Observational & Minimal Risk Registries

Study Start-Up Process

Welcome to the Quorum study Independent IRB start-up process. We are committed to working with you to make the submission process as straightforward as possible.

Quorum Review IRB offers a simplified process for observational and minimal risk registries. 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).

Studies that are determined by Quorum Review to be an observational or minimal risk registry type study have shorter forms and fewer submission requirements. Registry studies with 50 sites or more also enjoy discounted fees.

It is important to note that the registry designation is granted AFTER Quorum Review makes an internal assessment and confirms that the study qualifies to use the simplified observational/minimal risk registry process.

A sponsor should request this evaluation be completed on the initial protocol submission form.

Standard protocol submission requirements:

  • Study protocol
  • All proposed consent forms (in electronic Microsoft Word format)
  • Investigator’s brochures, package inserts, or device background literature for all primary and comparator drugs/devices
  • Central Study Questionnaire
  • Device Study Submission form (as applicable)
  • Proposed study-wide advertisements and recruitment materials
  • Proposed study-wide participant study materials (diaries, questionnaires, written study instructions, etc.)
  • Any e-Consent certificates (as applicable)

After Quorum Review has reviewed the protocol and consent form, the registry status determination will be communicated to you by the Initial Study Support department.

If the study is qualified, principal investigators will be required to submit a simplified version of the site questionnaire, which is significantly shorter than the standard site questionnaire and has been specifically tailored to ask questions pertinent to registry studies.

Depending on the site and study, the supplemental materials (e.g., for an additional facility or audit information) may still be required.

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