Unanticipated Problem Report
Site:
Protocol #:
Protocol Name:
Submit within 10 days of obtaining new information that indicates a problem that meets all three requirements:
Requirements
How?
A. Increases the risk of harm (physical, psychological, economic or social)
to past, present or future subjects or others (e.g., study personnel,
caregivers or the general public), AND
B. Is unexpected (existence, severity, frequency or circumstances is not
described in the protocol, informed consent form, investigator’s brochure,
label or package insert), AND
C. Is caused by, or related to, the study with a reasonable possibility.
What is/are the new event(s) or information? (Check all that apply)
A serious adverse event, adverse event, adverse device effect, or precursor event
An IND safety report
A laboratory finding
A protocol deviation or violation not pre-approved by the IRB
A change in the protocol without prior IRB approval to eliminate an apparent immediate hazard to a subject
A defect in the study drug or test article
A deficiency in equipment used to collect data relevant to safety monitoring
A complaint from a subject, study personnel, or other person
A change to the test article’s safety profile in the investigator’s brochure, label or package insert
An event that requires reporting to the sponsor
An action or finding by the sponsor
An action or finding by a governmental authority
A breach of subject privacy
Negligence or misconduct by study personnel
Incarceration of a subject (in a study not approved to enroll prisoners)
An injury or potential injury to study personnel, caregiver or other person
New information from the study, such as, a data and safety board interim analysis
New information from an external source, such as a publication, animal study, or other clinical study
Other problem(s):
Describe what happened clearly and concisely:
What is the harm or risk and to whom?
How big is the risk?
Major
Moderate
Minor
If an event, date it occurred:
Did the problem(s) occur at the site?
Yes
No
Both
Date site became aware the problem:
M1002.1 © 2010-2016 MAGI. MAGI members may use this document within their entity and with business partners.
Unanticipated Problem Report
Study subject(s) involved (if any):
Page 2
Subject #s:
Initials:
What actions have been taken to address the risk?
What additional actions will be taken?
What additional actions should be taken?
Do you recommend changes to study documents? If so, where?
Date(s) of event(s):
1st Date:
No
Protocol
2nd Date:
Consent Form
3rd Date:
Has the sponsor been notified?
Yes
No
Date:
If an investigator-initiated trial, has FDA, OHRP or OCR been notified?
Yes
No
Date:
Principal Investigator
Name:
Signature:
Person making report:
Telephone #:
Inv Brochure
Date:
Date of this report:
Email address:
Additional pages are attached to provide full information:
Yes
No
Documentation of the event or new information is attached:
Yes
No
Corrective action plan and status are attached:
Yes
No
Submit form to [IRB address, email, fax #]. For questions about whether a problem qualifies for reporting, contact [name,
email, tel#, fax#].
M1002.1 © 2010-2016 MAGI. MAGI members may use this document within their entity and with business partners.