A hint to get modifications approved faster

When submitting study modifications, please clarify in your submission whether any subjects are currently on study and, if so, if they will be affected by the change. For example, will anybody need to be reconsented, or will any study activities that directly involve the subjects change? If this information is included up front, the IRB won’t have to send you an email or a contingency asking for clarification regarding whether the proposed change affects currently enrolled subjects.