An investigator has received IRB approval for a clinical trial. During the course of the study, the investigator decides to make some changes to the study procedures to make management of the study easier for him and his study team. The investigator must do the following: Proceed with the changes. The study team is overwhelmed by this study and its complicated procedures. Proceed with the changes. The investigator has determined that these changes are minor and do not add any risk to the subjects. Proceed with the changes. The investigator has determined that these changes are warranted and therefore may enact them Contact the IRB office to determine the appropriate course of review. Once IRB approval is obtained, the investigator may proceed with the changes.
