Single Sites | Quorum Review IRB

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  • Change a Study

    You must notify an IRB/REB of changes in research before implementing them. Many administrative changes do not require re-consenting, but we still need to review and approve them. You may provide rationale for not re-consenting participants, which the board will consider.

    What to Do

    Here are examples of study changes that we expect an investigator 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.

    Contact your account manager with any questions about IRB/REB review of amendments. Otherwise, to get started on your amendment submission, visit the Forms Wizard; select “Single-Site” and then either “Make Changes to a Study Protocol,” or “Make Changes to Site Information.” For purely administrative changes, select “Change a Study’s Contact, Notification, or Shipping Information.”

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    What to Expect

    Our expedited reviewers and 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 case consent form changes are made, we will review the board’s preferences with you before issuing final approvals.

    And What to Check

    Site or Investigator Changes
    Our most common site 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.

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

  • Recruitment and Study Materials

    Quorum must approve any recruitment materials which potential participants will see, and any study-related materials (such as study tools or device instructions) which participants will receive. We review materials for all media, including the Internet.

    What to Do

    Contact your account manager, or get started with our Forms Wizard. Choose “Single-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. For your records we provide an approval notice and copies of the materials as approved.

    And What to Check

    Model Ads in Initial Submission
    If you include advertisements or study materials with your initial protocol submission, we do not charge for their review.

    Ad agencies
    Please alert your account manager if you are authorizing an outside agency to prepare, submit, and revise your advertisements.

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

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

    Translations
    Quorum needs to review and approve the translated, non-English versions of any participant study materials or advertisements before use.

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

  • Safety Reporting

    As the Principal Investigator, you must notify the IRB/REB about certain safety events. 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 “Single-Site” and then “Submit Safety Information” for a list of documents you might need. Use the Safety Information & UP 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 information.

    And What to Check

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

  • Continuing Review

    When the board first approves your research 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 expect to receive your updated information at least six weeks before your IRB/REB approval expires.

    What to Do

    A single site prepares for its continuing review with two forms: the Continuing Review Report for Protocols and the Site Status Report for Periodic Review or Closure. The two forms collect the information the IRB/REB needs to consider renewing its approval.

    We will send you copies of the reports as your approval expiration date approaches. You also can find smart form versions of the forms in the OnQ Portal, or download the forms through the Forms Wizard. For the Forms Wizard, check “Single Site,” then “Submit Continuing Review of Protocol” and “Submit Periodic Review of Site.” You can submit the completed forms through the OnQ portal or email them to your account manager.

    What to Expect

    Your account manager will review your reports 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 board’s approval.

    And What to Check

    Our guidance documents for continuing review reports contain useful advice, in particular about reporting enrollment numbers.

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

  • Closing

    Quorum accepts closing reports as a site completes its 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. (If applicable), the sponsor/CRO has administratively closed the site.

    What to Do

    The site should complete the Site Status Report by following the instructions for closing.

    What to Expect

    Quorum will send you a formal acknowledgement of your closing report.

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

    In case a study closes by mistake, you can request to reopen with our Reopen Request Form for Sites.

Get in touch

Quorum’s user-oriented processes and accredited review boards work support you and your participants throughout a study. Contact us to learn more about our services for investigators; obtain a board roster and meeting schedule; or ask about ethics review pricing.

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