SOP 4.2-013.2015-04
Medical and Health Research Ethics
Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada –
Dr. Sardjito General Hospital
Effective date: 01 August 2015 Page 1 of 1
4.2. Review of Protocol Amendments
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 Expedited Review Full Board Review
1. 2. 3.
Reviewer for informed consent documents:
COMPLETION:
