Guidance

Study-Specific Adverse Event (AE) Reporting Plans

IRBMED
Jul 22, 2020 2:30 am
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The IRBMED Standard Adverse Event (AE) Reporting Timetable is designed to accommodate a wide range of study designs and risk levels. These standard guidelines apply only to IRBMED reporting; they do not apply to reporting that may be required by sponsors, or other internal or external oversight agencies or departments. 

An alternative AE reporting plan, one specific to the study, may be appropriate for certain studies.

The initial application for research includes a section where the researchers describe the AE reporting plan they intend to follow. The default selection is the standard IRBMED adverse event reporting plan, however this can be modified to indicate a study-specific AE reporting plan. If a study has been approved with the standard AE reporting plan and later modified to a study-specific plan via an amendment, the standard reporting plan must be followed until the IRB approves the modification.

If your study has an IRB-approved Study Specific AE Reporting Plan:

  • Refer to the IRB-approved documents for the specific study that includes a detailed plan for AE reporting. Follow the directions in the plan for reporting to oversight bodies (e.g. DSMB, sponsor, IRB).
  • To report adverse events not included in the study-specific AE reporting plan, follow the Standard AE Reporting Timetable to determine if and when to report.

  • Applicability

    Researchers may propose an alternate to the IRBMED Standard AE Reporting timetable. A study-specific plan can still provide subject protections while reducing study team burden by eliminating the requirement to report AEs that are not attributable to the research (i.e. unrelated AEs or expected AEs attributable to the subjects' underlying condition).

    However, note that the Standard timetable does not expect reports of non-serious, unrelated AEs. The IRB will review assess the appropriateness of the study-specific AE reporting plan.

  • Suggestions for Writing a Study-Specific Adverse Event Reporting Plan

    A study-specific AE reporting plan should describe which AEs will be reported and a time-frame for reporting. Indicate also AEs or types of AEs that will not be reported.

    Potential Unanticipated problems involving risks to subjects or others (UaPs or UPIRSOs) are required to be reported promptly. Unanticipated Problems meet all of the following criteria:

    • Unexpected (in terms of nature, severity, or frequency);
    • Related or possibly related to participation in the research; and
    • Suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized.

    Often, predictable events, or expected AEs for the population being studied that are not attributable to the research can be indicated as events that will not be reported as AEs, even if the data is collected for study purposes (e.g. death in an elderly population with a history of stroke and diabetes).

    Consider separating aspects of the AE reporting plan into categories when appropriate (e.g. separate descriptions or tables for different cohorts). Designate what will and will not be reported using terminology as general or as specific as is appropriate.

    The AE reporting plan may be submitted as a standalone document, as part of a data and safety monitoring plan (DSMP), or as part of a protocol.

  • Examples

    Example 1

    Only related adverse events will be reported. Related means events that are caused by the research itself, not the disease or population under study. Reports will be sent to the IRB as follows:

    • Adverse event defined as "serious" will be reported to the IRB within 7 days
    • Non-serious adverse events (mild/moderate, grade 1 or 2, e.g. emotional upset not requiring intervention) will be reported to IRB in conjunction with the next Scheduled Continuing Review
    • Unanticipated problems that are related to the study and indicate risks to subjects, and are not also Serious Adverse Events will be reported to the IRB within 14 days
    • A privacy violation or breach of confidentiality will be reported to the IRB within 7 days and to the Corporate Compliance office within 24 hours

    This example may be appropriate for studies when few adverse events are expected and there is little reason to believe unexpected AEs will be related to the research.

    Example 2

    • Wherever the protocol indicates reports to the sponsor will be made within 24 hours, the corresponding report to the IRB will be made according to standard AE reporting plan
    • Non-serious Adverse Events (mild/moderate, grade 1 or 2) will not be reported to the IRB

    This may be appropriate for a study where very many adverse events are expected, such as drug or device trials in subjects who have serious, ongoing illnesses such as cancer. Such subjects may suffer frequent health setbacks under either a research or standard-of-care treatment; and such studies usually include frequent and rigorous data and safety monitoring, so frequent reports to IRB of individual AEs may not substantively add to the protection of subjects, unless they constitute unanticipated problems involving risks to subjects or others.

Units: Institutional Review Boards (IRBMED)
Topic: Adverse Events & Other Reportable Information and Occurrences eResearch Regulatory Management (eRRM) Investigator & Study Team Responsibilities
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Edited By: [email protected]
Last Updated: July 24, 1:30 PM

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