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  1. How do I comply with the New Jersey Access to Medical Research Act?

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    The New Jersey Access to Medical Research Act [N.J. Rev. Stat. § 26:14-1 to 26:14-5] sets forth requirements for medical research involving persons who lack cognitive capacity. These requirements complement, and in some cases go beyond, the federal regulation standards for using legally authorized representatives to obtain informed consent.

    Quorum Review facilitates compliance with the Access to Medical Research Act, when applicable, by providing investigative sites in New Jersey consent forms that meet all of the Act’s requirements, including, but not limited to, a signature line for an otherwise uninvolved person to attest that the Act’s requirements for consent have been met [N.J. Rev. Stat. § 26:14-4c].

    New Jersey investigators are responsible for fulfilling all other requirements of the Access to Medical Research Act. Among other things, this includes having an attending physician with no connection to the proposed research assess the potential subject’s capacity; identifying an appropriate authorized representative(s) to act according to the subject’s known health care instructions and to provide surrogate consent, if appropriate; and ensuring the subject has not otherwise objected to the assessment of capacity or the proposed research.

    Please refer to the New Jersey Access to Medical Research Act for more information.

     

  2. 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.

  3. 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.

  4. 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.

     

  5. 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).

  6. 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.

  7. 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.

  8. 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.
  9. 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.

  10. Will I receive acknowledgement that Quorum has received my report?

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    Acknowledgement will come in the form of your Notice of Re-Approval documents or closing acknowledgment letter. If you wish to verify sooner whether or not we have received your Site Status Report, you can contact our Client Support Team at (206) 448-4082.

  11. What will delay my review?

    Comments Off on What will delay my review?

    An incomplete or inaccurate form, any missing attachment(s), (e.g. FDA audit documentation, letter(s) of explanation, SAEs, PDs, UPs) and/or missing/blank page(s).

  12. What supporting documentation should I submit in addition to this form?

    Comments Off on What supporting documentation should I submit in addition to this form?

    Any FDA audit documentation, letters of explanation as required by the form, and any additional information that you think will help Quorum with the review of your site. Please refer to the Periodic Site Review Checklist/Instruction Sheet for further guidance.

  13. Can you hold my Site Status Report if I think I am going to close prior to expiration?

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    No. Once Quorum receives a Site Status Report, a process of analysis and scheduling for the board is started. It is left to your discretion if you wish to hold your report at your site until your scheduled closeout visit to avoid going through Periodic Site Review. Please see the previous question and answer (above) for ramifications of this choice.

  14. What do I do with my Site Status Report if I think I am going to close before my expiration?

    Comments Off on What do I do with my Site Status Report if I think I am going to close before my expiration?

    Quorum requires that all sites submit a valid Site Status Report 45 calendar days prior to expiration. Failure to do so will result in overdue notifications. It is left to your discretion if you wish to hold your Site Status Report at your site until your scheduled closeout visit to avoid going through Periodic Site Review.

    If you choose to do so, please bear in mind the following:

    • Closing visits are often cancelled or rescheduled. It is a good idea to prepare for Periodic Site Review in case this happens by completing your report and notifying Quorum of the situation.
    • If we do not receive the report by the due date, we must adhere to our notification procedures that include a fax and expiration warning letter that is copied to your sponsor. Even if you contact us to let us know that you are planning on closing, you will still receive our overdue notifications as part of our due diligence to assure that no sites expire.
    • If the report is not received within 14 calendar days of the expiration date, your site will be scheduled for IRB review. Upon review, the IRB may consider your failure to comply with the requirement to submit a Site Status Report as an instance of noncompliance. Please note that findings of noncompliance are reported to the sponsor and the FDA.
  15. What form do I submit to Quorum for change of information such as study coordinator change, change in participant compensation, etc?

    Comments Off on What form do I submit to Quorum for change of information such as study coordinator change, change in participant compensation, etc?

    If you have changed any of the information covered by question 26 and it has not yet been reported to Quorum, then you must submit a completed Change Request Form for Sites) and any accompanying documents noted on the form.

    Writing your changes on the Site Status Report or attaching a brief letter of explanation is not acceptable, and these changes will not be made unless submitted to Quorum on a completed Change Request Form for Sites.

  16. Do I need to cite an updated version of the consent if our site is done enrolling and no participants have signed it?

    Comments Off on Do I need to cite an updated version of the consent if our site is done enrolling and no participants have signed it?

    Yes. Please indicate on question 23 the most current English main/core study approved consent form received from Quorum by your site. Please answer questions 24A and 24B indicating that no participants have signed the updated version and state the reason why. If participants have signed a previous version of the consent form for this study, please answer question 24C.

  17. Do I need to send in a hard copy of the consent form(s)?

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    No, listing the version and date of the current consent form on the Site Status Report is sufficient. Quorum can verify this internally for discrepancies.

