Amendment form Rev 1.docx

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Workstation : IREC Version No. : 01 Revision : 01

Effective Date : 21.04.2016

AMENDMENT FORM

• Amendments or changes to an approved research protocol must be reported promptly to the IREC as these changes cannot be initiated without IREC approval. The only exception being to eliminate apparent immediate hazards to the subject.

• Protocol and the informed consent form must be consistent with each other, if there is an

amendment or modification to the protocol that affects the informed consent form, there must be an analogous amendment or modification to the informed consent form.

• The Principal Investigator (PI) must submit a copy of the protocol amendments, or any other study related amendments together with Amendment Form (Appendix 19) to the IREC Secretariat.

• Any major changes on the study must get Kulliyyah Research Committee/Institution Approval first prior submitting amendment to IREC

• The PI will highlight the modification(s) in the amendment, along with a summary of the changes.

 Please email the pdf version of this form to [email protected] IREC No:

Protocol Title:

Principal Researcher:

What changes have occurred or are intended?

(These could include changes in procedure or direction of the project, changes in the source or manner of recruitment, or changes in the number of participants)

Versions and dates

Please list the name, version number and date of every document you would like reviewed.

NB: If the document is not attached to your email and not listed here, it will not appear on your approval certificate.

e.g. Protocol Version 2, dated 13-Nov-2011

Please explain the reason/s for these changes

Do you believe these changes raise any ethical issues?

Yes No

If Yes, please identify any ethical issues:

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Have you attached the most recent document with all changes tracked or highlighted, including other documents if relevant, to which these amendments refer, and/or summaries of changes to the

protocol/proposals?

Yes No

Do you believe the Participant Information and Consent Forms needs to be changed?

Yes No

If Yes, have you attached an amended version with all changes tracked or highlighted?

Yes No List of amended documents

Principal Researcher or Project contact person Name:

Phone:

Email for correspondence:

Principal Researcher’s Signature: Date:

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RECOMMENDATIONS (for IREC use only) Document Date

Comments of Primary Reviewer

RECOMMENDED ACTION:

 Approve

 Minor Modification to The Study Protocol , Subject to Expedited Review at the Level of the Panel Chair

 Major Modification to the Study Protocol, Subject to Full Panel Review

 Disapprove

 Pending, If Major Clarifications are Required Before a Decision can be Made

PRIMARY REVIEWER Signature

Date: Name :

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