Protocol Deviations Flashcards
A protocol deviation is?
a) Any departure from the procedures and practices described in an IRB approved protocol
b) Any action associated with regulatory non-compliance
c) Failure to follow the appropriate procedure or protocol for the informed consent process
d) All of the above.
d) All of the above.
a) Any departure from the procedures and practices described in an IRB approved protocol
b) Any action associated with regulatory non-compliance
c) Failure to follow the appropriate procedure or protocol for the informed consent process
A pharmacist providing an investigational drug for a Phase I protocol makes an error in the dosing which is not associated with any adverse event in the subject. The event is?
a) A protocol deviation
b) An unanticipated event of risk to self or others
c) Both a and b
d) Neither because it is not a serious adverse event
c) Both a and b
A subject in an IND protocol misses a study visit because of a work related engagement and shows up for the scheduled visit two days after the due date. There are no medical consequences. The event is?
a) A protocol deviation
b) A serious adverse event
c) An unanticipated event of risk to self or others
d) Regulatory non-compliance
a) A protocol deviation
One of the most common protocol deviations is?
a) Missed or late study visit because of patient non-compliance
b) Missed or late study visit because of mistakes in scheduling of the Pl
c) Drug dose related miscalculations
d) Failure to maintain a delegation of authority log for the clinical trial.
a) Missed or late study visit because of patient non-compliance
A high risk protocol deviation would be one with?
a) High risk to patient
b) High risk to the study
c) Both a and b
d) High risk to the institution
c) Both a and b
During a study monitoring visit, the monitor observes the following documents are incomplete or missing: the investigator’s CV, the delegation of authority log, IRB approval letters. This should be?
a) Reported as a protocol deviation
b) Part of study monitoring, immediately remediable and not reportable to the IRB
c) Reportable as an adverse event to the sponsor
d) An unanticipated event reportable by the IRB to OHRP.
b) Part of study monitoring, immediately remediable and not reportable to the IRB
In a study under an IND involving an oral drug the subject misses two doses and takes an extra-large dose on the third day to make up for the missed doses. She suffers a serious medical event which needs hospitalization. The event is?
a) A protocol deviation only
b) A serious adverse event only
c) A protocol deviation that is also a serious adverse event
d) Not reportable because this is a patient error and not an investigator error.
c) A protocol deviation that is also a serious adverse event
In a study under an IND, an investigator enrolls a patient without informed consent which is done after the patient’s first visit. Later the informed consent undergoes a change which requires re-consent. The investigator fails to obtain re-consent. The event is?
a) A protocol deviation
b) Serious or continuing non-compliance
c) Both a and b
d) Not reportable because such an event is not described in the DHHS regulations
c) Both a and b
During a study monitoring visit the study monitor observes several errors in the case report forms and a failure to attach source documents in support of the data recorded. The event should be?
a) Reported as a protocol deviation
b) Part of study monitoring, immediately remediable and not reportable to the IRB
c) Reportable as an adverse event to the sponsor
d) An unanticipated event reportable by the IRB to OHRP.
b) Part of study monitoring, immediately remediable and not reportable to the IRB
Late reporting of a protocol deviation?
a) Is itself a protocol deviation
b) Is a serious adverse event
c) Is of no consequence because DHHS regulations do not specify a time period for reporting protocol deviations
d) Is an event of interest only to the sponsor
a) Is itself a protocol deviation
During a study monitoring visit, the study monitor observes that the revised versions of the Investigator’s brochure are not being kept in the regulatory binder for the study. The sponsor asks the investigator to report this as a protocol deviation to the IRB. The investigator should?
a) Not report it because it is not within institutional guidelines for a protocol deviation
b) Not reportable because it was corrected by the investigator
c) Not reportable because it is a minor event of no risk to patient or study
d) Follow the sponsor’s instructions and report it to the IRB.
d) Follow the sponsor’s instructions and report it to the IRB.
During the study monitoring visit, it was noted that the sample for laboratory analysis were being shipped long after the required shipment date. Many of the samples were deemed non-evaluable. The event is?
a) a Protocol deviation
b) a Serious adverse event
c) An unanticipated event of risk to self or others
d) Nor reportable because the lab measurements were not of central importance to the study outcome.
a) a Protocol deviation
Laboratory related protocol deviations can include?
a) Improper lab sample collection
b) Improper shipment of a lab sample which results in a non-evaluable sample.
c) Improper storage of the sample prior to shipment
d) Shipment of the sample by non-certified personnel
e) Any of the above.
e) Any of the above
a) Improper lab sample collection
b) Improper shipment of a lab sample which results in a non-evaluable sample.
c) Improper storage of the sample prior to shipment
d) Shipment of the sample by non-certified personnel
During a study under an IND the investigator places the data on a laptop and the laptop is stolen. The data was not encrypted. The event is?
a) a Protocol deviation
b) Unanticipated event of risk to self or others
c) Both a and b
d) Serious adverse event
c) Both a and b
A protocol deviation should be?
a) Reported to the IRB on forms designated for such reports
b) Reported directly to OHRP by the investigator
c) Reported to the FDA
d) Not reportable as this is not addressed in DHHS regulations.
a) Reported to the IRB on forms designated for such reports
A protocol deviation should be reported to the IRB?
a) Promptly
b) Within the prescribed institutional guidelines
c) Both a and b may apply
d) According to the investigator’s convenience as the time period is not specified in DHHS regulations.
c) Both a and b may apply
When a protocol deviation is observed on several occasions the investigator should?
a) Batch the reporting of the protocol deviations for reporting to the IRB
b) Report it directly to institutional officials
c) Report it to the IRB only after it has been corrected
d) Develop a comprehensive Corrective and Preventive Action Plan (CAPA plan)
d) Develop a comprehensive Corrective and Preventive Action Plan (CAPA plan)
The essential elements of a Corrective and Preventive Action Plan (CAPA plan) developed in response to repeat protocol deviations might include?
a) Root cause analysis
b) Training and education needs to ensure repeat events do not occur
c) System changes to ensure future prevention
d) All of the above.
d) All of the above
a) Root cause analysis
b) Training and education needs to ensure repeat events do not occur
c) System changes to ensure future prevention
Protocol deviations are reportable to the FDA:
a) If the event is associated with a serious adverse event
b) Routinely
c) Only if the OHRP recommends it
d) Never
a) If the event is associated with a serious adverse event
