Which of the following is an example of a study modification that does not require IRB approval once the study has been initiated?
A) Enrolling four additional subjects as participants because some initial participants dropped out in the middle of the study
B) An impromptu change in the statistical analysis due to the development of a new software program
C) A change in the delivery method of a medication to eliminate an immediate hazard to study subjects
D) A change in the recruitment posters for the study
Correct Answer:
Verified
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