  18. Do I need to include old versions of the consent form(s)?

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    No. You only need to list the most current English main/core versions of the consent form. You do not need to list translated versions of the consent form or addenda.

  19. What if no participants have been enrolled in this study? How do I complete the Information and Consent Form section?

    Comments Off on What if no participants have been enrolled in this study? How do I complete the Information and Consent Form section?

    If no participants have been enrolled at your site for this study, indicate in question 23 the most current English main/core Quorum-approved study consent form you have received for this study from Quorum and complete Question 24A and 24B stating that no participants have been enrolled in this study.

  20. How do I know which dates to write for the consent form(s)?

    Comments Off on How do I know which dates to write for the consent form(s)?

    Please use the version and date listed in the footer (often on the left hand side) of the main consent form (e.g. “Version 1, dated 01/01/00”). Do NOT use the “Quorum Approved” date, which is often stamped on the lower right-hand side of the consent form. 

    The “Version Date” is the date the consent form was originally reviewed by Quorum for use in the study. 

    The “Quorum Approved” date is the date that Quorum-approved your site to use the consent form.

  21. What consent form(s) should I list on the Site Status Report form?

    Comments Off on What consent form(s) should I list on the Site Status Report form?

    You should list the most current English main/core Quorum-approved study consent form received by your site from Quorum (question 23). Please do not list consent forms such as Translated, Addendum, Assent, Pharmacogenetic or Pharmacokinetic consent forms.

  22. My site/principal investigator/sub investigator was recently audited but hasn’t received any documentation from the FDA yet. What do I include with my Site Status Report?

    Comments Off on My site/principal investigator/sub investigator was recently audited but hasn’t received any documentation from the FDA yet. What do I include with my Site Status Report?

    Please include a memo stating that no results from the audit have yet been received and include any notifications for audit or correspondence with the FDA leading up to the audit with your Site Status Report. Once you have received the audit results, please submit them to Quorum for review.

  23. I’ve received a good practices letter from the FDA. Do I need to submit this?

    Comments Off on I’ve received a good practices letter from the FDA. Do I need to submit this?

    Yes, if you have not previously submitted this letter to Quorum for consideration in this study. Quorum requires all documentation of FDA audits of the principal investigator, sub investigators, and research facilities to be submitted.

  24. Do I need to submit Adverse Events, Minor Protocol Deviations or Minor Unanticipated Problems to Quorum Review?

    Comments Off on Do I need to submit Adverse Events, Minor Protocol Deviations or Minor Unanticipated Problems to Quorum Review?

    Usually not. Quorum requires sites to submit an analysis of Adverse Events, Minor Protocol Deviations and other Minor Unanticipated Problems that have not been reported to Quorum Review only if in combination they adversely affect the risk/benefit ratio of the study; the rights, safety, or welfare of the participants or others; or the integrity of the study. Quorum does not review individual event reports or line listings of Minor Deviations, Adverse Events, or Minor Unanticipated Problems.

  25. How do I know if I need to submit my Major Protocol Deviations/Violations or Serious Adverse Events to Quorum?

    Comments Off on How do I know if I need to submit my Major Protocol Deviations/Violations or Serious Adverse Events to Quorum?

    Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information about Major Protocol Deviations/Violations and SAE reporting requirements. If you have not submitted Major Protocol Deviations/Violations or Serious Adverse Events to Quorum for a particular study, please do so immediately. If you are uncertain if you have already reported them, or if we have received them, please contact Quorum to verify their receipt.

  26. If I have Major Protocol Deviations/Violations or Serious Adverse Events for my study that have not been submitted to Quorum, should I send them now with my Site Status Report?

    Comments Off on If I have Major Protocol Deviations/Violations or Serious Adverse Events for my study that have not been submitted to Quorum, should I send them now with my Site Status Report?

    Yes. Any major Protocol Deviations/Violations or Serious Adverse Events not yet reported to Quorum must be submitted with the Site Status Report for Periodic Site Review or Closing.

  27. How does Quorum define an Unanticipated Problem (UP)?

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    Quorum defines an Unanticipated Problem as any problem that adversely affects – the risk/benefit ratio of the study; – the rights, safety, or welfare of the participants or others; or – the integrity of the study. Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information.

  28. How does Quorum define a Serious Adverse Event (SAE)?

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    Quorum defines a Serious Adverse Event as any event that is serious, unanticipated, and related to the study product/procedures. Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information.

  29. How does Quorum define a Major Protocol Deviation/Violation (PD)?

    Comments Off on How does Quorum define a Major Protocol Deviation/Violation (PD)?

    Quorum defines a Major Protocol Deviation/Violation as any intentional or unintentional change from the IRB-approved protocol that adversely affects the risk/benefit ratio of the study; the rights, safety, or welfare of the participants or others; or the integrity of the study. Please refer to the Safety Information and Unanticipated Problems Reporting Guidelines for more information.

  30. What if my site has used a translated consent form not approved by Quorum? What if my site has used a translated consent form not approved by Quorum?

