FAQ Categories Initial Submission – Sponsor/CROs

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  1. What are the IRB Reporting Procedures for Emergency Use Investigational Devices?

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    Quorum has procedures in place for review of emergency use of test articles. If a subject is in a life-threatening situation where no standard acceptable treatment is available, and there is not sufficient time to obtain Board approval, please contact our Initial Study Support department. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.  We highly recommend reading this article about  Emergency Use of Investigational Devices, including FDA Notification and IRB requirements.

  2. What are the IRB Submission Requirements for Treatment Use Investigational Devices?

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    For Quorum, a treatment use investigational medical device protocol is either submitted as a central study (if submitted by the sponsor) or as a single site study (if submitted by the investigator). The submission forms will depend on the type of submission.

    Please contact our Initial Study Support department for more information on submission requirements or access to our Regulatory Attorney Team. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

  3. What are the IRB Submission Requirements for Compassionate Use Investigational Devices?

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    For Quorum, a proposed compassionate use of an Investigational Device should be submitted as a single site study. We will need the following documents:

    The protocol should include the information that was previously included in the Investigational Device Exemption (IDE) supplement, specifically:

    1. A description of the patient’s condition and the circumstances necessitating treatment;
    2. A discussion of why alternatives therapies are unsatisfactory and why the probable risk of using the investigational device is no greater than the probable risk from the disease or condition;
    3. An identification of any deviations in the approved clinical protocol that may be needed in order to treat the patient; and
    4. The patient protection measures listed above that will be followed.
    5. A monitoring schedule, which should include the investigational nature of the device and the specific needs of the patient. The patient should be monitored to detect any possible problems arising from the device.

    For Quorum’s purposes, the submitted consent form may be based off of the consent form for the approved clinical trial.

    Please contact our Initial Study Support department for more information on submission requirements or access to our Regulatory Attorney Team. They can be reached by phone at (206) 448-4082 or by email at InitialStudySupport@quorumreview.com.

     

  4. What is the difference between compensation and reimbursement?

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    “Compensation” refers to payment for participation in a research study.  “Reimbursement” includes reimbursement for parking and travel, the provision of gifts for participant retention purposes, or the provision of medical devices to be retained by the participant following the study, etc.”

    For more information see the Quorum Review IRB Handbook (requires an OnQ Portal account).

  5. How is safety information acknowledged for a single site study?

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    Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

  6. What are single sites expected to submit to Quorum?

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    At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the Protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. A complete list of the items needed for a single site submission is available on the Single Site Studies page. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions.

  7. What differences can I expect when submitting as a single study?

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    If the single site option is chosen:

    • Information will only be released to the site.
    • The site is responsible for safety reporting (please see more information on this below).
    • The sponsor is not able to submit on behalf of all sites in a multiple single site study.
    • It is more costly to submit multiple single sites under the same protocol then to submit the study as a central study.
  8. How does Quorum define a single site vs. a central study?

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    Quorum defines a study as single site or central based upon with whom we communicate.

    Single site: Quorum communicates directly with the site only. In this case, Quorum is not the central IRB for the study but the site has chosen Quorum as their IRB.

    Central: Quorum communicates with the sponsor/CRO, protocol level decisions are made by the sponsor/CRO on behalf of site(s). In this case, Quorum is the designated central IRB for the study.

  9. Does Quorum review research that will be conducted at Canadian sites

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    Yes. Quorum’s North American Board is an institutional review board/research ethics board that meets on Wednesdays and is authorized to review research involving Canadian sites. Some Canadian sites may qualify for a daily review of sites; other site and protocol reviews will be scheduled for the North American meeting. Read more about our North American review.

  10. Does Quorum review research in Canada?

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    Yes. Quorum Review IRB maintains an ethics review board (referred to as the “North American” Board) and serves as a duly convened research ethics board (REB) and central institutional review board (IRB). The North American Board complies with applicable regulatory requirements and meets every Wednesday and Friday to review U.S. and Canadian studies. Quorum is AAHRPP-accredited and accepts both privately and publicly funded research in Canada. Read more about our North American review here, or contact us for more information.

  11. What submission documents are required by Quorum?

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    Quorum requires the following documents:

    • “Site Information Questionnaire: Primary Research Facility” form
    • Principal investigator’s Curriculum Vitae including clinical research experience with human subjects and education (if applicable,the principal investigator needs to submit a CV to Quorum only once)
    • Medical License
      • Quorum Review IRB verifies the PI’s medical license for all locations where he/she will be conducting research under Quorum Review’s jurisdiction.
      • If the PI is conducting research in a location which does not provide online license verification (e.g. Puerto Rico, certain Canadian provinces, etc.), submission of the PI’s medical license(s) is required.
      • If you do not know if online license verification is available for the location(s) applicable to the PI’s medical license(s), it is recommended to include a copy of the PI’s medical license(s) with the PI’s site submission.
      • If Quorum Review is unable to verify the PI’s medical license(s), processing of the PI’s site submission will be delayed.
  12. How is safety information acknowledged for a Principal Investigator Generated Study?

