IBC Protocol (Clinical Trial)

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:

Primary Contact Name:

Department:

Office Phone:Alternate Phone:Email:

Protocol Title:

Short Title:

myIRB Number:

Principal Investigator Signature / Date
Biological & Chemical Safety Officer / Date

Protocol Submission Type:

New Submission / Amendment / Renewal

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 / Affiliation

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 / Lab Coat / Disposable lab coat/gown
Eye protection / Respirator (e.g. N95 or PAPR) / List type:
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?

IV. Study Overview

IV.AProvide 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 / Disposal Method
Sharps
Personal Protective Equipment
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:

Answers to Appendix M questions in NIH Guidelines

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 May 2016Page 1 of 6