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Expedited Review for Post-marketing Minimal Risk Research

Quorum Review recognizes the growing importance of post-marketing research and other studies that gather drug and safety information while posing minimal risk to participants. To support this type of research, Quorum now offers Qualified Minimal Risk (QMR) review. QMR is a submission process tailored to fit the nature of minimal risk research and bolstered by Quorum's established rapid study start-up infrastructure. Under QMR, site submissions are reviewed within two working days and documents are shipped out within two days of an approval.

Quorum's approach to QMR research:

Quorum provides the following services for QMR research:

• Daily site submissions
• Daily expedited review
• Fewer submission documents at study start-up
• A QMR-specific Site Information Questionnaire, shortened and tailored to the circumstances of minimal risk research
• Adequate staffing and robust processes to support minimal risk studies of any size
• Efficient informed consent review with model language crafted specifically for minimal risk studies
• Training, guidance and support for research-naïve investigators

In addition, Quorum's standard suite of support services - a Study Manager as a single point of contact, the Customer Relations and Site Support teams, in-house translations, secure web portal etc. - combine with QMR to deliver world class performance.

Which studies qualify?

QMR utilizes Quorum's established expedited review process. Federal regulations allow an IRB to review new research proposals by expedited review when that research passes a two-pronged test:
(1) It presents no more than a minimal risk to participants.
(2) It falls within one of nine types of research for which expedited review is authorized (Read the Federal Register guidance).

At the sponsor's request, Quorum's Expedited Reviewers will establish a study's status as QMR during initial review of a protocol submission. Quorum's Customer Relations team can assist with the initial QMR submission process and answer any other questions. Quorum's phone number is (206) 448-4082.

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