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.
What does ICH GCP Section 4.8 say about the factors that the investigator should comply with?
"In obtaining and documenting informed consent, the investigator should comply with the applicable regulatory requirements, and should adhere to GCP and to the ethical principles that.........."
What does ICH GCP state about the investigator or trial staff persuading subjects to take part in a trial?
"Neither the investigator, nor the trial staff, should ................... a subject to participate or to continue to participate in a trial"
What does ICH GCP state about the signing process of the informed consent by the subject or subject's legally acceptable representative?
"The written informed consent must be ............... by the subject or subject's legally acceptable representative"
In emergency situations when prior consent of the subject is not possible and the subject's legally acceptable representative is not available the enrolment of the subject should require measures described in the protocol and/or elsewhere, with documented approval/favourable opinion by the IRB/IEC. What does ICH GCP state about the next stages of consent?
"The subject or subject's legally acceptable representative should be........"
ICH GCP states what information and explanations should be provided to the subject prior to informed consent. Which of the following are included in this list?
1) The approximate number of subjects involved in the trial
2) The subject's responsibilities
3) That the trial involves research
4) The expected duration of the subject's participation in the trial
