Institutional Review Board
Event Report Form
(Reportable Unanticipated Adverse Event/Problem)
Investigators are required to promptly report adverse events or other problems involving risks to subjects or others that are an unanticipated problem and serious and related or possibly related to the research protocol. Unanticipated problem suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
All other events are to be submitted at the time of continuing review, or are not required to be submitted to the IRB at all, according to IRB reporting policy.
STUDY INFORMATION1. IRB Number:
2. Protocol Title:
3. Principal Investigator:
Phone: / () -
E-mail:
4. Event Reference # or Subject ID #:
FULL BOARD REVIEW? Yes No ______
Signature of IRB Chair or Designee
THIS SECTION IS FOR THE IRB RESPONSE WHEN THE EVENT
IS GIVEN EXPEDITED REVIEW
The IRB evaluated this information by expedited review and concluded the following:
No changes required:
Anticipated risk already described in consent form and not indicative of unusual concern or unacceptable frequency for this type of event.
Anticipated risk of existing condition/disease(s).
Insufficient data to determine foreseeable risk exists.
The IRB does not review events for studies that are closed to enrollment with no participants on study treatment. The information was filed.
The IRB does not review events for studies that have been terminated. The information was filed.
Other:
Signature of IRB Chair, Vice-Chair or Designee Date
TYPE OF EVENTIndicate the type of event/problem (check all that apply):
Event that is: 1) unanticipated; and 2) serious
and 3) related/possibly related.
A serious adverse event is one that is fatal or life-threatening, permanently or significantly disabling, or otherwise defined by regulations, as determined by the CHRCO Principal Investigator (i.e., an unanticipated problem to the research)
An emergency protocol deviation taken without prior IRB review to eliminate apparent immediate hazard to a research subject
An accidental or unintentional deviation to the IRB-approved protocol that involved risks
IND Safety Report (unanticipated, and serious and related/possibly related)
Unanticipated Adverse Device Effect
Specific protocol-defined events that require prompt reporting to the sponsor
Change in FDA labeling or withdrawal from marketing of the study drug, device, or biologic used in this research protocol
Other / Information that indicates a change to the risks or potential benefits of the research. For example,
§ An interim analysis or safety monitoring report indicating that frequency or magnitude of harms or benefits may be different than initially presented to the IRB; or
§ A paper published from another study indicating that the risks or potential benefits of the research may be different than initially presented to the IRB.
Sponsor imposed suspension for risk
Breach of confidentiality
A complaint of a subject that indicates an unanticipated risk, or any complaint that cannot be resolved by the research staff
EVENT INFORMATION
1. Location of Event:
At CHRCO or local site (e.g., local clinics, CHORI).
At another site in a multicenter study in the same protocol. Site:
At another site in a multicenter study in a different protocol. Site:
2. Is this study permanently closed to enrollment at CHRCO/local site? YesNo
3. Is anyone at this site still on study treatment (drugs, device, intervention)? YesNo
4. Indicate the type of report: / Initial report
Follow-up report Date of initial report:
5. Date of this problem/event or report:
6. Date Principal Investigator aware of event/problem (if applicable):
7. Identify drug/biologic/device/treatment/intervention:
8. Does the study have an independent Data Safety Monitoring Board (DSMB), Data Monitoring Committee (DMC), or other study monitor? YesNo
If Yes, choose one of the following: DSMB/DMC review of event/problem is attachedDSMB/DMC has not reviewed event/problemDSMB/DMC review is pending
DESCRIPTION OF EVENT
1. Age of subject: Gender of subject: Male Female
2. Describe the event/problem.
3. Explain clearly why the event described above represents a "problem" for the study and why it is "unanticipated."
4. Has the same problem/event occurred previously in this study (at any site)?
No Yes If yes, the number of times this event has occurred study-wide?
OUTCOME AND RESPONSE TO EVENT
Is the problem/event ongoing? YesNo If no, answer the following:
(a) Date the problem/event ended:
(b) Outcome of the problem/event: (check all that apply)
Subject was not adversely affected by the problem/event
Resolved spontaneously
Resolved with treatment
Resulted in prolonged hospitalization
Resulted in permanent disability
Subject continued study drug or intervention
Subject temporarily discontinued study drug or intervention
Subject discontinued study drug or intervention
Participant withdrew or was withdrawn from the study
Other – Specify:
Participant died – If checked, provide below a detailed description of the circumstances that led to the death.
1. Describe below the treatment, if any, provided to subject: N/A – no treatment
OBSERVED VS. ANTICIPATED FREQUENCY OR SEVERITY OF EVENT
1. Are the specificity, frequency, and severity of this problem/event consistent with the protocol and consent document? Yes No
2. Are the specificity, frequency, and severity of this problem/event consistent with the investigator brochure, package insert, or device manual? N/AYesNo
3. If no to question 1 or 2, explain below why not.
4. If the event seems to be occurring more frequently than anticipated, do you think it is necessary to explore how frequently this event has occurred compared to the frequency the event was anticipated to occur? Yes No
CHANGE IN STUDY PROCEDURES
1. Should the consent/assent documents be revised? NoYes
If yes, submit a revised consent form (with changes tracked) and an Amendment/Addenda Application Request Form with this report.
2. Should the protocol be revised? NoYes
If yes, submit a revised protocol (with changes tracked) and an Amendment/Addenda Application Request Form with this report.
3. Should the research be suspended or terminated? NoYes
If yes, explain below procedures for orderly suspension or termination of the research.
4. Should currently enrolled subjects (and/or their parents/guardians) be notified about this problem/event? N/A – None currently enrolled at local site NoYes
5. Should previously enrolled subjects (and/or their parents/guardians) be notified about this problem/event? N/A – No one enrolled at local site to date (enrollment is open).
No Yes
6. If yes to question 4 or 5, explain below how subjects will be notified. If an addendum to the consent form will be used, submit the consent addendum and an Amendment/Addenda Application Request Form with this report.
Certification of the Principal Investigator: My signature certifies that all necessary information has been assessed and the risk-to-benefit ratio continues to be acceptable.
Principal Investigator’s Signature Date
Via US Mail Via E-mail
Institutional Review Board
Children's Hospital & Research Center Oakland
747 52nd Street
Oakland, CA 94609-1809
Telephone: (510) 428-3754 Fax: (510) 597-7151
Event Report Form – 07-08 Page 4 of 5