    Comments Off on What if my site has used a translated consent form not approved by Quorum? What if my site has used a translated consent form not approved by Quorum?

    Please submit the translated consent form that was used, a letter of explanation, and a completed major protocol deviation/violation form to Quorum with your Site Status Report. 

    In your letter of explanation, please indicate if you wish to receive a Quorum-approved translated consent form for future use and provide a plan for corrective action to prevent this from occurring in the future. You must indicate what language you want the consent to be translated into and who at your site is fluent in that language.

  31. What if my site has used an advertisement that was not approved by Quorum?

    Comments Off on What if my site has used an advertisement that was not approved by Quorum?

    Please submit the advertisement that was used, a letter of explanation, and a completed Protocol Deviation (Major)/Violation Report form to Quorum with your Site Status Report.

    In your letter of explanation, please indicate whether or not you would like Quorum to review the advertisement and give approval for its future use and provide a plan for corrective action to prevent this from occurring in the future.

  32. How should I account for a participant that transferred from/to another site?

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    Sometimes participants transfer to other sites because they move or because a site may stop doing the study. If a participant transfers away from your site to another site, they should be counted as a participant who dropped or withdrew early. 

    If a participant transferred to your site from another site, please include this participant in the question asking for the total number of participants who signed a consent form throughout the course of this study. (see question 3 in Section Two).

  33. How should I account for participants that died during the study?

    Comments Off on How should I account for participants that died during the study?

    Since death is considered an adverse event, such participants should be listed in question 5. To determine if the death is an SAE (Serious Adverse Event) and reportable to Quorum, please refer to the Safety Information and Unanticipated Problems Reporting Guidelines Form.

  34. What is the difference between a screen failure and a participant who withdrew early?

    Comments Off on What is the difference between a screen failure and a participant who withdrew early?

    Generally, a screen failure is someone who does not get enrolled into the study for various reasons, documented during the screening process. Screen failures signed the consent form and may have had screening procedures but did not undergo any other study procedure. Reasons for the participant to fail screening may include, but are not limited to, the participant not meeting inclusion criteria or meeting exclusion criteria (ineligibility). Your sponsor or protocol may define a screen failure differently.

    A “participant who withdrew” is a participant who either:

    1)  stopped the study before completing the full schedule of study visits (including follow-up),
    – OR –
    2) who transferred sites.

    Some protocols may have a variable number of visits and consider participants as completing, rather than withdrawing, in the case of disease progression or similar clinical outcome. In such cases, the protocol definition should be followed, with the withdrawal category reserved for participants who withdrew for other reasons.

  35. What should I indicate as my site’s status at periodic site review?

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    Not Yet Initiated:
    Your site has not yet been initiated for this study by the sponsor, but you still plan to participate in the study.

    Active:
    Your site is currently actively participating in the study and enrollment is still open.

    Active – enrollment is closed:
    This study is still open at your site, but you are closed to enrollment.

  36. What is the difference between being closed and closed to enrollment?

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    Closed: You have no active enrolled participants, you are no longer collecting data from participants and your sponsor or the sponsor’s representative considers you closed. 

    Closed to Enrollment: Your site is no longer enrolling new participants into the study. However, you may still have active participants in the study and/or other study activity may still be taking place. Please DO NOT submit a Site Status Report indicating your site is closed when your study is just closed for enrollment. Doing so could result in Quorum Review closing your file prematurely and may require a new site submission.

  37. What if my site is scheduled to close before the IRB expiration date?

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    If you are closed, or planning to close before your IRB expiration date, you should complete a Site Status Report for closure and submit it to Quorum. If you don’t expect to close until after your expiration date, you should remain open and submit a Site Status Report for periodic site review. If the sponsor or sponsor representative will be closing your site a couple of days prior or on your expiration date, Quorum suggests you send in a Site Status Report for Periodic Site Review to prevent site expiration.

    Please note that if a Site Status Report is not received by the IRB approval expiration date, IRB approval to conduct your study will expire. Be advised that conducting research activities without IRB approval is a violation of federal regulations. Furthermore, failure to provide a Site Status Report may lead to a finding of serious or continuing noncompliance which requires notification to the U.S. Food and Drug Administration.

  38. When does Quorum consider a site to be closed?

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    Quorum considers a site to be closed when all of the following criteria have been satisfied:

    • You have no enrolled participants.
    • You are no longer collecting data from participants.
    • Your sponsor or the sponsor’s representative considers you closed.

    If your site does not meet all of these requirements, Quorum does not consider you closed. If you do not meet these requirements but your sponsor does consider you closed, please contact Quorum for further guidance on this matter.

  39. What is Periodic Site Review?

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    Periodic Site Review is a review that occurs prior to your study expiration date. If you plan to continue to conduct your study after your expiration date listed on your Notice of Approval (or Notice of Re-Approval), then you will need to submit a Site Status Report for periodic site review.

