If an IRB has already approved any informed consent documents for the applicable clinical trial prior, then the trial will be considered “initiated” before the compliance date, and the new statement will not be required. For example, if an IRB approved consent documents for a particular site for a multi-site trial, but documents for another site have not been approved by that date, then all documents for the entire applicable clinical trial will be exempt from including the statement and do not need to be in compliance with the provision. If an IRB has not
approved any informed consent documents for the applicable clinical trial , then all informed consent documents associated with the applicable clinical trial must in compliance with the requirement and include the new statement. If the multi-site applicable clinical trial includes multiple IRBs or the multi-site applicable clinical trial is under one IRB, the effect is still the same. The sponsor of the trial is responsible for determining the applicable clinical trial initiation date.