DSRB ‘UNANTICIPATED PROBLEMS
INVOLVING RISKS TO SUBJECTS OR OTHERS’
(UPIRTSO) REPORT FORM
OFFICIAL USE ONL Y
Doc Name : DSRB Unanticipated Problems Involving Risks
to Subjects or Others Report Form
Doc Number : 205-012
NHG Domain Specific Review Board (Fax: 6496 6257)
Doc Version : .6.0
Date : 01 Jun 09
Section A: Basic Information
1) DSRB Reference No:
Text Field
2) Protocol Title:
Text Field
3) Principal Investigator:
Text Field
4) Onset Date:
(DD/MMM/YYYY)
Text Field
6) Study Site:
5) Date of First
Knowledge by NHG
Site: (DD/MMM/YYYY)
Local (NHG)
Local (Singapore)
Text Field
Overseas
If ‘Local’, please state which Study Site:_Text Field_
7) Type of Report:
Initial Report
Follow Up report
If ‘Follow Up Report’, state the Initial report date: _Text Field_(DD/MMM/YYYY)
Section B: Does this problem involve a research participant in particular?
No
Yes. If ‘Yes’, please answer the following:-
1) Participant Identifier:
Text Field
3) Gender :
5) Which study arm is
the participant in?
Male
2) Age:
Female
Study Drug
4) Is the participant still in study? :
Comparator
Placebo
Unknown
Text Field
Yes
No
Not applicable
Section C: Does this problem involve an Investigational Product (drug/ device/ biologic/ other agent)?
No
Yes. If ‘Yes’, please answer the following:-
1) Investigational Product Name
Text Field
2) Was the study blind broken?
Yes
No
Not Applicable
3) Is the Investigational Product
registered in Singapore?
Yes
No
Not Applicable
Continued
Discontinued
4) The Investigational Product
was
Not Applicable
Temporarily Stopped
* If ‘Discontinued’ or ‘Temporarily Stopped’, state the stop date:
_Text Field_ (DD/MMM/YYYY)
DSRB Unanticipated Problems Involving Risks to Subjects or Others
Report Form (UPIRTSO), Version 5.0, 01 Jun 2009
Page 1 of 3
Section D: Problem Assessment (Tick all applicable)
Note: Only events that are both Related AND Unexpected are required to be reported (7 calendar days)
Exception: All local deaths regardless of relatedness and expectedness are to be reported (24 hours)
1) Opinion of the NHG PI (for all reports):
Related†
Unexpected‡
2) Opinion of the Sponsor (for sponsored research):
Related†
Unexpected‡
†Related
– Includes possibly related problem. Possibly related means there is a reasonable possibility that the incident, experience, or
outcome may have been caused by the procedures involved in the research.
‡Unexpected - An unexpected problem is one, the nature, severity or frequency is not consistent with information in the study
approved documents and relevant sources of information or the characteristics of the subject population being studied.
Section E: Problem Summary (Please attach additional pages as needed.)
1) Please use keywords, e.g. Liver Failure, Loss of Data, Dispensing Error, etc, to concisely describe the
problem.
Event Keywords: Text Field
2) Describe the problem.
Text Field
3) Is this Event Serious and / or suggests that it places subject or others at a greater risk of harm?
Yes
No
4) Is this Event arising from the protocol stated in Section A, Question 2?
Yes
No
5) Describe the outcome of the problem, including details of what action was taken to resolve the
problem, and if there was any resulting impact on the participant or others.
Text Field
Section F: Additional comments by NHG Principal Investigator
1) Is this problem already listed/described in any of the study
documents? If yes, state where the information can be found
(eg. Participant Information Sheet / IB / Protocol ; Section
X, Page XX etc):
Yes
No
2) Has the study’s risk-benefit ratio changed?
Yes
No
Unable to Assess
3) Has this problem been resolved?
4) Do you recommend changes to protocol and/or informed
consent document? If ‘Yes’, please submit the amendments with the
DSRB Protocol Amendment Cover note.
5) Any other Comments (Please attach additional pages if needed.)
Text Field
Yes
No
Unable to Assess
Yes
No
Unable to Assess
DSRB Unanticipated Problems Involving Risks to Subjects or Others
Report Form (UPIRTSO), Version 5.0, 01 Jun 2009
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Section G: Submission Declaration
I confirm that the information submitted in the above report is true and accurate at the submission
of the report.
___________________________________
Investigator’s Signature
Full Name:
Institution:
Contact Person:
_Text Field_
_Text Field_
_Text Field_
_Text Field_
Date
Study Role:
Department:
Tel:
Email:
Fax:
_Text Field_
_Text Field_
_Text Field_
_Text Field_
_Text Field_
FOR OFFICIAL USE ONLY
Action by DSRB Coordinator:Does this event qualify as reportable event?
Yes
No
Initial & Date: __________________________
Action by DSRB Chair:Not an Unanticipated Problem Involving Risks to Subjects and Others
Table summary at next convened meeting
Table for discussion at next convened meeting
Any other action, please specify
DSRB Unanticipated Problems Involving Risks to Subjects or Others
Report Form (UPIRTSO), Version 5.0, 01 Jun 2009
Initial & Date: _________________________
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This Page is for information only and need not be submitted.
Guidance on Unanticipated Problems Involving Risks to Subjects or Others (UPIRTSO)
Report Form
Administrative Instructions
1. Handwritten UPIRTSO forms will be accepted by the DSRB.
2. However, please ensure that the handwriting is legible. Incomplete forms or illegible
handwritten forms will be rejected.
Reportable Events
The following 2 criteria have to be met for reporting of UPIRTSO.
