# Presentation: 763316

## Orientation Guide

**Research and Development**
**VAMC- Houston**

- Modified Date: 01-19-2006

## Adverse Events

** ****It is important to stress reporting of any adverse events. **
** ****With permission of our friends and colleagues at Baylor we have included the following  presentation**

## What is An Adverse Event

- An unanticipated problem that involves risks or potential harm to study subjects.
- Any untoward (serious and unexpected) medical occurrence presenting during treatment or administration with a pharmaceutical product or device that may or may not have a casual relationship with the treatment.

## Types of Adverse Events

**Serious AE’s:**
- Include death, an acute life threatening event (ALTE), a permanently disabling experience, hospitalization that is precipitated by or prolonged by an adverse experience, a congenital anomaly, the development of cancer, a drug overdose, or in the physician’s judgment, an experience that qualifies as such.
**Unexpected AE’s: **
- Are defined as any adverse events that are not identified in nature, severity, or frequency in the investigator’s brochure or described in the research protocol.

## What and When to Report

- All _serious_ events that occur while a subject is enrolled in a clinical research study, or within 30 days of completing a study _at BCM or it’s affiliated hospitals_ must be reported to the IRB.
**SERIOUS AE’S WHETHER EXPECTED OR UNEXPECTED, MUST BE REPORTED EVEN IF THERE IS NO PERCEIVED CONNECTION TO THE RESEARCH.**

## What and When to Report

- All unexpected deaths and ALTE’s, including grade 4 toxicities, whether related or unrelated to the drug or device, must be reported verbally, by fax or email within 48-72 hours.  A report must be submitted via BRAIN within 10 working days.
- All expected serious AE’s, including deaths and ALTE’s must be reported in BRAIN within the same year of occurrence.

## What and When to Report

-  In the absence of chronic underlying disease, the occurrence of a **death** or ALTE in an otherwise healthy individual, whether related to the research or not, should be reported (email) promptly within 48-72 hours by the PI to the IRB.  A report must be submitted via BRAIN within 10 days.
-  All non-serious AE’s may be reported to the IRB at the PI’s discretion.

## What and When to Report

-  All IND reports that the Sponsor has requested to be submitted to the IRB can be sent on a disk/CD or as a hard copy as well as submitting into BRAIN only listing the IND report numbers in “Description.”

## Who Reports AE’s and SAE’s

- Although Coordinators/Administrative staff may report AE’s & SAE’s, the PI is ultimately responsible for the reporting of events that occur at BCM as well as the affiliated hospitals.
- All AE’s and SAE’s must be reported to the BCM IRB @ 713.798.6990 (fax) or _[irb@bcm.tmc.edu](mailto:irb@bcm.tmc.edu)__._
- After reporting AE’s and/or SAE’s, they must be entered into BRAIN and submitted to the Office of Research for review @_[VAAE@bcm.tmc.edu ](mailto:VAAE@bcm.tmc.edu)_

## Other Documentation to Report

-  PI should send any supporting documentation that may be beneficial for the IRB to review.
-  Progress reports are required if the complications of the AE have not been resolved at the time the original report was submitted.
-  For multi-center trials, the PI should forward the DSMB summary report of AE’s to the IRB whenever a review takes place.

## IRB Response to AE’s

**Serious AE’s – BCM:**
- Are promptly reviewed (through BRAIN) by an IRB Chair or Vice-Chair.
-  After review, the Chair or Vice-chair will approve the  AE, or request that modifications be made to the protocol and/or the consent form.  The Chair or Vice-chair may request that enrollment be stopped until a proper plan is developed.
-  All modifications requested will be returned to the PI via BRAIN.

## IRB response to AE’s cont.

- Serious AE’s – Non-BCM:
- Are acknowledged by BRAIN within 24 hours of receipt.
- Non-Serious AE’s – Non-BCM:
- Are acknowledged by BRAIN within 24 hours of receipt.

## Emergency Unexpected AE’s

- If a situation arises in which an unexpected, related SAE occurs and requires an emergent change in the protocol, the following should occur:
-  The PI contacts the IRB to inform of SAE.
- One of the Chair’s communicates with the PI regarding the steps which need to be followed.
-  Enrollment must stop immediately.
-  PI must submit SAE report via BRAIN within 48 hours.

## Emergency Unexpected AE’s

- 	PI must also submit a written report to the IRB Executive  	Committee providing a plan to ensure safety of subjects.
- 	This plan must be reviewed by Dept. Chair for adequacy before submission to the IRB.
- 	Once submitted to IRB plan is reviewed and PI will receive instructions on how to proceed.

## Office of Research/IRB Staff Contact

- Brady Duke		_[bduke@bcm.tmc.edu](mailto:bduke@bcm.tmc.edu)_		713-798-7213
- Bridget Fagbeyiro 	_[fagbeyir@bcm.tmc.edu](mailto:fagbeyir@bcm.tmc.edu)_	             713-798-5308
- Charles Imo		_[cimo@bcm.tmc.edu](mailto:cimo@bcm.tmc.edu)_		713-798-7692
- Miguel Aguirre                _[aguirre@bcm.tmc.edu](mailto:aguirre@bcm.tmc.edu)_    		713-798-2011

## Reporting Adverse Events to The Research and Development Office

## Reporting AE’s to R&D

- Coordinator or PI

- Deaths/ Serious *AEs
- Within  24 hours:
- 1.   Report in BRAIN
- 2. Call Baylor IRB: 713-798-6970 or
- Email @ _[IRB@bcm.tmc.edu](mailto:IRB@bcm.tmc.edu)__ if brain is not working_
- 3. Call VA R&D- for ALL DEATHS
- -Marilyn Crosby RN Phone # 713-794-8096  or Joyce McDaniel phone # 713-794-7564  with protocol number and Adverse Event number/patient initial and last four numbers of SSN
- Email all other Adverse Events
- To : _[VAAE@bcm.tmc.edu](mailto:VAAE@bcm.tmc.edu)_
- 4. Write a note in CPRS

- Other Adverse Events
- 1. Report in Brain within 10  days (med watch, have to be reported within  one year)

- Adverse Event: Death or any medical occurrence that is considered unfavorable or unintended (if in doubt, report it).