Baptist Health – Institutional Review Board
Adverse Event Report – Serious and/or Unexpected Event
(Full Board and Expedited Review)
(Please complete ALL sections of this form. Incomplete forms will be returned)
Principal Investigator:E-mail:
Phone #:
Pager#:
Research Coordinator:
(Name, phone #, email) / IRB #:
Study Title:
- Submit a single .pdf file to . Any pages that require a signature will need to either be submitted via regular mail or scanned and emailed separately.
- All Submissions must be typed.
ALL QUESTIONS MUST BE ANSWERED.
1.Please check one of the following:
□Local event.
□Non-local event.
2.Describe below
a.Patient identification:
b.the serious and unexpected adverse event:
c.action or intervention taken:
d.where care was provided:
e.who is financially responsible for the treatment of this adverse event:
f.dates of occurrence:
3.In the Principal Investigator’s opinion, is the serious and unexpected event:
□Not related to the study, skip to question 5
□Related to the study, go to question 4
□The relationship cannot be ruled out, go to question 4
4.In the Principal Investigator’s opinion, does this serious and unexpected event change the risk/benefit ratio of the study?
□Yes. Please describe:
□No.
5.Has this type of adverse event happened before in connection with this research study?
□Yes. Please describe:
□No.
6.Will this adverse event require changes in the Informed Consent Form or in the research procedures?
□Yes. Please describe:
□No. Why not?
7.Will you notify all other subjects currently enrolled in the research study?
□Yes. Please provide the letter or a summary of your notification and explain the procedures you intend to use to notify all subjects.
NOTE: The IRB may determine that subjects will need to be notified.
□No.
8.Are there steps that can be taken to minimize risk of a similar occurrence in the future?
□Yes. Please describe:
□No.
9.Have you reported this event to the study sponsor?
□Yes
□No.
□Not applicable.
10.Have you reported this event to the Food and Drug Administration (FDA)
□Yes
□No.
□Not applicable.
Please submit any relevant clinical information that is available regarding this adverse event.
Signature of Principal Investigator: ______
Date: ______
Baptist Health – Institutional Review Committee
Adverse Event Reporting Guide
Definitions for Adverse Event Reporting:
A serious adverse event is any adverse event that results in any of the following outcomes:
- Death,
- A life-threatening adverse event,
- Inpatient hospitalization or prolonging existing hospitalization,
- A persistent or significant disability/incapacity or a congenital anomaly/birth defect.
Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, the event may jeopardize the patient or subject and/or may require medical or surgical intervention to prevent one of the outcomes listed in the definition above.
An unexpected adverse event is any adverse event that is:
- Not consistent with the current investigator brochure, protocol, and/or consent form,
- Not part of the normal disease progression,
- Known adverse events occurring more frequently than expected.
The IRB considers all deaths to be Serious and Unexpected, even if it is a possible outcome of disease progression. All deaths on any Expedited or Full Committee study must be reported within five (5) working days, even if the PI considers the death to be unrelated to the study.
A local adverse event is an adverse event that occurs in a subject enrolled in a protocol that is under the supervision of a Baptist Health IRB-approved Principal Investigator. It does not matter where the subject experiences the adverse experience or where the subject may be treated for that adverse experience, the adverse experience is still considered “local”.
CAUSAL RELATIONSHIP OF ADVERSE EVENTS TO STUDY INTERVENTIONS:
A “related” causal relationship between a study intervention and an adverse event exists when the reaction follows within a reasonable time after the administration of the study drug or intervention, follows a known response pattern to the suspected study intervention, and is confirmed by improvement when the study intervention has stopped and the reaction reappears when the intervention is re-administered, or the patient has documented toxic concentrations of the study drug or evidence of the intervention in the blood or other fluid. A “related” causal relationship exists for drug overdoses in a patient with consistent symptoms, exhibits documented toxic concentrations in blood or other fluids, or responds to a specific antidote.
A “cannot be ruled out” causal relationship exists when the reaction follows a known response pattern to the study intervention and is confirmed by improvement when the intervention is stopped, cannot be reasonably explained by the known characteristics of the condition being treated or, when the reaction follows within a reasonable time after the administration of the study drug or intervention, follows a known response pattern to the suspected intervention but could have been caused by the condition being treated by the other interventions.
1.Did this event occur to a subject enrolled (who signed an Informed Consent and/or underwent any study interventions, including tests to determine eligibility) on the protocol that has been approved by the IRB?
□Yes, this event occurred to a subject who participated in the same exact study that has been approved by the IRB. Go to question #2.
□No, this event occurred to a subject enrolled on a different protocol at a different site. The IRB does not require you to submit these events.
□The study sponsor requires that we submit this event to the IRB.
2.Is the adverse event Serious and Unexpected according to IRB definitions? The IRB considers all deaths to be Serious and Unexpected. (Please see page 1 for definitions)
□Yes, Report this event within 5 working days from the time you learned out it to the IRB. Do not proceed further with this form.
□No, This event is not both Serious and Unexpected. Go to question #3.
3.Is the adverse event either Serious or Unexpected according to IRB definitions?
□No, go to question #4.
□Yes, answer question #3a.
a.Did this event occur to a subject enrolled locally?
□Yes, the event occurred to a subject enrolled locally. Please report this event to the IRB at Continuing Review. Do not proceed further with this form.
□No, The event occurred to a subject enrolled at another site. Answer b.
b.Does this study have a DSMB or Sponsor oversight committee?
□No, there is no DSMB/Sponsor oversight committee. Report this event to the IRB at Continuing Review. Do not proceed further on this form.
□Yes, there is a DSMB/Sponsor oversight committee. The IRB does not require you to report this event. The IRB does not require you to submit this event at Continuing Review.
□The study sponsor requires that we submit this event to the IRB.
4.Is the adverse event both Expected and Not Serious?
□No, you do not consider the event to be both Expected and Not Serious. Please reevaluate your classification of the adverse event. All adverse events will fall into one of three categories:
1.Unexpected and Serious,
2.Either Unexpected or Serious, or
3.Expected and Not Serious.
□Yes, this event is both Expected and Not Serious. Answer a.
- Did the event occur to a subject enrolled locally?
□Yes, the event occurred to a subject enrolled locally. Please report this event to the IRB at Continuing Review.
□No, the event occurred to a subject enrolled at another site. The IRC does not require you to report this event.
□The study sponsor requires that we submit this event to the IRB.