1. UNEXPECTED
In terms of nature, severity or frequency is not consistent witha. the research procedures that are described in the protocol-related documents, such as the DSRB
approved research protocol and informed consent document; or
b. the characteristics of the subject population being studied.
2. RELATED (including possibly related) to participation in the research
Possibly related means there is a reasonable possibility that the incident, experience, or outcome may
have been caused by the procedures involved in the research.
The following conditions might help to assess causality:
a. the event has a reasonable temporal relationship to the intervention,
b. the event could not have been produced by the underlying disease states,
c. the event could not have been due to other non-study interventions,
d. the event follows a known pattern of response to the intervention, or
e. the event disappears with cessation of intervention.
IMPT: An event need not be SERIOUS to qualify as reportable
Reporting Timeline for Events
1. Urgent Reporting: All problems involving local deaths, whether related or not, should be reported
immediately – within 24 hours after first knowledge by the NHG investigator.
2. Expedited Reporting: All other problems must be reported as soon as possible but not later than 7
calendar days after first knowledge by the NHG investigator.
Health Science Authority (HSA) Reporting requirements
1. For Industry sponsored Trials
 Please continue to report to HSA according to the HSA Guidance for Industry “Safety Reporting
Requirements for Clinical Drug Trials.”
2. For Principal Investigator initiated Trials
 All SAEs that are unexpected and related to the study drug must be reported to HSA.
 The investigator is responsible for informing HSA no later than 15 calendar days after first knowledge that
the case qualifies for expedited reporting. Follow-up information will be actively sought and submitted as
soon as it becomes available.
DSRB Unanticipated Problems Involving Risks to Subjects or Others Reporting
Form (UPIRTSO), Version 5.0, 01 Jun 2009
Page 1 of 3
This Page is for information only and need not be submitted.
 For fatal or life-threatening cases, the PI is responsible for notifying HSA as soon as possible but no later
than 7 calendar days after first knowledge that a case qualifies, followed by a complete report within 8
additional calendar days."
Completion Guidelines
Section A: Basic Information
1) DSRB Reference No – Please state the DSRB reference number as stated in the approval letter.
2) Protocol Title – Please state the DSRB Approved Protocol Title.
3) Principal Investigator – Please state the name of the NHG PI.
4) Onset Date – Please state the date the problem (event) occurred.
5) Date of First Knowledge by NHG Site – Please state the date the NHG site first became aware of the
problem (event).
6) Study Site – Please check the relevant box. Local (Singapore) refers to events that had occurred at sites
outside of NHG, e.g., SingHealth sites who are also participating in the same trial.
7) Type of Report – Please check the relevant box. Please state the date of the associated Initial report if
you are reporting a Follow-up.
Section B: Does this problem involve a research participant in particular?
If the problem involves a research participant, please provide details as required. If the problem does not
involve a specific participant, please provide details in Section E – Problem Summary.
Section C: Does this problem involve an Investigational Product (drug / device / biologic / other agent)?
If the problem involves an Investigational Product, including drug, device, biologic or other agent, please
provide details as required. If the action taken with the Investigational Product was discontinued or
temporarily stopped, please provide the stop date.
Section D: Events Assessment
For all events, you are only required to report RELATED and UNEXPECTED events. Events that do not
fulfil this criterion, e.g., related and expected events, or unrelated and unexpected, or expected events, do not
need to be reported.
For all local deaths, you must report the event, regardless of relatedness and unexpectedness
Section E: Problem Summary
1) Please use keywords, e.g. Liver Failure, Loss of Data, Dispensing Error, etc, to concisely describe
the problem.
2) Describe the problem. Please attach additional pages as needed.
3) Is this Event Serious and / or suggests that it places subject or others at a greater risk of harm?
a. For Adverse Events (i.e. studies involving drug / device / biologic / other agent) an event is
considered serious if the event:
 results in death,
 is life-threatening,
 requires inpatient hospitalization or prolongation of existing hospitalization,
 results in persistent or significant disability/incapacity, or
 is a congenital anomaly/birth defect
4) Please indicate if the event reported arises in the same study protocol stated in Section A. For
events occurring in other studies (eg. studies investigating on same study drug but different
indication/dose/subject population), please indicate ‘No’ for this question.
5) Describe the outcome of the problem, including details of what action was taken to resolve the
problem, and if there was any resulting impact on the participant or others. Please attach additional
pages as needed.
DSRB Unanticipated Problems Involving Risks to Subjects or Others Reporting
Form (UPIRTSO), Version 5.0, 01 Jun 2009
Page 2 of 3
This Page is for information only and need not be submitted.
Section F: Additional comments by NHG Principal Investigator
Does the reported problem (event) alter the study’s risk-benefit ratio? If yes, to comment if there is a
need to make changes to study protocol and/or informed consent document. Please also indicate if the
reported problem (event) has been listed/described in any study documents.
Note: Completion Guidelines for Reporting of CIOMS I Form or MedWatch 3500 Form
a) If you are reporting a single problem (event) that is applicable for multiple studies, please submit the
following items:(i) One UPIRTSO Report form
(ii) UPIRTSO Report Annex A – Multiple Studies Reporting
(iii) One associated CIOMS I/MedWatch 3500 form
b) For all overseas events, including overseas deaths, you are only required to report RELATED and
UNEXPECTED events. If there is an overseas death that is unrelated or expected, there is no need to
report this event to the DSRB. Reporting timelines for overseas events are 7 calendar days from the NHG
investigator’s knowledge of the event.
DSRB Unanticipated Problems Involving Risks to Subjects or Others Reporting
Form (UPIRTSO), Version 5.0, 01 Jun 2009
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