Sponsors and CROs | Quorum Review IRB

Sponsors
and CROs

Faster study activation. Exceptional service. Quorum accelerates your research with the largest offering of complimentary study support services and award-winning site support. We are the only IRB that provides custom guidance and a personalized, client-friendly approach. To get started, choose from the options below or contact us.

  • Get a Quote

    As part of our continued effort to help clients achieve reduced fulfillment time, Quorum Review IRB offers a complimentary quote request feature to help you quickly and accurately budget for your next study.

    Try out this new, no-obligation feature today: Get a Quick Quote

    After submitting your trial details, we will contact you by the next business day or sooner with a quote.

  • 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.

  • Request OnQ Portal Account

    Request an OnQ Portal Account
    Request Account

  • Change a Study

    In most cases, Sponsors or CROs must notify an IRB/REB of any changes in research before implementing them. Many administrative changes do not require re-consenting, but we still need to review and approve the changes. You may provide a justification for not re-consenting participants, which the reviewers will consider.

    What to Do

    Here are examples of study changes that we would expect a sponsor or CRO to submit to an IRB/REB:

    • 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 “Sponsor/CRO” and “Make Changes to a Study Protocol.” The primary form to use is the Amendment Submission Cover Page.

     

    What to Expect

    Our expedited reviewers and our boards meet every day to review submitted materials. During the review, 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. After the approvals are final, we will deliver to your sites the amendment approvals and any consent form changes.

    And What to Check

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

    Affected Sites
    Let us know as soon as possible whether the amendment affects all sites in the study equally, and whether we need to prepare different approval documents or consent forms for any subsets of sites.

  • Recruitment and Study Materials

    A sponsor/CRO can submit to Quorum any protocol-level recruiting materials. This can include ads that will run at a national level, or model advertisements for sites to use locally. We review advertisements for all media, including the Internet.

    This process is essentially the same for advertisements as for other study materials — such as study tools or device instructions — that participants will receive.

    What to Do

    Contact your account manager, or get started with our Forms Wizard. Choose “Sponsor/CRO” and “Submit Ads or Participant Materials” for a list of forms, or you can 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 approved copies of the recruitment materials for your records. We also can send approvals to all sites which will use the materials.

    And What to Check

    Model Ads and Study Materials in Initial Submission
    If you include advertisements or study materials with your initial protocol submission, we do not charge for the review and the approval notice goes out to every site automatically.

    Site-Specific Ads
    At the start of the study, we will ask you whether sites may use their own advertisements and, if so, whether you want to see and approve the ads before we review them.

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

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

    Final Versions
    Quorum needs to receive and approve the final recorded versions of any television, radio, or Internet ads.

    Translations
    Quorum will need to review and approve any non-English versions of materials that the study will use.

    Participant Protection Tips
    See our guides on preparing recruitment and study materials.

  • Safety Reporting

    Sponsors and CROs can report protocol-level safety events to the IRB/REB. These can include unanticipated problems, updates to safety information, and other events. Please see Reporting Unanticipated Problems to Quorum Review IRB and Safety Information and Unanticipated Problems Guidelines for details.

    What to Do

    To submit any safety reports, visit the Form Wizard, select Sponsor-CRO and then Submit Protocol Safety Information for a list of useful documents. Use the Safety Information and Unanticipated Problem Report for your submission, which you can do via the OnQ Portal.

     

    What to Expect

    Quorum provides formal acknowledgement of all reportable safety reports. Our full-time medical reviewers assess all safety reports and unanticipated problems, and you will receive inquiries for any necessary follow-up information. We also will send acknowledgements to all active sites in the study, if you have asked us to do so (usually at the start of the study).

    And What to Check

    Who Reports, the Sponsor or the Sites?
    When you first start your study, we ask you to set up reporting authorities. You as the sponsor/CRO can submit protocol-level reports on behalf of all sites. You also can require sites to report on their own, or designate one site to report on behalf of everyone in the study.

    What Should We Report?
    For more information about safety reporting and the IRB/REB, check out our guidance documents and tutorials.

  • Continuing Review

    When the board first reviews your research, it will set a renewal date for approval. Typically, that period is annually, 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 the Continuing Review Report at least six weeks before the renewal date.

    What to Do

    A sponsor/CRO prepares for a protocol’s continuing review with the Continuing Review Report for Protocols. The form collects the information the IRB/REB needs to renew its approval of the research.

    You can find the form on our Forms Wizard, and your account manager will forward it to you as an early reminder. You can submit the completed form through the OnQ portal or email it to your account manager.

    What to Expect

    Your account manager will review your report and contact you for 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. Quorum’s site teams will send renewal notices to each of your sites as the anniversary date of its IRB/REB review date approaches.

    And What to Check

    Our guidance document for the Continuing Review Report contains useful advice, in particular about reporting enrollment numbers. And your account manager is always available.

    Your sites will go through a similar process for renewal, and their prompt responses can ensure no one’s IRB/REB approval lapses from a late report. If IRB/REB approval for a site does lapse inadvertently, the site should submit the Reopen Request Form immediately.

  • Closing

    Reports for closing a study typically come from the site level. Quorum accepts closing reports from each site as it exits the study; once all of the sites have closed, Quorum will acknowledge the study’s closure at the protocol level.

    Quorum has three essential criteria to consider an investigative site closed:

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

    What to Do

    After all participants have completed the study and a sponsor/CRO closes a site, the site should send in a Site Status Report for Closing.

    What to Expect

    Quorum will send a formal acknowledgement of each Site Status Report to the site and to the sponsor/CRO. The date of administrative closure by the sponsor/CRO will be the date of closure on the acknowledgement.

    Once we have closed all of the sites in the study, we will send a protocol-level acknowledgement of closure to the sponsor/CRO.

    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 not 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.

Get in touch

Quorum’s AAHRPP-accredited boards and user-oriented processes uniquely support multi-site studies. Contact us to learn more about our services for sponsor and CROs; obtain a board roster and meeting schedule; or request ethics review pricing.

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