It is a criminal offense to have signed the FORM FDA 1572 form if commitments made within the document are ignored. True False 8. True False 9. Maintenance of adequate and accurate case histories for study subjects includes documentation that informed consent was obtained prior to a subject's participation in the study. True False 10.
Professional judgment is required throughout the research process.
True False 11. The only circumstance in which an investigator can deviate from the protocol without prior IRB approval is for safety reasons. True False 12. The investigator has primary responsibility for conducting the study, supervising all personnel, and for protecting the rights, safety, and welfare of research subjects. True False 13.