  40. Does Quorum have a separate form for sites in Observational Registry or Qualified Minimal Risk studies?

    Comments Off on Does Quorum have a separate form for sites in Observational Registry or Qualified Minimal Risk studies?

    Yes. Quorum has a form called the Observational Registry or Qualified Minimal Risk Site Status Report used for periodic site review or closure. This form is available on Quorum’s website. Quorum will also send a copy of the Observational Registry and Qualified Minimal Risk Site Status Report prior to the site’s anniversary.

  41. We made modifications to my previously approved material, do I need to submit for review again?

    Comments Off on We made modifications to my previously approved material, do I need to submit for review again?

    Yes, changes to previously approved recruitment or participant study materials should be submitted to Quorum Review IRB for approval prior to implementing the change.

    Spelling corrections and changes to site specific contact information as indicated with space holders are allowed without additional approval from Quorum Review. If no space holders are present, the advertisement should not be modified. If no space holders are present, the advertisement should not be modified.

  42. Does a posting on ClinTrials.gov need review?

    Comments Off on Does a posting on ClinTrials.gov need review?

    According to recruitment guidelines, internet listings where the system format limits the information provided to basic trial information, such as the title; purpose of the study; protocol summary; basic eligibility criteria; study site location(s); and how to contact the site for further information do not require review.

    If you are unsure if something requires review or not, you can send a copy of the material to your Study Manager and ask to have a Recruitment Specialist analyze the listing to determine if your item requires review prior to use. If it is determined that the item does not require IRB review, our Recruitment Specialist will then send you a fax documenting the material does not require IRB review.

  43. I would like my materials translated, what should I do?

    Comments Off on I would like my materials translated, what should I do?

    Quorum offers translation services in over 100 languages and dialects for all study related documents, including recruitment and study materials. Please contact your Study Manager if you would like more information regarding these services.

  44. What is Generic Material Review?

    Comments Off on What is Generic Material Review?

    An investigator or sponsor/CRO/SMO may submit generic materials that are not associated with a specific study to Quorum Review for review and approval for generic use. The approval period for generic material is one year, with automatic annual review of the material. A courtesy notification of annual review will be sent prior to the annual review date. Annual review occurs until notification is received to cancel the annual review process.

  45. How should I submit Recruitment or Participant Study Material to Quorum Review IRB?

    Comments Off on How should I submit Recruitment or Participant Study Material to Quorum Review IRB?

    Recruitment and Participant Study Materials can be submitted to Quorum Review IRB using the OnQ Portal, fax or mail. If you have additional questions about an advertisement submission contact the Client Support Team for assistance.

  46. We made modifications to my previously approved material, do I need to submit for review again?

    Comments Off on We made modifications to my previously approved material, do I need to submit for review again?

    Yes, changes to previously approved recruitment or participant study materials should be submitted to Quorum Review IRB for approval prior to implementing the change.

    Spelling corrections and changes to site specific contact information as indicated with space holders are allowed without additional approval from Quorum Review. If no space holders are present, the advertisement should not be modified.

  47. How does Quorum review radio and TV scripts?

    Comments Off on How does Quorum review radio and TV scripts?

    Quorum recommends that scripts are submitted for review before production of the recording is started.

    • After the script has received Board approval and the ad has been recorded, the final recording must be submitted for review prior to broadcast.
    • After approval, radio scripts for live broadcast use must be read exactly as approved.
  48. How do I get/communicate sponsor approval for my recruitment or participant study material?

    Comments Off on How do I get/communicate sponsor approval for my recruitment or participant study material?

    Some sponsors require sites to obtain sponsor/CRO approval for recruitment and participant study materials prior to use. In this case, Quorum requires written documentation from the sponsor or CRO indicating approval. This can be in the form or a letter or email and can be forwarded to Quorum from the site contact.

  49. What does Quorum consider to be protocol study tools?

    Comments Off on What does Quorum consider to be protocol study tools?

    A Protocol Study Tool is a type of participant study material generated by the sponsor that is also described in the protocol as being given to participants as part of the study procedures and is generally used to collect study data. Protocol study tools that are included in the body of the protocol are reviewed as part of the protocol. Protocol study tools that are not part of the protocol or that are identified as appendices are reviewed as participant study material. Since the study tools are reviewed as participant study material, a “Quorum Approved” stamped copy of the protocol study tool is included with the approval document.

  50. What does Quorum consider to be recruitment materials or participant study materials?

    Comments Off on What does Quorum consider to be recruitment materials or participant study materials?

    Participant Recruitment materials include:

    • Printed materials: advertisements in newspapers, bulletin boards, posters, flyers, brochures, press releases, “Dear Patient” letters (for recruiting purposes), informational articles for recruitment purposes, newsletters, study synopses, etc.
    • Audio/Video materials: radio scripts and recordings, public service announcement scripts and recordings, telephone screening scripts, television scripts and recordings, etc.
    • Internet materials: Websites, Internet screening, banner ads, etc.

