Institutional review board irb modification request



Download 37.31 Kb.
Date13.12.2016
Size37.31 Kb.
THE UNIVERSITY OF TEXAS AT TYLER

INSTITUTIONAL REVIEW BOARD
IRB MODIFICATION REQUEST

IRB: Click here to enter text.


Approved by: Click here to enter text.

Date: Click here to enter text.


Date: Click here to enter text.

Principal Investigator: Click here to enter text.
Department: Click here to enter text.
IRB #: Click here to enter text.
Project Title: Click here to enter text.
Original Approval Date: Click here to enter text.
Please complete all sections as appropriate and submit to the UT Tyler IRB Chair.
IDENTIFICATION OF CHANGE(S)
A. GENERAL
☐Change in Title of Protocol

☐Resubmission to Grant/Contract Agency

☐Change in Extramural Sponsor

☐Change in Cooperating Institution

☐Change in Status of Protocol (e.g., from "active" to "hold")
Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.

B. DESIGN
☐Change in Study Design
Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.

C. PERSONNEL
☐Change in investigators, faculty or staff:
Name: Click here to enter text.

Credentials: Click here to enter text.

Contact Information: Click here to enter text.
☐Change in Consultant/Collaborator
Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.


D. RISK

☐Change In Risk/Benefit Ratio (e.g., emergence of new side effects)


Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.


E. COST
☐Change in Subject Expense

☐Change in Subject Reimbursement


Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.


F. PROCEDURES INVOLVING SUBJECTS
☐Change in collection of blood or other body fluids

☐Change in subject evaluation (e.g., number of visits, etc.)

☐Change in administration or dosage of drug

☐Change in drug formulation

☐Change/Deletion of any test

☐Change/deletion of device


Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.

G. STUDY POPULATION
☐Change in sample size

☐Change in eligibility criteria

☐Change in exclusion criteria

☐Alteration of study groups

☐Other: Click here to enter text.
Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.


H. SUBJECT RECRUITMENT
☐Change in recruitment procedures

☐Change in ads, flyers, etc.

Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.

I. OTHER
☐Any other significant changes
Explain any related changes: Click here to enter text.
Explain rationale for changes: Click here to enter text.

EXPLANATION OF CONSEQUENCES OF CHANGES
J. Modifications identified above require changes in:
☐Informed consent form (describe by highlighting or tracking of originally approved form)

K. Will these changes result in a change of the risk/benefit ratio?
Yes No
If Yes, please explain: Click here to enter text.


ELECTRONIC ENCLOSURES AS NEEDED FOR CHANGES INDICATED:
☐Revised Informed Consent Form(s)

☐Letter from Sponsor

☐Letter from Investigators indicating their removal or addition to study

☐Revised Protocol (Date of Revised Protocol: Click here to enter text. )

☐Revised IRB Full Board Review Application

☐Revised Investigator's Brochure

☐Other: Click here to enter text.


SIGNATURE OF PRINCIPAL INVESTIGATOR




Click here to enter text. Click here to enter text.

Principal Investigator Signature Date

(Electronic submission of this

form by PI indicates signature)




UT Tyler IRB Modification Request

Approved 3-10-05; Revised 0106; 0207; 0507; 0408; 0209; 0910; 10-11-11; 03-26-12






Share with your friends:


The database is protected by copyright ©dentisty.org 2019
send message

    Main page