CCRP 無料問題集「SOCRA Certified Clinical Research Professional (CCRP)」

（A）Only after medical monitor approval

（B）Yes, per protocol

（C）Only for a short time, then change to placebo

（D）Only after sponsor and IRB approval

（A）A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

（B）A note that the qualified investigator could be financially compensated by the sponsor to conduct the clinical trial

（C）An explanation of the person to contact at the sponsor for further information regarding research subjects' rights

（D）A statement confirming that the subject has received a copy of the signed consent document

（A）The reviewing IRB/IEC at one of the sites that is planning to enroll subjects has not yet reviewed and approved the study

（B）The FDA issued a clinical hold, and 30 days have elapsed

（C）The sponsor failed to submit an accurate annual report of the study to the FDA

（D）An investigator failed to submit safety reports to the FDA

（A）You might experience adverse events of myalgia, arthralgia, and lethargy

（B）You might have some mild side effects while taking the investigational drug

（C）You might develop symptoms of myalgia, arthralgia, and tiredness

（D）You might have some muscle aches, joint pain, and tiredness

（A）A change in the manufacturing site for the investigational product

（B）A significant change in an investigator's financial interest in the investigational product

（C）The addition of a new test that is intended to improve monitoring the subject for an adverse effect

（D）The addition of a sub-investigator with the scientific training and expertise to conduct the investigation

（A）Pharmacist

（B）FDA

（C）Sponsor

（D）IRB/IEC

（A）Once a year until study close-out

（B）At least weekly

（C）Every 4-6 weeks until study close-out

（D）In a timely manner before, during, and after the study