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    Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

  13. Will Quorum review my study if I am listed on the IND?

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    Quorum generally will not review research where a Sponsor-Investigator is also the sole sponsor of the IND, but may make exceptions on a case-by-case basis. For example, the Board may make an exception in instances where there are additional local protections for subjects that would be recruited for this type of research. The most common exception is where the Sponsor-investigators are still under the jurisdiction of an organization that provides the added protection of organizational policies and procedures, including the management of conflicts of interest, reporting of unanticipated problems and serious or continuing non-compliance, and reporting of scientific misconduct. Additionally, an exception may be made for this type of research if there is an Agreement between the organization and Quorum which requires Quorum to report certain events and actions to the organization. Such an agreements is further evidence that the organization has jurisdiction over of the Sponsor-investigator. Any restrictions imposed based on the forgoing however shall not apply to treatment INDs submitted by Principal Investigators.

  14. Does Quorum have any recommendations regarding the protocol or consent form?

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    It is recommended that you review the Quorum Handbook for information on Board expectations for protocols to be considered for review. This information is available in Appendix A. Also, Quorum has developed a sample consent form which investigators are encouraged to use for guidance in developing consent forms. Quorum also has developed sample genetics consent forms and age appropriate consent forms. These can be provided upon request.

  15. Are there any extra steps during the submission process for Principal Investigator Generated Studies?

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    All Investigator Generated Studies submitted to Quorum Review IRB require pre-review by the Quorum Medical and Legal-Regulatory Consultants. During pre-review, the Consultants may request revisions or additional information before the submission can be scheduled for full Board review. This can extend the submission timelines considerably.

  16. What are investigators expected to submit to Quorum for Principal Investigator Generated Studies?

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    At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. For Investigator Generated studies there are additional requirements, please contact Initial Study Support for details.

    Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), the site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator Brochures). Sites are also expected to promptly submit any Amendments, and consent form revisions.

  17. What is Investigator Generated research?

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    Quorum Review IRB accepts Investigator Generated Studies. Generally, in these types of studies, the principal investigator is acting as both the sponsor and the investigator (a “sponsor-investigator” under FDA regulations). This means that the principal investigator initiates and conducts the research. In addition to Quorum’s standard site submission forms, for Investigator Generated studies the Principal Investigator is responsible for submitting all study-level information for review as well.

  18. Do you require 1572’s?

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    No, Quorum does not review or acknowledge the FDA Form 1572. Quorum’s SIQ collects all the information that Quorum needs from the 1572.

  19. How is safety information acknowledged for a single site Study?

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    Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

  20. What are single sites expected to submit to Quorum?

    Comments Off on What are single sites expected to submit to Quorum?

    At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the Protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. A complete list of the items needed for a single site submission is available on the first page of the single site Study Questionnaire.

    Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions.

  21. What are the consequences of submitting as a single site study?

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    If the single site option is chosen:

    • Information will only be released to the site.
    • The site is responsible for safety reporting (please see more information on this below).
    • The sponsor is not able to submit on behalf of all sites in a multiple single site study.
    • It is more costly to submit multiple single sites under the same protocol then to submit the study as a central study.
  22. How is safety information acknowledged for a single site study?

    Comments Off on How is safety information acknowledged for a single site study?

    Quorum will issue an acknowledgement letter to the site when a revised Investigator Brochure is received. When all other safety information is received, such as Protocol Deviations, IND safety reports, Serious Adverse Event reports, and reports of Unanticipated Problems, Quorum will issue a standard acknowledgment. In the case of a standard acknowledgement, Quorum will stamp the first page of the document with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

  23. What are single sites expected to submit to Quorum?

    Comments Off on What are single sites expected to submit to Quorum?

    At Initial Review, in addition to all site-specific submission materials (Site Information Questionnaire, current CV, and other attachments as applicable) the site is also expected to submit all materials needed for the review of the Protocol including the Protocol, Consent Form, Investigator Brochures and Package Inserts, and any data collection tools. A complete list of the items needed for a single site submission is available on the first page of the Single Site Study Questionnaire. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions. Throughout the life of the study, in addition to reporting research site events (such as Protocol Deviations, Serious Adverse Events, and Unanticipated Problems), a single site is also expected to submit study-level safety information (such as IND safety reports and updated Investigator brochures). Single sites are also expected to promptly submit any Amendments, and consent form revisions.

