Research Sites | Quorum Review IRB

  • IBC Services

    When your human subject research involves gene transfer, certain types of immunotherapy, or other uses of recombinant or synthetic DNA, you need to ensure research subjects, study staff, and the local environment are not harmed by modified genetic material or any infectious delivery vectors. An institutional biosafety committee (IBC) reviews and oversees research involving recombinant or synthetic DNA and other biohazards.

    Does your study require review by an IBC? If so, we offer integrated IRB and IBC services.

    Contact us now to initiate or ask questions about Quorum IBC services.

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  • Change a study

    Investigators must notify an IRB/REB of changes in research before implementing them. Many administrative changes do not require re-consenting; you may provide rationale for not re-consenting, which the board will consider.

    In the case of a protocol-level change, the sponsor/CRO will manage the changes with the IRB/REB, and we will send each site the notice of any approvals.

    As a site, you need to notify us of certain changes at your location.

    What to Do

    Here are examples of study changes that we expect a site to submit for review:

    • Change in principal investigator
    • Change in site location
    • Protocol changes that alter the risk or benefits of participants in the study
    • Changes in planned enrollment of vulnerable populations, including, but not limited to, employees and family members of employees, illiterates, and non-English speaking participants
    • Intentional departure from the inclusion/exclusion criteria set forth in the protocol when such variation affects the safety or welfare of study participants or affects the study integrity, even if the departure is approved by the sponsor.

    To get started on your amendment submission, visit the Forms Wizard. Select Research Site and Change a Study for the forms you might need. When you’re ready, you can submit your documents via the OnQ Portal.

    What to Expect

    Our expedited reviewers and our boards meet every day to review submitted materials. During the review of a proposed change, our reviewers will confirm whether the amendment requires re-consenting participants.

    In the case of protocol-level changes that the sponsor/CRO submits, Quorum will send you notices of any approvals; copies of any revised consent forms; and guidance (if any) about re-consenting.

    And What to Check

    Site or Investigator Changes
    Our most common site-specific amendments come from changes in contact information, or a change in Principal Investigator. We have a specific process and form for this; please see the Change Request Form for Sites.

    Any new or revised participant study documents (consent forms, instructions, study tools) will need translations.

  • Recruitment and Study Materials

    In a multi-site study, a sponsor or CRO may provide protocol-level recruitment materials for a site to use. If so, when Quorum approves them at the protocol level, we also provide site-specific approvals. This can include ads that will run at a national level and model advertisements that sites can use with their specific contact information. We review advertisements for all media, including the Internet.

    A sponsor or CRO may agree that you as a site can prepare and use your own recruitment materials. If so, you will need to submit your materials to Quorum for review and approval.

    A sponsor may provide other study materials for participants, such as study tools or device instructions, and Quorum will provide any approvals to each site, as appropriate.

    What to Do

    To submit any site-specific recruitment materials, you can get started with our Forms Wizard. Choose “Research Site” and “Submit Ads or Participant Materials,” or go directly to the Participant Materials and Retention Program Submissions Cover Page. You can submit all of your materials through the OnQ Portal.

    What to Expect

    Our expedited reviewers and boards review advertisements every day, and we notify you of decisions within hours. After approvals, we provide a notice and copies of the approved recruitment materials for your records.

    And What to Check

    Sponsor/CRO Approval
    The sponsor or CRO of a study may have instructed us not to review site ads until the sponsor/CRO has approved them. You can check with us or with your sponsor/CRO before submitting to see if this is the case.

    Television and Radio Scripts
    We strongly encourage you to submit scripts for approval before recording or filming any advertisements.

    Final Versions
    Quorum also will need to receive and approve the final recordings of any television, radio, or Internet ads before they are used.

    Quorum will need to review and approve any non-English versions of any ads in addition to the English versions.

    Participant Protection Tips
    See our guide on preparing recruitment materials for suggestions on your advertisements.

  • Safety Reporting

    At the site level, you must notify the IRB/REB about certain safety events. Please see our guidance for information about reportable and non-reportable events.

    Your sponsor or CRO arranged how to manage safety reporting at the start of the study. The sponsor/CRO may have agreed to report all protocol-level safety reports itself; it may have asked one site to report on behalf of everyone; or it may expect you to make all safety reports, even ones from the protocol level. You can check with the sponsor/CRO or with us to see how a particular study is arranged.

    Please see Reporting Unanticipated Problems to Quorum Review IRB and Safety Information and Unanticipated Problems Guidelines for details about our safety reporting standards.

    What to Do

    For safety reports, visit the Form Wizard, select “Research Site” and then “Submit Site Safety Information” for a list of useful documents. Use the Safety Information and Unanticipated Problem Report for your submission, which you can make via the OnQ Portal.

    What to Expect

    Quorum provides formal acknowledgement of all reportable safety events. Our full-time medical reviewers assess all safety reports and unanticipated problems, and you will receive inquiries for any necessary follow-up.

    If the sponsor/CRO is submitting safety information on the behalf of sites, you will receive acknowledgements of those reports either from us or from the sponsor/CRO.

    And What to Check

    What Do I Need to Report?
    For more information about safety reporting, check out our guidance documents and tutorials.

  • Site Continuing Review

    When the board first approves your site to participate in a study, it will set a renewal date for approval. Typically, that approval period is for a year, but it could be shorter. Quorum includes the expiration date on its initial approval notices, and we will send you reminders when the renewal date is approaching. We prefer to receive your updated information at least six weeks before your IRB/REB approval expires.

    What to Do

    A site prepares for its continuing review with the Site Status Report. The form collects the information the IRB/REB needs to consider renewing its approval of your site.

    We will send you a copy of the Site Status Report as a reminder that it is coming due. You also can find it in through the Forms Wizard. For the Site Status Report, other forms, and related guidance go to the Forms Wizard, and then check “Research Site” and “Submit Periodic Review of Site.” You can submit the completed form through the OnQ portal.

    What to Expect

    Client Support will review your report and contact you with any follow-up. Once the report is complete, the IRB/REB will review the renewal request. We will send a formal notice with a new renewal date within days of the IRB/REB approval.

    And What to Check

    Our guidance document for the Site Status Report contains useful advice, in particular about reporting enrollment numbers.

    In case your IRB/REB approval lapses, complete the Reopen Request Form for Sites as soon as possible.

  • Closing

    Quorum accepts closing reports from each site as it exits the study. Quorum has three essential criteria to consider a site closed:

    1. All interventions with participants are done;
    2. The site has no actively enrolled participants; and
    3. The sponsor/CRO has administratively closed the site.

    What to Do

    After a sponsor/CRO closes a site, the site should send in a Site Status Report and follow the instructions for closing.

    What to Expect

    Quorum will respond to each Site Status Report with formal acknowledgement to the sponsor/CRO and to the site. We will use the date the sponsor/CRO closed the site as the date of closure.

    And What to Check

    From an IRB/REB perspective, being “closed to enrollment” does not mean closed to research or to IRB/REB oversight.

    We cannot accept a Site Status Report before the sponsor/CRO has closed the site.

    We will accept information about a study after it closes, but we will not issue any subsequent approvals or amendments.

    In case a site or study closes by mistake, the site can request to reopen with our Reopen Request Form.

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Quorum’s AAHRPP-accredited boards and user-oriented processes uniquely support you and your participants . Contact us to learn about our site-specific services; obtain a board roster; or ask any questions about working with Quorum.

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