Medical and Health Research Ethics

Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada
– Dr. Sardjito General Hospital

4.2. Review of Protocol Amendments Effective date:

SOP 4.2-013.2015-
04 01 August 2015
Page 1 of 1

ANNEX 1
AF 4.2.01-013.2015-04

Protocol Amendment Submission Form

PROTOCOL NUMBER: APPROVED DATE:

PROTOCOL TITLE:
PRINCIPAL INVESTIGATOR:

INSTITUTE: Telephone:

SUBMITTED DATE of AMENDMENT: AMENDMENT NO.

REQUEST FOR AMENDMENT MEMORANDUM (use additional page if necessary):

- State/describe the amendment
- Provide the reason for the amendment
- State any untoward effects with original protocol
- State expected untoward effects because of the amendment
Note: Changes made to the protocol and protocol-related documents should be clearly marked either
with the underlining or highlighting feature of the software package used to prepare the document.

SIGNATURES:

Date:……………..
Principal Investigator
TYPE OF REVIEW: ASSIGNED REVIEWERS:

 Exempted from review 1.

 Expedited Review 2.
 Full Board Review
3.

Reviewer for informed consent

documents:

COMPLETION:

Date:…………………
Secretary of MHREC-FM UGM