    Participant study materials include:

    • Diaries, instructions, and medication logs
    • Other written instructions (for following study procedures, using study devices, following study dietary requirements, etc.)
    • Participant information letters
    • Appointment reminder cards, emergency unblinding cards
  51. Do I need to use a submission cover sheet when submitting my recruitment or participant study material?

    Comments Off on Do I need to use a submission cover sheet when submitting my recruitment or participant study material?

    Quorum recommends submitting participant recruitment or participant study materials along with the Recruitment and Participant Study Materials Cover Page. Providing this document allows us to easily determine exactly what is being submitted, so we may properly route your items for processing. Failure to provide this document may result in a delay.

  52. What information should be included in the Consent Form if a Certificate of Confidentiality is Issued?

    Comments Off on What information should be included in the Consent Form if a Certificate of Confidentiality is Issued?

    Participants must be informed in the informed consent document regarding the limitations and protections of the Certificate of Confidentiality. Please notify Quorum Review IRB if you have requested or will be requesting a Certificate of Confidentiality. Also note that if a Certificate of Confidentiality is obtained after the study has commenced, the consent form will need to be revised in order to inform subjects about the Certificate, including its limitation and protections.

    Please contact Quorum Review IRB if you have questions regarding what type of language needs to be included in the consent form. If Quorum is notified that a Certificate of Confidentiality has been or will be obtained, Quorum can also include standard template language in the consent form.

  53. How do I request a non-English consent form?

    Comments Off on How do I request a non-English consent form?

    Upon request, Quorum will obtain a translated consent form for use in consenting participants in their first language. All sites who wish to use a non-English consent form must be specifically approved to do so. To request a translation, please complete a Change Request Form for Sites. Contact Quorum’s Client Support Team for assistance at 1-877-IRB-9883 or clientsupport@quorumreview.com with the following information.

  54. How do I submit safety information and unanticipated problems (e.g. Major Protocol Deviations/Violations, SAEs, IND safety reports) to Quorum?

    Comments Off on How do I submit safety information and unanticipated problems (e.g. Major Protocol Deviations/Violations, SAEs, IND safety reports) to Quorum?

    Quorum requires prompt reporting of all Major Protocol Deviations/Violations and Serious Adverse Events and Unanticipated Problems that occur at the investigator’s site. Notification of IND safety reports, Investigator Brochures, Device Manuals, Package Inserts, FDA Safety Alerts and other protocol level safety documents is required as arranged previously with the study sponsor. Quorum requires the use of its forms when submitting safety information.

    For detailed guidance on submitting safety information refer to the Reporting Safety Information and Unanticipated Problems guidance document. Please do not hesitate to contact us with any questions.

  55. How do I submit a change of address or a new facility?

    Comments Off on How do I submit a change of address or a new facility?

    Quorum does not require the submission of or acknowledge receipt of a revised Form FDA 1572. Instead, Quorum’s Change Request Form for Sites is the best way to report to Quorum any changes in your site’s address, contact information, study coordinator or participant compensation. Quorum’s Change Request Form for Sites allows you to submit major changes. Please take a look at our Instructions for Submitting Study Site Modifications to Quorum Review for guidance on the use of the change forms and any additional requirements for documentation. Contact Quorum’s Client Support Team for assistance at 1-877-IRB-9883 or clientsupport@quorumreview.com.

    The Board will review the information you submit and, if appropriate, issue a new consent form.

  56. How do I renew approval for a study?

    Comments Off on How do I renew approval for a study?

    Quorum will send notification of pending expiration approximately 75 days before your site’s approval is due to expire. If your site is scheduled to remain active after the last day of your current approval period, you must submit a completed Site Status Report at least 45 days before the expiration date. If your site is scheduled to close before the last day of your current approval period, you must submit a completed Site Status Report prior to your expiration date. If a Report is not received by the due date, IRB/REB approval may expire. A Board finding of continuing noncompliance may be reported to the study sponsor and the FDA.

  57. How do I renew IRB approval for a study? How do I renew IRB approval for the investigators involved in a study?

    Comments Off on How do I renew IRB approval for a study? How do I renew IRB approval for the investigators involved in a study?

    Quorum will send notification of pending expiration to the primary study contact approximately 75 days before study approval is due to expire. To renew study approval, please submit a completed Protocol Continuing Review Report at least 60 days prior to the study expiration date. 

    Quorum will send notification of pending expiration to all active sites under Quorum’s jurisdiction approximately 75 days before the site’s approval is due to expire. All sites scheduled to remain active after the last day of their current approval period must submit a completed Site Status Report at least 45 days before their expiration date. All sites scheduled to close before the last day of their current approval period must submit a completed Site Status Report prior to their expiration date. 

    All sites that do not submit a completed report before their expiration date will be scheduled for consideration of suspension and, potentially, termination by the Board. (Please see the Continuing Review and Site Closure FAQ for more information)

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

    Comments Off on Does Quorum review research that will be conducted at Canadian sites

    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.

