FAQ Categories Initial Submission

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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. I have two facilities, one that is administrative and one that sees patients. Which location should I use for which form?

    Comments Off on I have two facilities, one that is administrative and one that sees patients. Which location should I use for which form?

    The location where patients are being seen and research is being conducted should be listed as the primary research facility on the SIQ. The administrative facility can be listed as the contact address. There is no need to fill out an additional form for administrative facilities.

  11. How do I know if my CV is already on file with Quorum?

    Comments Off on How do I know if my CV is already on file with Quorum?

    If you aren’t certain if your site has submitted to Quorum before you can contact Client Support, the protocol Study Manager or the Initial Study Support team.

  12. Does Quorum require a CV for each sub investigator?

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    From time to time, Quorum’s Board will request submission of sub investigator’s CVs. Your sponsor probably will notify you if this request is made. Less frequently, the Board might ask for additional information about your site.

  13. What type of information is required on an investigator’s CV?

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    The CV must describe the principal investigator’s education, licensure (for all states in which the research is being conducted), training, clinical background, and research experience relevant to the study in question. If the principal investigator’s relevant research experience is not included in the CV, please provide additional documentation as necessary.

  14. What are the most common errors Quorum sees on site submissions?

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    The most common item area of confusion on the Site Information Questionnaire is the question on participant compensation. Please ensure that the per visit amount multiplied by the number of visits equals the total amount you have provided. Also, please ensure that you provide information on whether your site is planning to compensate participants for any substudies, if there are any.

    Additional delays are caused when sites fail to completely and accurately respond to all questions on the SIQ. The best way to prevent this error is to address ALL questions and if you feel the question doesn’t pertain to your site write in “N/A” rather than leaving it blank.

    To ensure that your submission is complete and able to be processed immediately upon receipt by Quorum, please reference the SIQ workbook on the forms tab. If you have any questions regarding your submission, please contact the Client Support Team.

  15. How do I know if I need to submit additional documents in addition to the SIQ?

    Comments Off on How do I know if I need to submit additional documents in addition to the SIQ?

    The SIQ instructions will alert you if any of the following elements are needed.

    • “Site Information Questionnaire: Additional Research Facility” form
    • Proposed site-specific advertisements and recruitment materials. These materials should be accompanied by written sponsor approval if this is required by the sponsor
    • Proposed site-specific participant study materials (diaries, questionnaires, written study instructions, etc.)
    • Supplemental material as appropriate based on “Site Information Questionnaire” responses (for example, FDA Audit information, letters of explanation, etc.)
  16. 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.
  17. 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.

  18. I developed a protocol and received funding to conduct it from an outside source. Is the outside source considered the sponsor of the research?

    Comments Off on I developed a protocol and received funding to conduct it from an outside source. Is the outside source considered the sponsor of the research?

    The mere provision of funds to a principal investigator to conduct research does not make the outside source the sponsor of the research. A “sponsor” has specific responsibilities concerning the research being conducted.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. Can I still use the regular SIQ?

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    You CANNOT submit using the standard SIQ if the study has been qualified as observational registry. Utilization of the standard SIQ will cause your site to be held from review until the complete Observational Registry SIQ is received.

  25. What is required for an observational registry site submission?

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    A CV is not required for an observational registry site submission. Depending on the answers to the questions on the Observational Registry SIQ, supplemental materials (e.g., for an additional facility or audit information) may still be required.

  26. 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.

  27. 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.

  28. 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.

  29. 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.
  30. How does Quorum define a single site vs. a central study?

    Comments Off on How does Quorum define a single site vs. a central study?

    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.
  31. 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.

  32. 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.

  33. 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.
  34. How does Quorum define a single site vs. a central study?

    Comments Off on How does Quorum define a single site vs. a central study?

    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.