Komisi Etik – Fakultas Kedokteran
Medical and Health Research Ethics
Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada –
Dr. Sardjito General Hospital
4.2. Review of Protocol Amendments
SOP 4.2-013.2015-04
Effective date:
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
Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada –
Dr. Sardjito General Hospital
4.2. Review of Protocol Amendments
SOP 4.2-013.2015-04
Effective date:
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