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.
In which of the following ICH Guidelines would you find the following guidance?
"The groups should not only be similar at baseline, but should be treated and observed similarly during the trial, except for receiving the test and control drug."
Which of the following ICH Guidelines contains the following guidance?
"Preliminary studies of activity or potential therapeutic benefit may be conducted in Phase I as a secondary objective."
Which of the ICH Guidelines contains the following guidance?
"The scientific integrity of the trial and the credibility of the data from the trial depend substantially on the trial design."
Which of the following ICH Guidelines includes the following guidance?
"The use of a placebo control group does not imply that the control group is untreated. In many placebo-controlled trials, the new treatment and placebo are each added to a common standard therapy"
Which of the ICH Guidelines includes the following guidance:
"Clinical trials should be scientifically sound, and described in a clear, detailed protocol."
Which of the following ICH Guidelines includes the following guidance:
"An add-on study is a placebo-controlled trial of a new agent conducted in people also receiving standard treatment. Such studies are particularly important when available treatment is known to decrease mortality or irreversible morbidity, and when a non-inferiority trial with standard treatment as the active control cannot be carried out or would be difficult to interpret. It is common to study anticancer, antiepileptic, and heart failure drugs this way."
