THE GEORGE WASHINGTON UNIVERSITY
Office of Human Research- Institutional Review Board
ohrirb@gwu.edu
Phone: 202-994-2715
http://humanresearch.gwu.edu/
PROMPTLY REPORTABLE NEW INFORMATION FORM (HRP-204)
IRB #:
STUDY TITLE:
VERSION DATE, IF APPLICABLE:
PRINCIPAL INVESTIGATOR:
STUDY SPONSOR:
SECTION I. TYPE OF EVENT/PROBLEM
Please report the items in this section to GW’s IRB within 5 business days of knowledge of event.
Check One:
Initial Report
Follow-Up Report (Date of Initial report:
Type(s) of Event:
Information that indicates a new or increased risk, or a safety issue
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New information (ex: an interim analysis, data safety monitoring report, IND safety report, publications indicating a
new risk, sponsor report, or investigator finding) that indicates an increase in the frequency or magnitude of a previously
known risk, or uncovers a new risk.
An investigator brochure, package insert, or device labeling revised to indicate an increase in the frequency or
magnitude of a previously known risk, or describe a new risk
Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol
Protocol deviation that harmed subjects or others or that indicates subjects or others might be at increased risk of harm
or affects the integrity of the research data
Complaint of a subject that affects the willingness of subjects to continue with study or indicates subjects or others
might be at increased risk of harm or at risk of a new harm
Any changes significantly affecting the conduct or integrity of the research
Any harm experienced by a subject or other individual, which in the opinion of the investigator, are
unexpected and possibly/probably/definitely related to the research procedures
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A harm is “unexpected” when its specific or severity are inconsistent with risk information previously reviewed and
approved by the IRB in terms of nature, severity, frequency, and characteristics of the study population.
A harm is “possibly related” to the research procedures if in the opinion of the investigator, the research procedures may
have possible caused the harm.
Noncompliance with the federal regulations governing human research or with the requirements or
determinations of the IRB, or an allegation of such non-compliance
Protocol deviation made without prior IRB approval to eliminate an apparent immediate hazard to a
subject
Breach of confidentiality
Unresolved subject complaint
Incarceration of a subject in a research study not approved to involve prisoners
Unanticipated adverse device effect
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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 (21 CFR 812.3(s))
Suspension or premature termination by the sponsor, investigator, or institution
Audit, inspection, or inquiry by a federal agency
Written report from a federal agency (e.g., FDA Form 483)
State medical board action
Promptly Reportable New Information Form (HRP-204)
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Other information the sponsor/CRO has directed the PI to report to the IRB, even if not on this list.
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Please use this when none of the above issues apply, but you are being required to submit to the IRB
Information not listed above should be reported in summary form at time of Continuing Review.
SECTION II. EVENT DESCRIPTION
Date(s) of Event/Problem:
Subject(s) ID:
(DO NOT include personal identifiers)
Subject(s) Age:
Subject(s) Gender:
1. Provide detailed description of the event, including:
(a) a description of the event, including whether this is an internal event involving a GW patient/ subject, staff, student,
affiliate, other individual, or an external event;
(b) the timeline for the event;
(c) how and/or why it occurred;
(d) if applicable, why, in your opinion, the event is unanticipated and possibly/probably/definitely related. For medical
studies, please include timing of study treatment, dosing, or intervention, start and stop dates of relevant research
interventions:
3. What is the outcome of the event (ex: increased risk or harm to subject or others, violation of subject’s rights, safety,
or welfare, effect on study integrity, change of status of subject in study, etc.)?
2. Describe procedures taken to address problem and the corrective actions to prevent future occurrences, if applicable.
If none, justify:
3. Is a modification needed to the protocol and/or the research consent form to describe this event/problem/risk?
yes
no
If yes, describe and submit a modification.
SECTION III. ADDITIONAL DOCUMENTS
Check this box if additional document(s) are provided and specify the attached documents (ex: de-identified
medical records, Medwatch reports, IND safety reports, DSMB report, information provided by sponsor):
SECTION IV. ATTESTATIONS AND REQUIRED SIGNATURE
PRINCIPAL INVESTIGATOR SIGNATURE:
My signature indicates that I have reviewed and assessed the event(s) described above and the information provided in
this report is accurate and complete.
Principal Investigator (Print/Type)
Signature
Date
THIS BOX FOR OHR IRB USE ONLY!
An unanticipated problem involving risks to subjects or others
Serious non-compliance
None of the above
Chair/IRB Designee: ______________________
OHR TRANS#
Suspension or termination of IRB approval
Continuing non-compliance
Signature:________________________
Promptly Reportable New Information Form (HRP-204)
V.05/7/15
Date: ___ / ___ / ___
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