Sponsors/CROs Initial Submission Observational Minimal Risk Registries: FAQs
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.
The primary advantage of having a study designated as a Registry is that there are fewer submission requirements for the investigators. The Registry Site Information Questionnaire is significantly shorter than the standard site questionnaire and has been specifically tailored to ask questions pertinent to registry studies. A CV is not required for a registry site submission. Also, there is separate pricing for certain registry studies. Please log on to Quorum’s portal for more information on timelines and to view a registry pricelist.
To qualify as registry, a protocol should not involve any interventions that are greater than minimal risk specifically for the research. To consider a study for registry status, a sponsor must request this evaluation be completed on the initial protocol submission form.
When a principal investigator is submitting to Quorum Review IRB as part of a registry study, s/he must use a different version of the study questionnaire. PIs in a registry study must submit the Observational Registry Site Information Questionnaire. A CV is not required for a registry site submission.
Depending on the site and study, the supplemental materials (e.g., for an additional facility or audit information) may still be required.
Please contact Initial Study Support for an explanation of pricing requirements.
I am interested in transferring jurisdiction of a study from another IRB to Quorum, what should I do?
Quorum has created an efficient process for transferring jurisdiction of IRB oversight. Please contact Initial Study Support at (877) 472-9883 or InitialStudySupport@quorumreview.com if you’d like more information about this process.