  59. When will the material I submitted be reviewed by the Board?

    Comments Off on When will the material I submitted be reviewed by the Board?

    Site submission deadlines are 5:00pm Pacific Time, every weekday. Please contact Initial Study Support, Client Support or log in to the OnQ Portal and see Quorum’s IRB/REB Meeting and Review Cycle Timing sheet for more information on timelines.

  60. How often does the Board meet?

    Comments Off on How often does the Board meet?

    The institutional review board/research ethics board currently meets on Tuesday, Wednesday, Thursday and Friday of each week, excluding major holidays (see the Quorum Review Board Meeting Schedule for exact dates) for the initial review of all protocols and consent forms. Quorum also has a daily Board that meets to review amendments and major consent form changes.

  61. How is safety information acknowledged for a Principal Investigator Generated study?

    Comments Off on How is safety information acknowledged for a Principal Investigator Generated 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.

  62. How do I change my Safety Information acknowledgment preference?

    Comments Off on How do I change my Safety Information acknowledgment preference?

    You can change your acknowledgement preferences by submitting the Central Study Information Change Request Form at any time throughout the course of the study. For more information about acknowledgment options or changing acknowledgment preference contact your Study Manager.

  63. What are my options for safety information acknowledgment?

    Comments Off on What are my options for safety information acknowledgment?

    Quorum Review IRB provides sponsors with two types of acknowledgement for Safety Information and Unanticipated Problems:

    • Option one – sponsor acknowledgment only: Quorum Review IRB sends the receipt letter to the sponsor only. The sponsor then accepts responsibility for distributing acknowledgments to the sites as necessary.
    • Option two – study-wide acknowledgment: Quorum Review IRB distributes receipt letter to each site that is open at the time of receipt. For this service, Quorum Review IRB will charge on a per site basis.

    When Quorum Review IRB is reviewing a study on a single-site basis, Quorum Review IRB will always send the Standard acknowledgment as described above. When Quorum Review IRB is acting as a central Ethics Review Board, the sponsor determines the type of acknowledgement investigators will receive for study-wide reports at the time of protocol submission. The sponsor makes this choice on the “Central Study Questionnaire” (CSQ).

  64. What is a standard acknowledgment?

    Comments Off on What is a standard acknowledgment?

    A standard acknowledgment is an acknowledgement of receipt. Quorum Review IRB will stamp the first page of a submitted safety report with the Quorum Review IRB “Received” stamp and return a copy of the stamped first page to the investigator.

    Please note that standard acknowledgment represents receipt only; the standard acknowledgement does not represent Board review of the reported information. The Board will send a separate notice if it is determined upon review that additional action is necessary. In a multi-site study in which a number of investigators submit duplicate information (such as IND Safety Reports), Quorum will return a standard acknowledgment to each investigator who sends a submission.

  65. How do I obtain prospective (prior) permission to implement a protocol waiver?

    Comments Off on How do I obtain prospective (prior) permission to implement a protocol waiver?

    All requests for protocol waivers should be submitted to Quorum on Quorum’s Prospective Waiver Request Form. Quorum will ask for documentation of the sponsor’s approval and each request will be submitted to the Board. Such requests typically are processed through Quorum’s expedited Board reviewers.

  66. Do I need to submit all IND Safety Reports for this study to Quorum?

    Comments Off on Do I need to submit all IND Safety Reports for this study to Quorum?

    Under Quorum’s guidelines, the vast majority of IND Safety Reports, MedWatch Reports and CIOMS Reports (“Reports”) do not need to be reported to Quorum Review. The only Reports that must be submitted are those that qualify as potential unanticipated problems involving risk to participants or others.

    We understand that a number of sponsors and sites have SOPs that require transmission of all Reports to the Board regardless of the nature of the incident reported. If you are submitting a Report to fulfill such a requirement, you can so indicate on the cover page. You will receive an acknowledgment of receipt by Quorum.

  67. What should I do if the sponsor’s guidelines require me to submit a report but under Quorum’s guidelines the event is not reportable?

    Comments Off on What should I do if the sponsor’s guidelines require me to submit a report but under Quorum’s guidelines the event is not reportable?

    Quorum Review IRB recognizes that sponsors, site monitors, CROs or sites may have broader reporting requirements than Quorum’s. You can go ahead and submit such reports. Quorum Review IRB will provide a standard acknowledgement of all documents submitted to fulfill such sponsor and site requirements.

  68. Do sites need to submit reports of adverse events, minor protocol deviations or other minor problems to Quorum Review?

    Comments Off on Do sites need to submit reports of adverse events, minor protocol deviations or other minor problems to Quorum Review?

