Single Sites | Quorum Review IRB

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    We consider your research a single-site study if you are an investigator working directly with Quorum on a protocol level as well as on a site level, whether that protocol is yours or a sponsor’s. Your key document for an initial submission is the Single Site Study Questionnaire (The SSSQ). Quorum will oversee your site’s research directly, on protocol as well as on site issues, and the SSSQ ensures that we collect the information and the documents we need to get started.

    The SSSQ asks a broad range of questions, such as therapeutic area, the phase of the study, the size and location of your site, your consenting practices, whether any conflicts of interest exist at the site, and whether the protocol is investigator-generated (See And What to Check, below). The more we know from the start, the better prepared we will be for your study’s particular needs.

    What to Do

    You can find the SSSQ and its related forms at the Forms Wizard. Select “Single-Site” and “Initiate a Study and a Site” for a list of forms you might need. The Initial Protocol Submission for Single Site Study Checklist has helpful guidance.

    When you have everything ready, you can send your submission electronically through our secure OnQ Portal. And you always can contact our initial submission team with questions.

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    What to Expect

    Once we receive your submission, our initial submission team will review it and within a day contact you with any follow-up questions. Once the submission is complete, we’ll assign the study to a single site account manager (who will be your primary point of contact throughout the study), schedule the study for the next available IRB/REB meeting, and send the consent forms to our consent form editors.

    We review protocols every day of the week, and we will review your protocol within five days of receiving a complete submission (Although we can review qualifying minimal risk studies much more quickly). During those five days, your account manager may contact you about any issues; this can include follow-up questions from our IRB/REB members, operational teams, regulatory attorneys, or consent form editors.

    Within a few hours of the IRB/REB meeting, your account manager will let you know of the results and provide any follow-up information. You then will have a chance to respond to any questions and review any consent form changes that we suggest. Once an IRB/REB approval is final, our standard is to post approval documents and consent forms within a week.

    And What to Check

    OnQ Portal
    If you don’t have an OnQ Portal account, consider signing up before you submit. OnQ makes submitting and communicating easy. OnQ access means you can use our Smart Form CSQ, an interactive tool which will double-check your responses and help make sure your submission is complete. Once your study gets going, the OnQ Portal provides a convenient area to access approval documents, check status reports, and send us additional information as needed. Contact Us if you have any questions about the OnQ Portal.

    Investigator-Generated Studies
    Investigator-generated studies have some additional considerations before review. Your study may be investigator-generated if you are the author of the protocol; if you have initiated the research yourself; or if you are assuming all regulatory responsibilities for the research. If any of these are the case, we will perform a Chair pre-review of the submitted protocol. Revisions may be requested to the submitted research before Board review can be scheduled. We also may require an Indemnification Agreement as well as proof of liability insurance. Contact us if you have any questions.

    Early Engagement
    If you have questions about your protocol or your consent forms before you submit, we can provide you feedback about either one or both. Contact us to learn more about our early engagement and pre-review services.

    If you know or suspect you will need translations of your study documents, you can let us know up front on the SSSQ, or at any time during the study through your account manager.

    Canadian Research
    If your site is in Canada, it will operate under the jurisdiction of our North American Board, a duly convened REB for overseeing research in Canada.

    Device Study
    For a device study you will need to provide some additional information to help the IRB/REB make its device determinations. The Form Wizard document list includes the Device Study Submission Form; be sure to include that along with SSSQ. Let us know if you have any questions about the review of your device.

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

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    Combination Products
    If your protocol involves a drug or biologic as well as a device, you may have a combination product. The IRB/REB review of combination products is not always straightforward; feel free to ask us about it.

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    Late-Phase/Minimal Risk
    Our Qualifying Expeditable Research program can route the review of some types of low-risk research (such as observational studies or retrospective chart reviews) to our expedited reviewers instead of a full IRB/REB review. The Form Wizard document list for single-site studies includes the Expedited Review Request for Initial Review of Research and the Questionnaire for Single-Site Research-Retrospective Chart Reviewcontact us before submitting if you have any questions.

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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.

    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.

    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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