ICH GCP SECTION 4 INVESTIGATOR EXAM ACTUAL QUESTIONS
AND ANSWERS
Investigators should be... - CORRECT ANSWER✅✅Qualified by education, training and experience to
assume responsibility for a trial
Meet all qualifications of regulatory requirements
Provide evidence of those qualifications (4.1.1)
The investigator should be familiar with... - CORRECT ANSWER✅✅appropriate use of IP as described in
protocol, current IB and product information (4.1.2)
The investigator should be aware of and comply with... - CORRECT ANSWER✅✅GCP and other
regulatory requirements (4.1.3)
The investigator/institution should permit... - CORRECT ANSWER✅✅monitoring and auditing by the
sponsor and inspection by appropriate regulatory authorities (4.1.4.)
The investigator should maintain a list of... - CORRECT ANSWER✅✅appropriately qualified persons to
whom the investigator has delegated significant trial-related duties (4.1.5)
The investigator should be able to demonstrate... - CORRECT ANSWER✅✅a potential for recruiting the
required number of suitable subjects within the agreed recruitment period (4.2.1)
The investigator should have sufficient time to... - CORRECT ANSWER✅✅properly conduct and
complete the trial within the agreed trial period (4.2.2)
The investigator should have available an adequate number of... - CORRECT ANSWER✅✅staff and
facilities to conduct the trial safely (4.2.3)
, The investigator should ensure that all persons assisting with the trial are... - CORRECT
ANSWER✅✅adequately informed about the protocol, IP, and trial related duties and functions (4.2.4)
The investigator is responsible for __________ any individual or party to whom they delegate trial-
related duties at the trial site. - CORRECT ANSWER✅✅supervising
If the investigator/institution retains the services of any individual or party to perform trial-related
duties and functions, they should... - CORRECT ANSWER✅✅ensure that these entities are qualified to
do the duties, and implement procedures to ensure the integrity of procedures performed and data
generated (4.2.6)
Who should be responsible for trial-related medical decisions? - CORRECT ANSWER✅✅a qualified
physician who is a PI or Sub-I.
During/following a subject's participation in a trial, the investigator should ensure that
__________________ is provided to a subject for any AE's. - CORRECT ANSWER✅✅adequate medical
care (4.3.2)
Who should the investigator inform about the subject being in the trial (if the subject consents to them
doing so)? - CORRECT ANSWER✅✅The subject's primary physician (4.3.3)
What should the investigator try to get from a subject that withdraws early from a trial (while still
respecting subject rights)? - CORRECT ANSWER✅✅The reason why they withdrew (4.3.4)
What should an investigator have prior to conducting a trial? - CORRECT ANSWER✅✅IRB approval for
protocol, ICFs, subject materials. (4.4.1)
What should an investigator submit to the IRB along with their protocol, ICF, and subject materials? -
CORRECT ANSWER✅✅IB (4.4.2)
During the trial the investigator should provide ________ to the IRB - CORRECT ANSWER✅✅all
documents subject to review (4.4.3)
AND ANSWERS
Investigators should be... - CORRECT ANSWER✅✅Qualified by education, training and experience to
assume responsibility for a trial
Meet all qualifications of regulatory requirements
Provide evidence of those qualifications (4.1.1)
The investigator should be familiar with... - CORRECT ANSWER✅✅appropriate use of IP as described in
protocol, current IB and product information (4.1.2)
The investigator should be aware of and comply with... - CORRECT ANSWER✅✅GCP and other
regulatory requirements (4.1.3)
The investigator/institution should permit... - CORRECT ANSWER✅✅monitoring and auditing by the
sponsor and inspection by appropriate regulatory authorities (4.1.4.)
The investigator should maintain a list of... - CORRECT ANSWER✅✅appropriately qualified persons to
whom the investigator has delegated significant trial-related duties (4.1.5)
The investigator should be able to demonstrate... - CORRECT ANSWER✅✅a potential for recruiting the
required number of suitable subjects within the agreed recruitment period (4.2.1)
The investigator should have sufficient time to... - CORRECT ANSWER✅✅properly conduct and
complete the trial within the agreed trial period (4.2.2)
The investigator should have available an adequate number of... - CORRECT ANSWER✅✅staff and
facilities to conduct the trial safely (4.2.3)
, The investigator should ensure that all persons assisting with the trial are... - CORRECT
ANSWER✅✅adequately informed about the protocol, IP, and trial related duties and functions (4.2.4)
The investigator is responsible for __________ any individual or party to whom they delegate trial-
related duties at the trial site. - CORRECT ANSWER✅✅supervising
If the investigator/institution retains the services of any individual or party to perform trial-related
duties and functions, they should... - CORRECT ANSWER✅✅ensure that these entities are qualified to
do the duties, and implement procedures to ensure the integrity of procedures performed and data
generated (4.2.6)
Who should be responsible for trial-related medical decisions? - CORRECT ANSWER✅✅a qualified
physician who is a PI or Sub-I.
During/following a subject's participation in a trial, the investigator should ensure that
__________________ is provided to a subject for any AE's. - CORRECT ANSWER✅✅adequate medical
care (4.3.2)
Who should the investigator inform about the subject being in the trial (if the subject consents to them
doing so)? - CORRECT ANSWER✅✅The subject's primary physician (4.3.3)
What should the investigator try to get from a subject that withdraws early from a trial (while still
respecting subject rights)? - CORRECT ANSWER✅✅The reason why they withdrew (4.3.4)
What should an investigator have prior to conducting a trial? - CORRECT ANSWER✅✅IRB approval for
protocol, ICFs, subject materials. (4.4.1)
What should an investigator submit to the IRB along with their protocol, ICF, and subject materials? -
CORRECT ANSWER✅✅IB (4.4.2)
During the trial the investigator should provide ________ to the IRB - CORRECT ANSWER✅✅all
documents subject to review (4.4.3)