    As a general rule, no. Examples of events that generally do not need to be reported to Quorum include:

    • Adverse events that, in the PI’s judgment, are not related to the study (such as a participant catching the flu);
    • Adverse events that are anticipated or expected as part of the study (such as nausea in a trial of a chemotherapy drug);
    • IND Safety Reports that, in the PI’s judgment, do not adversely affect the conduct of the PI’s study at his/her research facility;
    • Minor protocol deviations (such as study visits performed slightly out of window);
    • Minor research participant complaints that are adequately resolved by the research staff.

    At the time of periodic site review, Quorum Review IRB’s “Sites Status Report for Periodic Site Review” will ask whether the investigator believes that a change in the research plan or the consent form is necessary in light of these unreported events. If the investigator recommends a change in the research or the consent form, Quorum Review IRB might request that the investigator submit the log or other summary of adverse events and protocol deviations for further consideration.

  69. What are some examples of potential Unanticipated Problems?

    Comments Off on What are some examples of potential Unanticipated Problems?

    Quorum considers major protocol deviations and SAEs to be potential Unanticipated Problems. Additional examples of potential Unanticipated Problems that should be promptly reported include:

    • Unresolved research participant complaints
    • Adverse audit or enforcement actions
    • Breaches of privacy/confidentiality
    • Unauthorized use or disclosure of protected health information (PHI)
    • Loss of study records
    • Disappearance of study drug
    • Research staff misconduct affecting the research
    • Incarceration of a research participant
    • Injury sustained by research staff relating to the study
    • Suspension of principal investigator’s medical license
    • Higher than expected volume of adverse events
    • Higher than expected volume of protocol deviations
    • Higher than expected volume of participant drop-out rates
    • Complaint from a research participant involving an unanticipated risk that cannot be resolved by the research staff
    • New findings that may influence a research participant’s willingness to continue participation in the study
  70. What is a “minor” protocol deviation?

    Comments Off on What is a “minor” protocol deviation?

    A minor protocol deviation is a protocol violation that, in the investigator’s judgment, does not adversely affect the risk/benefit ratio of the study, the rights, safety, or welfare of the participants or others, or the integrity of the study. Examples of minor protocol deviations include:

    • Study procedure conducted out of timeframe
    • Study visit out of timeframe
    • Participant failure to initial every page of the consent form
    • Copy of consent form not given to participant during informed consent process
    • Site over-enrollment
    • Participant failure to return diary
    • Missing original signed consent, but have a copy of the participant signed consent

    Minor protocol violations do not need to be reported to Quorum Review IRB.

  71. What is a “major” protocol deviation?

    Comments Off on What is a “major” protocol deviation?

    Under Quorum’s guidelines, examples of major protocol deviations include:

    • Failure to obtain informed consent
    • Informed consent obtained after the initiation of study procedures
    • Omitting study procedure(s) required by approved protocol
    • Performing a study procedure that is not outlined in the IRB-approved protocol
    • Failure to report a Serious Adverse Event
    • Drug dispensing/dosing error
    • Failure to securely control the study product
    • Enrolling participants outside of inclusion criteria
    • Failure to follow a Safety Monitoring plan
    • Study visit outside of window, only if in the opinion of the investigator, if affects the safety or welfare of the research participants or others, the rights or participants or other or the integrity of the study design.
    • Use of an unapproved consent form
  72. When should sites report a protocol deviation to Quorum?

    Comments Off on When should sites report a protocol deviation to Quorum?

    Quorum Review IRB requires sites to report only major protocol deviations. A “major” protocol deviation is a protocol deviation that adversely affects the:

    • Safety or welfare of research participants or others;
    • Rights of research participants or others; or
    • Integrity of the study design

    Investigators must report a major protocol deviation to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence. Please use Quorum Review IRB’s Major Protocol Deviation Report form.

  73. When should sites report serious adverse events to Quorum?

    Comments Off on When should sites report serious adverse events to Quorum?

    Quorum Review IRB requires sites to submit reports of Serious Adverse Events (SAEs) that meet the criteria below:

    • Serious;
    • Unanticipated; and
    • Related to the study product or study procedures.

    If an adverse event meets all three requirements, it is a reportable SAE. An “unanticipated” adverse event is one that is not identified in nature, severity, or frequency in the relevant safety documents(s) for the study product or is not identified as a possible risk in the study protocol or the informed consent form for the study. Investigators must report an SAE to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence. Please use Quorum Review IRB’s Safety Information & UP Report form. An adverse event that does not meet all three reporting criteria listed above does not need to be reported to Quorum.

  74. What types of events should be reported to Quorum as potential Unanticipated Problems?

    Comments Off on What types of events should be reported to Quorum as potential Unanticipated Problems?

