Fillable FormE-IncRep-A DATE APPLICATION

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FormE-IncRep-A DATE APPLICATION

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Page 1 of 4
Document #
This form should be used to report any laboratory accidents, exposures, or noncompliance with
NIH Guidelines and ALL serious adverse events (SAE) that are both related or possibly related to
the use of the human gene transfer product and unanticipated in either nature, severity, or
frequency.
*PLEASE TYPE THIS FORM*
DATE REPORT COMPLETED: IBC Protocol No.
1. PRINCIPAL INVESTIGATOR:
Name (Last, First):
Campus OR Work Phone Number:
Email Address:
2. IBC PROJECT TITLE:
3. Report Involves the following (check all that apply) and answer applicable sections below
Accident Noncompliance with NIH Guidelines
Exposure IBC reportable SAE
Major protocol violation/deviation involving
human rDNA or synthetic nucleic acid transfer use
External reportable event- as determined by
DSMB, DMC or other oversight committee
Any findings from laboratory animal testing that suggest a significant risk for human research
participants including reports of mutagenicity, teratogenicity, or carcinogenicity
4. Description of Accident, Exposure, or SAE
FORM E – Accident/Exposure/
Noncompliance Incident Report
Vers
ion 1.0
Idaho State University, Office for Research
Institutional Biosafety Committee (IBC)
1651 Alvin Ricken Drive, Pocatello, ID 83201-8046
Phone: 208-282-2179 Fax: 208-282-4723
ISU Accident or Exposure Report - Form E/IBC
IBC Protocol No. ________
Version 1.0
Page 2 of 4
Document #
Date of the event
Nature of Agent(s)
involved (Be
specific regarding
rDNA, Infectious
Agent, Toxin)
Nature of Accident
or Exposure
(Describe in Detail)
Location
Personnel Involved
(List all those
potentially
exposed)
Dates of exposure
to human rDNA or
synthetic nucleic
acid transfer
product
Dose at each
exposure
Was this the
dose(s) specified in
the protocol?
Yes No. If no, why?
Who has the
incident be reported
to (Check all that
apply)?
PI IBC TSO IACUC Other
5. If applicable, provide a description of the protocol noncompliance as it relates to NIH Guidelines.
ISU Accident or Exposure Report - Form E/IBC
IBC Protocol No. ________
Version 1.0
Page 3 of 4
Document #
6. If applicable, describe the SAE and its relation or possible relation to the use of the gene transfer
product.
7. If applicable, provide a description of the protocol violation/deviation or noncompliance as it relates to
the human gene transfer use.
8. If applicable, provide a description of the External Reportable Event.
9. If applicable, provide a description of new laboratory findings in animals.
10a. Signature
I have personally reviewed the information contained in the incident report and agree that it is complete and
accurate.
Signature of Principal Investigator
Date
OR
ISU Accident or Exposure Report - Form E/IBC
IBC Protocol No. ________
Version 1.0
Page 4 of 4
Document #
10b. Signature
Form Submitted by
Technical Safety Officer
Office of the Director for Research Integrity
.
Date
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FormE-IncRep-A DATE APPLICATION

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Completed 16 November 2019

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