What are the requirements for a study to be considered an Observational or Minimal Risk Registry Study (Registry)?

Observational registries are limited to data collection and do not include any procedures or interventions conducted specifically for the research (including randomization or assignment to treatment groups). Minimal risk registries involve only minimal risk interventions (for more information on minimal risk procedures, please refer to the Quorum Handbook). In order for Quorum to review a study under the “Registry” designation, a protocol should not involve any interventions that are greater than minimal risk specifically for the research.