approval from the IEC/IRB is not required for which of the following:
Study management plan
Study protocol
Compensation plans - ANS - Study management plan
As long as you document the entire process, you can unblind a participant at the
request of a site investigator who wants to enter the participant ...
True
False - ANS - False
Clinical studies should be run applying GCP principles because:
Applying the principles means that the investigator does not have to follow the study
protocol
It means that the study will be run to a standard which assures the credibility and
accuracy of the data and reported results
Demonstrating that GCP principles are being followed means the study does not need
to be audited - ANS - It means that the study will be run to a standard which assures
the credibility and accuracy of the data and reported results
, ICH-GCP guidelines are a legal requirement and studies found not following it will be
terminated.
True
False - ANS - False
In accordance with GCP the investigator must ensure which of the following: (Please
select all that apply)
Recruitment of an adequate number of participants
An appropriate amount of time is scheduled to carry out and complete the study
effectively
Appropriate facilities for the duration of the study
All staff receive appropriate training on the study protocol, the investigational product
and their duties - ANS - Recruitment of an adequate number of participants
An appropriate amount of time is scheduled to carry out and complete the study
effectively
Appropriate facilities for the duration of the study
All staff receive appropriate training on the study protocol, the investigational product
and their duties
It is important for investigators in low-and middle-income countries to adopt good clinical
practice guidelines because their studies will conseque...
True
False - ANS - True
Participants in a study with an investigational medicinal product should only contact the
study physician if feeling unwell if their own physician ...
True
False - ANS - False
Suspension or termination of the study by the investigator should be reported to which
of the following groups:
Sponsor
DSMB
IEC/IRB
AEs and SAEs, as defined by the protocol, are:
Only recorded in the case of severe injury or death
Carefully and systematically recorded
A routine part of all studies and should be ignored - ANS - Carefully and systematically
recorded
AEs and SAEs, as defined by the protocol, are:
Only recorded in the case of severe injury or death
Carefully and systematically recorded
A routine part of all studies and should be ignored - ANS - All of the above
Approval from the IEC/IRB is not required for which of the following:
Study management plan
Study protocol
Compensation plans - ANS - Study management plan
As long as you document the entire process, you can unblind a participant at the
request of a site investigator who wants to enter the participant ...
True
False - ANS - False
Clinical studies should be run applying GCP principles because:
Applying the principles means that the investigator does not have to follow the study
protocol
It means that the study will be run to a standard which assures the credibility and
accuracy of the data and reported results
Demonstrating that GCP principles are being followed means the study does not need
to be audited - ANS - It means that the study will be run to a standard which assures
the credibility and accuracy of the data and reported results
, ICH-GCP guidelines are a legal requirement and studies found not following it will be
terminated.
True
False - ANS - False
In accordance with GCP the investigator must ensure which of the following: (Please
select all that apply)
Recruitment of an adequate number of participants
An appropriate amount of time is scheduled to carry out and complete the study
effectively
Appropriate facilities for the duration of the study
All staff receive appropriate training on the study protocol, the investigational product
and their duties - ANS - Recruitment of an adequate number of participants
An appropriate amount of time is scheduled to carry out and complete the study
effectively
Appropriate facilities for the duration of the study
All staff receive appropriate training on the study protocol, the investigational product
and their duties
It is important for investigators in low-and middle-income countries to adopt good clinical
practice guidelines because their studies will conseque...
True
False - ANS - True
Participants in a study with an investigational medicinal product should only contact the
study physician if feeling unwell if their own physician ...
True
False - ANS - False
Suspension or termination of the study by the investigator should be reported to which
of the following groups:
Sponsor
DSMB
IEC/IRB
