Answer the questions below and then click the button. The next page will mark your answers and show you how well you have done compared with the previous people who have taken the tests.
According to ICH GCP the Investigator or person designated by the investigator should do what when there is any deviation from the approved protocol?
1) Document it
2) Not make any deviation
3) Explain it
4) Ensure the deviation is handled consistently
According to ICH GCP when can an investigator implement a deviation from, or change to a protocol without agreement of the sponsor and prior approval/favourable opinion of the IRB/IEC?
1) Never
2) To eliminate an immediate hazard to trial subjects
3) When the change involves only logistical or administrative aspects
4) When advised by the Monitor
The investigator may implement a deviation from, or a change of, the protocol to eliminate an immediate hazard without prior IRB/IEC approval/favourable opinion. As soon as possible what should be submitted to the IRB/IEC, the Sponsor and if applicable the Regulatory Authority(ies)?
1) the implemented deviation
2) the reasons for the deviation
3) if appropriate the proposed protocol amendment
According to ICH GCP which of the following would be adequate for an investigator/institution and the sponsor to sign to confirm agreement of the investigator to conduct the trial in compliance with the protocol?
1) Protocol
2) Alternative Contract
3) Investigator Brochure
4) Initiation Visit Report
According to ICH GCP where would you routinely find a description of "Actions taken or to be taken and/or actions recommended to secure compliance"?
