Determining Review Requirements

Review requirements depend on the level of review a protocol initially received. To identify your protocol’s level of review—Exempt, Expedited, or Full Board—refer to the information in the most recently issued approval or determination letter for your study. Review the amendment criteria below based on the level of review and nature of the change.

Upon review of the proposed changes, RCS and the IRB may determine an alternative path of review is necessary to satisfy regulatory requirements and to protect the rights and welfare of participants.