Institutional Review Board
3624 Market St., Suite 301 S
Philadelphia, PA 19104-6006
Phone: 215-573-2540
Reportable Event Form: Non-Medical Events
FULL PROTOCOL TITLE:
PROTOCOL #:
PENN PRINCIPAL INVESTIGATOR:
IRB APPROVAL EXPIRATION DATE:
Please use this form to report non-medical events that meet the following criteria:1) unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents and the characteristics of the subject population being studied;
2) definitely or probably related to participation in the research; and
3) suggests that the research places subjects or others at greater risk of harm than was previously known or recognized.
Common examples of non-medical events that should be reported are:
· A complaint from a research subject that cannot be resolved by the research team;
· A breach of confidentiality
· An incarceration of a participation when the research was not previously approved for the enrollment of prisoners under Subpart C and the investigator believes it is in the best interest of the subject to remain on the study;
· A manufacturing error that was not caused by the study team but posed potential risk to subjects; and
· Research staff exposure to unexpected risks
The IRB requires researchers to submit reports that meet the above criteria within 10 days of the time the event becomes known to the study team with one exception. If the adverse event involved the unforeseen death of a subject and indicated participants or others are at increased risk of harm, report in three days.
Please note that a single Reportable Event Form can be completed for multiple subjects if the subjects were affected by the same event. If you need to report multiple separate Reportable Events, please contact the IRB in advance to determine the best way to draft your report(s).
If you have to report a medically-based adverse event, please use the Reportable Event Form: Medical Adverse Events. Additional information on reportable events can be found in the IRB SOPs or on the Reportable Events Guidance page of the IRB website.
***The IRB should not receive any identifiable subject information. All supporting documentation should be de-identified prior to submission. Additionally, when emailing with the IRB about any reportable event, please ensure that all email correspondence is clear of identifiable subject information. ***
1. Study Contact: In addition to the Principal investigator, who should the IRB contact with questions about this event? Note: If Penn is serving as the Single IRB (IRB of Record) for a multi-site protocol, please list the name and contact information for the designated Point of Contact who is creating and submitting this reportable event in HSERA.
Name: / Telephone:
Email:
Is this a multi-site study where Penn is serving as the Single IRB or IRB of record for external sites? / YES NO
If yes, did the event occur at Penn or at a site that is relying on Penn as the IRB of record? / YES NO
If yes, please identify the site where the deviation occurred in the text box below and provide the names, email addresses & phone numbers for the site Investigator and Study Contact that the IRB can contact with questions related to the substance of the deviation.
2. Report Status: Please indicate whether this is the first time this event has been reported to the IRB or if it is a follow up report
Initial Report OR Follow-up Report
For follow-up reports, please list the date the initial report was submitted to the IRB and, if applicable, provide the HS-ERA confirmation code for the report:
3. Event Summary: Please provide a narrative summary of the event that occurred. The summary should include the following elements:
· The date the event occurred;
· The date the team became aware of the event;
· A description of the event and the subjects that were affected; and
· The immediate and follow up actions that were taken in response to the event
In the following text box, please indicate whether the event is considered resolved or unresolved. If the event is unresolved, please indicate what additional actions are expected to be taken to resolve the event:
4. Supporting Reports: Please identify any other entities that have been informed of this event (e.g. Medical Monitor, Sponsor, Privacy Officer, Office of General Counsel, DSMB, FDA, Funding Agency, Other IRB, etc…).
Please provide the IRB with copies of any event-related correspondence (including email correspondence) from the above mentioned entities. All IRB submissions for Greater Than Minimal Risk research must include a complete list of documents being submitted for review as they should appear in your determination letter (document name, version #, date):
Please identify any other entities responsible for monitoring the protocol that may need to be informed of the event (lead site investigator, sponsor, other study sites, 3rd parties subject to a contractual obligation, etc.) and whether you plan to notify them of the event:
5. Response to the Event:
Does the event(s) require any changes to the currently approved study conduct or document(s)? Have you been informed that revisions to study documents are planned (i.e. from the Sponsor)? / YES NO
If Yes, please submit an amendment to the IRB.
If No, please explain why these events do not warrant revision of the current study conduct and/or document(s):
Do current and/or past subjects need to be notified of this event? / YES NO
If Yes, please briefly describe how you intend to accomplish this
If No, please provide justification for not notifying subjects
If this event involved a subject enrolled at Penn (or a site that is relying on Penn as the IRB of record), please provide a description of what information has been shared with the subject and whether this communication has been documented. Please also detail what actions may still be taken with the subject in response to the event (e.g. subject will be withdrawn, additional follow-up procedures, additional monitoring will occur, etc.)
6. Is the event considered unanticipated/unexpected? An event is unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol - related documents and the characteristics of the subject population being studied.
Does the Penn Principal Investigator assess this event as unexpected or unanticipated? *If you are reporting an event that occurred at a site that is relying on Penn as the IRB of record, please provide the local PI’s assessment rather than the Penn PI’s assessment* / YES NO
Please provide a narrative summary of the Principal Investigator’s Rationale for this unanticipated/unexpected assessment:
7. Is the event considered related to the research? An event is considered related to the research if the cause of the event is deemed related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident may have been caused by some aspect of research participation).
Does the Penn Principal Investigator assess this event as related to the research? *If you are reporting an event that occurred at a site that is relying on Penn as the IRB of record, please provide the local PI’s assessment rather than the Penn PI’s assessment* / YES NO
Please provide a narrative summary of the Principal Investigator’s rationale for this relatedness assessment.
8. Risk/Benefit Assessment: In light of this event, please re-assess the study overall and provide your rationale for whether or not the protocol unnecessarily exposes subjects to risk and whether risks to subjects remain reasonable in relation to the anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result from this research.
Completion of reportable event: Please attach this completed form a Reportable Event application in the HSERA system along with the other requirement documents and submit for IRB review.
By submitting this completed form, the principal investigator and the person completing the form (if other than the investigator) certify that he/she has disclosed to the IRB all relevant information that might affect re-approval of this study. (Click to review PI responsibilities)
Date of submission:
UPENN ORA 2017 Page | 3