Administrative Use Only
Registration Number
Review Date
IBC#
Washington University in St. Louis
Institutional Biological and Chemical Safety Committee (IBC)
Clinical Trial Registration Form
I. Overview
Principal Investigator Name:
Department:
Office Phone:
Alternate Phone:
Email:
Alternate Phone:
Email:
Primary Contact Name:
Department:
Office Phone:
Protocol Title:
Short Title:
myIRB Number:
Principal Investigator Signature
Date
Biological & Chemical Safety Officer
Date
Protocol Submission Type:
New Submission
Updated December 2015
Amendment
Renewal
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II. Study Personnel
Please list the PI, Co-PIs, and all personnel who will be involved in preparation or administration of
the study drug.
Name
Study Role
EH&S Clinic
Safety Training
Date
If any study drug or clinical specimens will be shipped, who is responsible for shipping the items?
Name
Title
EH&S Shipping
Training Date
Who is responsible for submitting reports (annual and safety) to NIH Office of Biotechnology
Activities?
Name
Updated December 2015
Affiliation
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III. Study Facilities
III.A. Study drug preparation
Where will the study drug be prepared?
Building
Room
What personal protective equipment is worn during preparation?
Single gloves
Double gloves
Lab Coat
Disposable lab coat/gown
Eye protection
Respirator (e.g. N95 or PAPR) List type:
Other (list):
What containment equipment (e.g. biosafety cabinet) will be used during preparation?
Equipment type
Certification Date
How will the preparation area be cleaned following preparation?
How will the study drug be transported from the preparation area to the administration area?
III.B. Study drug administration
Where will the study drug be administered?
Building
Room
What personal protective equipment is worn during administration?
Single gloves
Double gloves
Eye protection
Respirator (e.g. N95 or PAPR) List type:
Updated December 2015
Lab Coat
Disposable lab coat/gown
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Other (list):
How long will the recipient remain on site for observation?
Building
Room
Observation Time
How will the administration area be cleaned following preparation?
Updated December 2015
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IV. Study Overview
IV.A Provide a short summary of the purpose and procedures of the study proposed in this
IBC application:
IV.B Specify your research question(s), study aims, or hypotheses:
IV.C Describe the background, significance, and any preliminary studies related to this
project:
V. Use of Live Microorganisms
V.A Will any live microorganisms be administered directly to trial participants?
Microorganism
Route of Administration
Dose
Number of Doses
V.B Is the microorganism attenuated? If so, describe the mechanism of attenuation.
V.C Has the microorganism been inactivated (e.g. irradiated, heat-killed, etc.)? If so, describe
the method of inactivation.
V.D Is there any chance that live microorganisms could be spread from the recipient to close
contacts? If so, what precautions are in place to prevent transmission?
VI. Disposal
Describe how the following items will be discarded:
Item
Sharps
Personal Protective Equipment
Updated December 2015
Disposal Method
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Excess study drug
VII. Emergency Response
VII.A Describe how spills of study drug will be handled (including cleaning and disposal).
VII.B Describe the procedure that will be followed in the event of an occupational exposure
to the study drug.
VIII. Attachments
Please attach copies of the following documents:






Appendix M submission to NIH RAC
NIH RAC response letter
Clinical protocol
Investigator’s brochure
Consent document (preferably on WU template)
Patient discharge instructions (if applicable)
For amendments or renewals, only attach copies of documents that have changed from the
previous submission.
Updated December 2015
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