SOCRA Exam - Practice Questions with Complete Solutions

A subject has been enrolled on a study and was randomized to the non-treatment arm. The protocol outlines study procedures for all subjects to be performed within one week of enrollment. Which of the following statements about this case is correct? a. This subject does not need to undergo any of the study procedures since the subject is enrolled on the non-treatment arm b. This subject should undergo all study procedures as outlined in the protocol c. This subject only needs to undergo the study procedures that pertain specifically to the subject d. This subject can undergo the study procedures whenever it is convenient - ANSWER-b. This subject should undergo all study procedures as outlined in the protocol Informed consent documents must contain which of the following? a. A description of the scientific background for conducting the investigation b. An explanation of the purpose of the investigation c. Contact information for the sponsor of the investigational drug/device d. A description of the investigator's responsibilities - ANSWER-b. An explanation of the purpose of the investigation With respect to IRB/IEC membership, both the FDA and the ICH require that a. A majority of the members' primary area of interest is in a scientific area b. At least one member holds a Ph.D. degree or equivalent c. At least one member's primary area of interest is in a nonscientific area d. A majority of the members are from or have ties to the institution of record - ANSWER-c. At least one member's primary area of interest is in a nonscientific area Which of the following is the proper way to make a correction to a CRF? a. Completely blacken the incorrect entry and then enter the correct information.