Reportable Events

Events requiring prompt reporting to the IRB including Unanticipated Problem involving risks to subjects or others reporting requirements

What is a Reportable Event?

A reportable event is an incident that has the potential to be classified by the IRB as an unanticipated problem posing risks to participants or others. In general, an incident is determined to be a reportable event when it is both (1) unexpected in terms of nature, severity or frequency, and (2) related to participation in the research.

How do I submit a Reportable Event?

There are two different reportable event forms downloadable from the forms page. (The use of these forms is required starting June 1, 2016)

Regardless of whether your study was initially submitted through the online application system (HS ERA) or is still documented on paper, the request should be submitted using HS-ERA:

  1. Log into In HS ERA.
  2. Under “My Submissions” in the blue column on the left side of the screen choose “Create”.
  3. Then select “Reportable event”.
  4. Search for and select the relevant protocol on the next page. If your study was not submitted through HSERA the Create Reportable Event page provides a search bar for you to identify your protocol number and will allow you to submit a reportable event for that study through the electronic system
  5. Attach the completed form and any related documents to the reportable event submission
  6. Once the PI approves the submission it will be received by the IRB for review. When submitting via HSERA, a physical signature is not required on the form.

How do I determine if an event that occurred on my study is a Reportable Event?

Below are the most commonly reported events and descriptions of the criteria used to determine whether the event is reportable

(1) Adverse Medical Events which are both related and unexpected:

  • An event is considered “related to the research procedures” if the cause of the event is deemed probably or definitely related to the investigational product or a procedure that was performed for the purposes of the research.
  • A “suspected adverse reaction” could be considered a reportable event when there is reasonable possibility that the drug/investigational product caused the adverse event. For these reporting purposes, reasonable possibility means there is evidence to suggest a causal relationship between the drug/investigational product and the event
  • If the Sponsor determination notes a causal relationship between the event and the investigational drug/product without required revisions to the consent form or other study documents and/or the report indicates that the event does not alter the risk profile of the investigational drug/product, the event should not be classified as reportable
  • An event is “unexpected” if it is not accurately reflected in the protocol-related documents, such as the IRB-approved research protocol, the investigator’s brochure/package insert, or, the current IRB –approved informed consent document. An event can also be considered unexpected if is not listed at the specificity or severity that has previously been observed and described in the protocol-related documents.
  • “Unexpected” also refers to events that are mentioned in the investigator’s brochure/package insert as occurring with a class of drugs or as anticipated, but, are not mentioned as to have been

(2) Unanticipated adverse medical device reaction:

Any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

(3) Non-Medical Events - the IRB also requires prompt reporting of the following events:

  • Withdrawal from marketing for safety concerns of a drug, device, or biologic used in a research protocol.
  • Complaint of a participant when the complaint indicates unexpected risks or the complaint cannot be resolved by the research team
  • Breach of confidentiality
  • Incarceration of a participant when the research was not previously approved under Subpart C and the investigator believes it is in the best interest of the subject to remain on the study
  • Premature completion of a study for any reason

Once I determine an event is Reportable, when should I submit the Reportable Event?

The IRB requires investigators to submit reports within 10 working days of discovery (with one exception) for events that meet reporting criteria.

***Exception to this rule:

If the adverse event involved a death and indicates that participants or others are at increased risk of harm, investigators are required to submit a report to the IRB within 3 days. If you do not have enough information to complete the Reportable Event form within this timeframe, you still must submit a Reportable Event Form. You should indicate that a follow up report will be provided once additional information has been obtained.

What should I do if I determine that an event does not meet the definition of a Reportable Event?

  • Submit a narrative summary of the events that occurred at the time of continuing review. This summary should include the rationale for why the event was not reportable.
  • Submit routine, periodic reports (e.g. DMC reports that indicate no changes, sponsor annual progress reports) to the IRB at continuing review

How does the IRB review Reportable Events?

IRB staff, members, and chairs will review your report to determine if it is complete. IRB personnel may ask you to provide additional information regarding the event.

If the IRB determines that the event did not meet the definition of a reportable event, the IRB will either return the event to you with notification that it does not meet our reporting criteria or issue an acknowledgment of the report.

If the event, meets the definition of a reportable event, the IRB will review the report to determine if it meets the definition of an unanticipated problem involving risk to participants or others. This may include review at a convened IRB meeting. Events that are determined to be unanticipated problems involving risks to participants or others will be reported according to SOP CO 602.

