FAQ Categories Safety Reporting

Archive

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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
  13. 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.

  14. 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
  15. 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.

  16. 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.

  17. 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.

  18. 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.