Sponsors CROs

Sponsors
and CROs
  • Start a Study

    If you are from a sponsor or a CRO (Contract Research Organization) and are managing a multi-site study, your key document for a protocol submission to Quorum is the Central Study Questionnaire (CSQ). The CSQ collects the information we need to set up your study and ensures we have all the documentation in hand for an IRB/REB review. The CSQ asks a broad range of questions, such as therapeutic area, the phase of the study, how many sites you expect will submit to Quorum, and how you would like us to handle certain tasks (safety reporting, site submissions, translations, advertisements, etc.). 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 CSQ and all of our other forms at the Forms Wizard. Select “Sponsor-CRO,” and then “Initiate a Study for a list of the forms you might need. The Annotated Central Study Questionnaire and the Central Study Submission Checklist provide helpful overviews.

    At a minimum, you will need to include the latest version of the protocol and the model consent form with your submission.

    When you have everything ready, you can send your submission electronically through the OnQ Portal.

    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. When the submission is complete, we’ll assign the study to an account manager (who will remain your primary 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 the IRB/REB will review your protocol within five days of receiving a complete submission (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 to review any consent form changes that we suggest. Once an IRB/REB approval is final, our standard is to post approval documents and consent form templates within a week. We can start reviewing sites as soon as the protocol is approved. See Start a Study – Sites for information about site reviews.

    And What to Check

    OnQ Portal
    If you don’t have an OnQ Portal account, consider signing up before you submit. OnQ access means you can use the 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 in additional information as needed. Contact us if you have any questions about the OnQ Portal.

    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. Check out our early engagement services or contact us to learn more.

    Quick Step
    Quorum offers a set of services designed for large and high-priority studies. These services can shorten your submission and documentation timelines. Contact us to learn more.

    Translations
    If you know or suspect you will need translations of your study documents, Quorum can do those for you. You can tell us how to manage your translations on the Central Study Questionnaire.

    Safety Reporting and Recruitment Materials
    The Central Study Questionnaire includes questions that tell us how we should manage safety reports and advertisements. Check those options carefully, and see the guidance in the Annotated Central Study Questionnaire. Contact us with any questions.

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

    Research in Canada
    If your study includes any sites in Canada, be sure to note that in the Central Study Questionnaire. Our North American Board has authority to approve research in Canada as well as in the United States.

    Other International Research
    Contact us if your research includes any sites outside of the United States or Canada. We can support that research in a number of ways.

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

    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.

    Late-Phase/Minimal Risk
    Our Expeditable Research Review 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 central studies includes the Expedited Review Request for Initial Review of Research; contact us before submitting if you have any questions.

  • 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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