    Quorum considers the following events to be potential Unanticipated Problems and requires investigators to promptly report each of the following events within ten (10) business days of becoming aware of the event’s occurrence:

    • Serious adverse events
    • Major protocol deviations/violations
    • Research participant complaints
    • Adverse audit or enforcement actions (e.g., Form FDA 483, FDA Warning Letters, FDA Establishment Inspection Reports (EIRs), adverse Sponsor audit findings, etc.)
    • IND Safety Reports that qualify as unanticipated problems involving risk to participants or others
    • New/updated safety information that may increase risk to participants
    • Reports, publications, or interim results or findings
    • Recalls, wthdrawals, or clinical holds
    • Any other incident that could qualify as an unanticipated problem involving risk to participants or others, such as the loss of a laptop with confidential study data (more examples below)
    • Any incident that must be reported according to the policies of the sponsor or site

    For additional guidelines regarding the types of incidents that require prompt reporting, refer to the Safety Information and Unanticipated Problems Reporting Guidelines.

  75. How should I submit safety information and potential unanticipated problems to Quorum Review IRB?

    Comments Off on How should I submit safety information and potential unanticipated problems to Quorum Review IRB?

    Safety information and other reportable events can be submitted to Quorum Review IRB using the OnQ portal, fax or mail. All safety information should be submitted using the appropriate report forms found on the Quorum website. Quorum expects investigators to report safety information and other reportable events to Quorum Review IRB within ten (10) business days of becoming aware of the event’s occurrence.

  76. 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.

  77. 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.

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

    Comments Off on Does Quorum require a CV for each sub investigator?

    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.

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

    Comments Off on What type of information is required on an investigator’s CV?

    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.

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

    Comments Off on What are the most common errors Quorum sees on site submissions?

    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.

  81. 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.)
  82. What submission documents are required by Quorum?

    Comments Off on What submission documents are required by Quorum?

    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.
  83. How is safety information acknowledged for a Principal Investigator Generated Study?

    Comments Off on How is safety information acknowledged for a Principal Investigator Generated 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.

  84. 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.

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

    Comments Off on Will Quorum review my study if I am listed on the IND?

    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.

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

    Comments Off on Does Quorum have any recommendations regarding the protocol or consent form?

    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.

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

    Comments Off on Are there any extra steps during the submission process for Principal Investigator Generated Studies?

    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.

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

    Comments Off on What are investigators expected to submit to Quorum for Principal Investigator Generated Studies?

    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.

  89. What is Investigator Generated research?

    Comments Off on What is Investigator Generated research?

    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.

  90. Can I still use the regular SIQ?

    Comments Off on Can I still use the regular SIQ?

    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.

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

    Comments Off on What is required for an observational registry site submission?

    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.

  92. Do you require 1572’s?

    Comments Off on Do you require 1572’s?

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

  93. 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.

  94. 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.

  95. 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.
  96. 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.
  97. What kind of training qualifies as “Human Research Participant Protection Training”?

    Comments Off on What kind of training qualifies as “Human Research Participant Protection Training”?

    Quorum expects Principal investigators to be responsible for the conduct of research trials and all associated research facilities consistent with the IRB-approved protocol, applicable law and regulations, applicable federal and ICH Guidelines for Good Clinical Practice, and ethical principles of the Belmont Report.

  98. What documentation is required for a change in principal investigator?

    Comments Off on What documentation is required for a change in principal investigator?

    A change in principal investigator must be reviewed by the Board and cannot be submitted for review until all of the following documents are received:

    • A letter from the departing principal investigator explaining why he/she is no longer able to perform the role of principal investigator (if the departing principal investigator is not available to provide a letter Quorum will alternatively accept a written explanation from the new principal investigator).
    • “Change Request Form for Sites”, “Site Information Questionnaire” form or “Observational Registry Site Information Questionnaire” form, if applicable.
    • A current (within two years), dated CV for the new principal investigator. Effective January 2008, the PI needs to submit a CV only once. We do not need additional copies of the CV for subsequent site submissions.) For observational registry studies a CV is not required.
    • Supplemental material as appropriate based on “Change Request Form for Sites” responses (for example, FDA Audit information, letters of explanation, etc.).
  99. What kinds of changes can I make using the Change Request Form for Sites?

    Comments Off on What kinds of changes can I make using the Change Request Form for Sites?

    The Change Request Form for Sites may be used to request the following changes:

    • Change in Additional Research Facility
    • Change in Participant Emergency Numbers
    • Change in Site Contact Information
    • Change in Compensation of Study Participants
    • Request for Translated Consent Form
    • Change in Primary Facility Business Name
    • Change in Principal Investigator

    Download a copy of the Change Request Form for Sites here

  100. Will Quorum send me an approval document when I submit a change form indicating that the study coordinator at my site has changed?

    Comments Off on Will Quorum send me an approval document when I submit a change form indicating that the study coordinator at my site has changed?

    Quorum only sends approval documents to sites when the change that has been submitted affects the consent form (such as an address or telephone number change). For all other changes, if the changes are submitted using the OnQ Portal you will receive an acknowledgement that the request was received. Quorum staff will update our records accordingly.

  101. 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.

  102. 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.

  103. 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.
  104. 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.