  24. What are the consequences of submitting as a single site study?

    Comments Off on What are the consequences of submitting as a single site study?

    If the single site option is chosen:

    • Information will only be released to the site.
    • The site is responsible for safety reporting (please see more information on this below).
    • The sponsor is not able to submit on behalf of all sites in a multiple single site study.
    • It is more costly to submit multiple single sites under the same protocol then to submit the study as a central study.
  25. Why do I have to track changes I want into the consent form (for negotiations)/how do I do this?

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    Quorum asks that you track any requested changes into the clean, current version of the consent form and that you submit these changes along with the rationale for the changes. This allows the Board to see what changes have been requested to the current approved version of the consent form. Please turn on the “track changes” feature in Microsoft Word, and submit the consent form revisions electronically.

  26. Is there a way for me to check on the status of the sites that have submitted for the study?

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    Yes. Log in to Quorum’s OnQ Portal, and click on “Reports.” Then, you can generate a site submission status report for any of the Protocols to which you have access. You will be able to see the status of the site (approved, in progress, not yet active) and whether any information is still needed for the site’s submission to be complete.

  27. Who should I submit documents to (amendments, safety information, etc.)?

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    All documents for a study may be submitted via the OnQ Portal. Or, after your initial study submission any protocol-level information may be submitted to your assigned Study Manager via email. Quorum accepts this information via mail as well.

  28. How do I get people signed on and removed from the portal?

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    The primary contact for a study, as designated on the Central Study Questionnaire, is automatically granted portal access for the study. If the primary contact would like to request to have additional users added or removed there are many ways to accomplish this. Prior to submitting your study the last page of the CSQ allows you to list additional users. Additionally, the primary contact can request additional users via email to their Study Manager or Quorum’s Initial Study Support team. It is also possible to request additional users through the Quorum web portal.

  29. How does the OnQ Portal work?

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    The Quorum Review IRB OnQ Portal is password-protected and available to study contacts at the site and sponsor level. Please contact Quorum Review IRB to learn more about this service or to request a portal account. Users can view, download, and print all Quorum Review IRB approval documents and most other Board correspondence. The OnQ Portal also offers a status report for tracking site submissions from initial review through the Board’s final decision. Users can submit materials for review electronically and securely through the OnQ Portal provided that the submission is not larger than 30 MB. For items that are larger than 30 MB either use a compression utility such as WinZip or e-mail items that are less than 50 MB to InitialStudySupport@QuorumReview.com. Alternatively you can mail or fax to the attention of Initial Study Support.

  30. Can you meet my tight deadline/how can I make sure you meet that tight deadline for study startup?

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    Quorum works with sponsors to make sure that studies are started as quickly as possible. However, Quorum cannot issue final approval documents to the sites until they have been approved and the consent form has been finalized. If the timeline is tight it is especially important to respond to your Study Manager with any feedback on the consent form as quickly as possible so that the consent form may be finalized in a timely manner. Once the protocol has been reviewed sites may be scheduled for review while the Board and sponsor negotiate the consent form language. This helps minimize delays. Another item to note, complete site submissions must be received one week prior to a Board meeting to ensure review at or before that meeting; therefore, it would be best that your target site(s) submit as soon as possible.

  31. What happens if the Board makes changes to my protocol or consent form?

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    If the Board has requested consent form revisions, you will be asked to review them and submit additional changes as appropriate. Once the consent forms are finalized and any follow-up issues are resolved, your Study Manager will provide you with a Letter of Approval.

  32. What happens after my study is assigned a Board Review date?

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    Once a complete set of submission elements is submitted for review, Quorum will assign a Study Manager to your study and schedule a review date. Following the Board review, your Study Manager will contact you with the outcome, including any consent form revisions or further information that the Board has requested.

  33. Who is my Study Manager and what is their job?

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    Your Study Manager will be your key point of contact for protocol-related issues. The Study Manager will attend Board meetings where your study will be discussed and will communicate determinations back to you.

  34. What is the schedule of Board Meetings and what are the submission deadlines?

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    Quorum Review IRB has four Boards and conducts up to fourteen convened Board meetings a week. New U.S. protocols can be submitted to three of these meetings (to Board I (Tuesday and Friday) or Board II (Wednesday)). To be scheduled to a meeting for review, a submission must be received (with all required elements) by 5:00 p.m. Pacific Time one (1) week prior to the meeting. U.S. amendments can be submitted to one of the daily meetings (Board III) and must be submitted by 5:00 p.m. PT 36 hours prior. Canadian research must be submitted (with all required elements) to the Wednesday meeting (Board II) by 5:00 p.m. PT the prior Wednesday.