Withdrawal of Subjects Flashcards
Withdrawal of subjects from a research study implies that:
a) Activities involving interaction or intervention must cease
b) Accessing identifiable private information about the subject be discontinued
c) Observation or recording of private behavior must be stopped
d) All of the above
d) All of the above
a) Activities involving interaction or intervention must cease
b) Accessing identifiable private information about the subject be discontinued
A subject withdrawing from a primary intervention component may still opt to continue secondary interventions which can include:
a) Activities that involve interventions other than those of the primary student interaction, including radiography and venipuncture
b) Accessing private information including medical, educational or social service agency records
c) Participation in studies required to monitor the long term safety of the subject.
d) All of the above
d) All of the above
a) Activities that involve interventions other than those of the primary student interaction, including radiography and venipuncture
b) Accessing private information including medical, educational or social service agency records
c) Participation in studies required to monitor the long term safety of the subject.
If an investigator terminates a subject’s participation in a clinical trial, according to OHRP guidance the investigator should:
a) Terminate all study activities and make sure that no involvement with the subject is ongoing
b) Include activities which are non-interventional only
c) Consult with their private physician about activities which might continue
d) Ask the subject if participation in secondary interventional components should continue
d) Ask the subject if participation in secondary interventional components should continue
A subject who has withdrawn from a research study requests that all of their data be destroyed. According to OHRP guidance the investigator should:
a) Destroy the data immediately
b) Refuse categorically to destroy the data
c) Refer the matter to the IRB
d) Choose to honor the request after consultation with NIH, FDA and the appropriate regulatory agency.
d) Choose to honor the request after consultation with NIH, FDA and the appropriate regulatory agency.
When a subject withdraws from the research study, the investigator should according to OHRP guidance:
a) Document whether the withdrawal was a decision of the subject or the investigator
b) Document whether the withdrawal applied to both the primary and secondary components of the research
c) Report the matter to the IRB depending on the prevailing institutional policy.
d) All of the above
d) All of the above
a) Document whether the withdrawal was a decision of the subject or the investigator
b) Document whether the withdrawal applied to both the primary and secondary components of the research
c) Report the matter to the IRB depending on the prevailing institutional policy.
According to the FDA when a subject withdraws from a clinical trial:
a) All data should be destroyed related to that individual
b) Only data related to serious adverse events be retained
c) The data be kept only if the IRB recommends it
d) All data collected up to the time of withdrawal must remain in the trial data base in order for the study to be scientifically valid.
d) All data collected up to the time of withdrawal must remain in the trial data base in order for the study to be scientifically valid.
The ability of the investigator to retain and analyze the data of a withdrawn subject even if the data includes identifiable information is permitted in:
a) DHHS regulations, but not the FDA regulations
b) FDA regulations, but not in DHHS regulations
c) Neither FDA nor DHHS regulations
d) Both FDA and DHHS regulations
b) FDA regulations, but not in DHHS regulations
According to HIPAA if the research subject revokes a HIPAA authorization:
a) The revocation has to be in writing
b) The revocation does not affect the use or disclosure of data prior to the revocation
c) Both a and b
d) Neither a nor b
c) Both a and b
According to OHRP guidance the informed consent element that the subject may
“discontinue participation at any time”:
a) Can be stated without any reservations
b) Must be explained with regard to data retention in light of the prevailing FDA, DHHS and HIPAA regulations
c) Will be honored by destroying all data
d) Can be overruled by the investigator even if the subject requests it.
b) Must be explained with regard to data retention in light of the prevailing FDA, DHHS and HIPAA regulations
