IRB - Serious and/or Unexpected Adverse Event (S)AE) Reporting Form

Driscoll Children’s Hospital (DCH) Institutional Review Board (IRB)

Adverse Event(AE) /Unanticipated Problem(UP) Reporting Form

A. IRB Reporting Information	F. Severity
1. Date of This Report: mm/dd/yy _____________________________________ 2. Date of Event: mm/dd/yy _____________________________________ 3. Protocol Title: _______________________ 4. DCH IRB/Protocol #: 5. Principal Investigator: Co-Investigator: Study Coordinator:	1. Severity of Event: (Select only one) Mild Moderate Severe Life Threatening Fatal Comments:
	G. Suspect Medication(s)
	1. Name & Manufacturer:______________________________ ___________________________________________________ 2. Dose/Frequency/Route:_______________________________ __________________________________________________ 3. Therapy Dates/Duration:______________________________________ ____________________________________________________
6. Sponsor(s):	4. Resolved: without sequelae with sequelae ongoing Date of resolution:_____________________________________
7. Name of Person Reporting (S)AE/UP: Phone/Email/Fax: Health Professional? Yes No Occupation:___________________________ 8. Also reported to: Manufacturer User Facility Distributor FDA OHRP Comments:	5. Diagnosis:_________________________________________ 6. Lot#:______________________________________________ 7. Exp. Date:____________________________ 8. Is adverse event related to the study drug/medical device/study procedure? unrelated unlikely possible probable definite not applicable 9. Date of event resolution:
B. Patient/Subject Information	H. Medical Device
1. Patient Identifier: 2. Date of Birth: 3. Sex: Male Female 4. Weight: ______ lbs. or ______kgs.	1.Brand Name/Type of Device: 2. Describe device adverse event:
C. Adverse Event or Product Problem
Adverse Event: and or Product Problem:
D. Adverse Event/Unanticipated Problem Outcome (check all that apply)
Death Life-Threatening Hospitalization Disability Intervention Required If deceased mm/dd/yy:
E. Adverse Event or Unanticipated Problem
1.Description of Event or Problem:
2. Relevant Lab Tests/Data/Dates:
3. Relevant History, Preexisting Medical Conditions:
4. Does this require a protocol change/modification? Yes No Does this require a change/modification in the consent document Yes No Is re-consent necessary? Yes No (If a change/modification is needed, attach a copy of the revised consent document with the changes highlighted and submit a second copy of the revised version unmarked for IRB stamp of approval.)
5. Signature of person filing out form:___________________________________________________________ SIGNATURE OF INVESTIGATOR:______________________________________________________________ (signatures must be legible)
NOTICE: An event report must be turned in within 3-14 days of the event depending on severity, with a copy to Jucel Nazareno, RN, IRB Monitor at ph:361-694-4619, fax: 361-694-5466 or Email: Juleros.Nazareno@dchstx.org in the Driscoll Children’s Hospital Institutional Review Board (DCH IRB) office. The IRB Office is on the third floor of the main building next to the Medical Library.