If the SMART IRB Standard Operating Procedures (SOPs) are used, the Lead Study Team (or designee) is responsible for submitting amendments to the Reviewing IRB in accordance with the Reviewing IRB’s policies. This applies to study-wide and local amendments.
If a Relying Institution requires a local amendment, that study team is responsible for alerting the Lead Study Team (or designee) and providing them with sufficient details to prepare the submission for the Reviewing IRB. In the case of personnel changes and updates to study team member conflicts of interest, the study team must also report these changes to their local Point of Contact (POC). For personnel changes, the Relying Institution’s POC assures the Reviewing IRB that the study team member has completed required training, is qualified to participate in the study, and has adequate resources to conduct the study. In the case of updates to or identification of new potential conflicts of interest, the local POC determines whether there are additional actions required by the Relying Institution or whether this information affects the decision to cede review of the study to the Reviewing IRB.