Download Unanticipated Problem Involving Risk to Subject or Others

UNANTICIPATED PROBLEM INVOLVING RISK TO SUBJECTS OR OTHERS
REPORT FORM
This form is to be used to report any issues that are related to the safety, rights and welfare of study
subjects. Please complete this form and submit within 10 calendar days from the date of discovery.
This includes the reporting of AEs, SAEs, UAEs, SUSARs, Protocol Deviations/Violation, which includes
Drug or Device.
PART A
Unanticipated/Unexpected:
YES
This event has not been previously mentioned in the IB, Safety Letters, ICF or
protocol, or is the frequency and/or severity more than initially documented or
expected?
Increased Risk:
YES
Does this event increase the risk to the study subject or others?
Study Drug/Device or Study Related:
YES
Is this event related to the study product and/or study participation (including
wash-out periods)? Is there evidence the event was caused by the study product
and/or study participation (other than just occurring while on study)?
If you have answered YES to ALL of the above questions, please continue to PART
B of this form.
If you have not answered YES to ALL of the above questions
, this event does
not require reporting to Aspire. However, this does not mean this event does not
require reporting to the CRO/Sponsor.
Federal Regulation 21 CFR 56.108(b)(1), 21 CFR 812. and 45 CFR 46.103(b)(5) require IRBs to “follow written
procedures for ensuring prompt reporting to the IRB…any unanticipated problems involving risks to human
subjects or others...”
Page 1 of 4
Version date: May 1, 2013
PART B
UNANTICIPATED PROBLEM INVOLVING RISK TO SUBJECTS OR OTHERS
This form is to include the reporting of events that affect the safety, rights and welfare
of study subjects
All reports to the IRB should explain clearly why the event / problem is "unanticipated" and why
the event represents a “problem involves increased risk(s) to the subject or others.”
NAME OF PRINCIPAL INVESTIGATOR:
SPONSOR NAME:
PROTOCOL NUMBER:
STUDY DRUG/DEVICE:
SUBJECT ID:
DATE OF REPORT:
DATE OF OCCURRENCE:
DID THIS INCIDENT HAPPEN TO A STUDY SUBJECT WHILE ENROLLED AT YOUR
SITE?
YES
NO
HAS THIS INCIDENT BEEN REPORTED TO THE FDA?
YES
NO
HAS THIS INCIDENT BEEN REPORTED TO THE SPONSOR?
YES
NO
Describe Unanticipated/Unexpected Event/Problem (include relevant dates)
Federal Regulation 21 CFR 56.108(b)(1), 21 CFR 812. and 45 CFR 46.103(b)(5) require IRBs to “follow written
procedures for ensuring prompt reporting to the IRB…any unanticipated problems involving risks to human
subjects or others...”
Page 2 of 4
Version date: May 1, 2013
Treatment / Outcome (include relevant dates):
Pertinent subject history (if applicable):
Why do you consider the incident “Unanticipated/Unexpected”?
How does this event suggest that subjects or others are at greater risk of harm
than was previously known? **
** Please note: Reports of unanticipated problems to Aspire should include a corrective action
plan for the issue, or an explanation for why none is provided.
Federal Regulation 21 CFR 56.108(b)(1), 21 CFR 812. and 45 CFR 46.103(b)(5) require IRBs to “follow written
procedures for ensuring prompt reporting to the IRB…any unanticipated problems involving risks to human
subjects or others...”
Page 3 of 4
Version date: May 1, 2013
What actions will be taken with the study in response to this problem? (Please
note that an Unanticipated Problem typically requires at least one of the
following.):
Change in the conduct of the study (amendment, suspension of enrollment,
etc). Please specify:
Revision of the Informed Consent document
Other action:
Printed Name of Person Completing Form
Phone number
Company/Title
Fax number
E-mail
Federal Regulation 21 CFR 56.108(b)(1), 21 CFR 812. and 45 CFR 46.103(b)(5) require IRBs to “follow written
procedures for ensuring prompt reporting to the IRB…any unanticipated problems involving risks to human
subjects or others...”
Page 4 of 4
Version date: May 1, 2013