In addition, the IRB may determine whether any of the following are appropriate:

  • Accept report or with no additional requirements
  • Approve investigator’s proposed change
  • Administrative hold on the study pending IRB receipt of further information from the PI in a time period not to exceed 90 days
  • Modification of the protocol
  • Modification of the information disclosed during the consent process
  • Providing additional information to current participant the information may relate to the participant’s willingness to continue participation
  • Making arrangements for clinical care outside the research or additional follow-up for participants
  • Providing additional information to past participants
  • Requiring current participants to re-consent to participation
  • Alteration of the frequency of continuing review
  • Observation of the research or the consent process
  • Requiring additional training of the investigator
  • Notification of investigators at other sites
  • Obtaining additional information
  • Termination or suspension of the research; if this action is taken, the IRB Director will notify the Institutional Official to initiate any reporting actions; if the IRB does not consider the event to represent an unanticipated problem involving risks to participants or others, no further action

What should I do if I am not sure if an event meets the criteria for a Reportable Event?

The IRB will accept reports when the investigator is unsure whether the event should be reported, and the IRB will review such reports to determine whether the event meets the threshold for an unanticipated event presenting risk to the participant.

Unnecessary reporting of events or problems that do not potentially affect the rights, welfare or safety of subjects in the study may impair the IRB’s ability to review and respond in a timely manner to actual situations where subject rights, welfare or safety are threatened.

The IRB will not acknowledge safety reports or bulk AE submissions that do not meet the criteria outlined above. These submissions will be returned.

The IRB encourages study teams to communicate this policy to sponsors and should use this document for verification as necessary.

Policy Reference:

Penn IRB Policy RR404 , Section 3.2

Reportable Events Process Flow Chart

Steps:

Submitting to the IRB

HS-ERA Link: https://hsera.apps.upenn.edu/hsProtocol/jsp/fast2.do

Please report both paper protocols and HS ERA protocol through the HS ERA portal

Submission Process

Click "Create" and "reportable event" and either select an HS-ERA protocol from the picklist or enter the protocol number for the paper submission in the text box provided.

An initial screening will be completed by the submitter to determine if the event meets IRB reporting criteria (event is BOTH unexpected AND related).  If an event is determined not to meet reporting criteria, the submitter may override the system and still submit the event for review by the IRB.

NOTE: All reportable events are submitted via HS-ERA, whether the submission is electronic or paper.

Paper Studies

All reportable events are submitted via HS-ERA.  See instructions in "Submission Process" for how to submit for a paper protocol.

Who do I contact with questions?

If you need assistance submitting a reportable event, please contact anyone listed as a Senior Administrator on our directory page

Completing the Submission

What is required to be submitted with a reportable event?

The reportable event form must be completed and the submitter must verify whether any affiliated study documents (i.e. protocol, consent form, Investigator's Brochure) will be revised as a result of the event.

NOTE: Any revisions that will be submitted in response to a reportable event will need to be submitted under a separate modification request, not within the reportable event submission.

Who do I contact with questions?

If you need assistance completing the reportable event form, please contact anyone listed as a Senior Administrator on our directory page

Confirmation Page

What do I include with the reportable event submission?

 

 

  • Please indicate whether there are any additional reports that contain relevant information regarding the event. You will be asked to provide any applicable documentation which may include the Sponsor’s determination, the Medical Monitor’s assessment, etc. 
  • Any additional notes from the Principal Investigator related to the reportable event should be provided.
  • A risk asessment from the (IND/IDE) Sponsor and Principal Investigator of the event is required to be detailed for IRB review.

IRB Review Process

What happens during IRB review?

 

 

The IRB will consider the reportable event and either contact the PI/study team for further information if needed or may approve the request.  A standard acknowledgement letter for the event will be forwarded upon review.  The acknowledgement letter may indicate the event is scheduled for convened review or that no further action is required. 

Responding to Issues Raised By the IRB

IRB notification(s) for additional information required

 

 

If additional corrective action(s) or other responses are required by the IRB, they will be requested via the formal letter that summarizes the issues identified by the convened board or the authorized designee of the IRB (for expedited reviews).  The submission will be returned in HS-ERA for the study team to address the issues raised by the IRB. It is recommended that a cover letter be included with the response submission so that the IRB can clearly identify how each stipulation was addressed.

 

Who can I contact with questions?

If you require assistance during the IRB review process or interpreting an IRB requirement in your approval letter, either contact a IRB Staff Member for general assistance or contact the IRB Staff Member who signed the approval letter.