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Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2.

Review of Protocol Amendments

SOP 4.2013.2011-01 Effective date: 1 July 2011 Page 1 of 7

ANNEX 1 AF 4.2.01-013.2011-01 Protocol Amendment Submission Form


PROTOCOL NUMBER: PROTOCOL TITLE: APPROVED DATE:

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

Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2. Review of Protocol Amendments

SOP 4.2013.2011-01 Effective date: 1 July 2011 Page 2 of 7

Decision for Review type: EXPEDITED (Minor changes) FULL REVIEWED Date : ... Secretary, MHREC FM UGM

ANNEX 2 AF 3.2.02-008.2011-01 Summary Sheet of the Study Protocol Title of the Protocol*

Principal Investigator (Name, Institution)*

Sponsor

Abstract*

Type of Protocol (screening, survey, clinical trial, etc.)*

Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2. Review of Protocol Amendments

SOP 4.2013.2011-01 Effective date: 1 July 2011 Page 3 of 7

Objectives*

Anticipated Outcome*

Inclusion and Exclusion Criteria*

Withdrawal or discontinuation Criteria

Mode of intervention to the Human/ Animal Subjects*

Methodology (synopsis of study design)*

Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2. Review of Protocol Amendments

SOP 4.2013.2011-01 Effective date: 1 July 2011 Page 4 of 7

Analysis (methods)*

Activity plan / Timeline*

Schedule and Duration of Treatment

Efficacy or Evaluation Criteria (Response/Outcome)

Safety Parameters Criteria (Toxicity)

* Please make sure to fill in the field with asterisk Principle Investigator, Signature,

Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2. Review of Protocol Amendments

SOP 4.2013.2011-01 Effective date: 1 July 2011 Page 5 of 7

____________________________________ ______________________ Name date

ANNEX 1 AF 3.2.01-008.2011-01 Page 1 of 2 INITIAL REVIEW SUBMISSION FORM


Protocol Title:

Protocol No.: included:

Total Participants to be

STUDY TYPE: (Mark whichever apply to the study) Survey Social Medical Community based Individual based Screening Observational Epidemiology Intervention study Clinical Trial: Phase I Phase II Phase III Phase IV Genetic Study Retrospective Prospective Others STUDY POPULATION: Healthy Patient Vulnerable groups CHARACTERISTICS of PARTICIPANTS PARTICIPATED: Age Range: 0 -17 yrs 18 - 44 yrs 45 - 65 yrs > 66 yrs Pediatric None < 1 yr 1-3 yrs 4 -14 yrs Impaired None Physically Cognitively Mentally REQUESTED EXCLUSION OF PARTICIPANTS: None Male Female Children Other (specify):

SPECIAL RESOURCE REQUIREMENTS (check all that apply): Intensive Care Isolation unit Surgery Pediatric Intensive Care Transfusion CAT scan Gene therapy Controlled substances (Narcotics/ Psychotropics)

Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2. Review of Protocol Amendments

SOP 4.2013.2011-01 Effective date: 1 July 2011 Page 6 of 7

Prosthetics Gynecological services specify. Organ transplantation, specify . IONIZING RADIATION USE (X-rays, radioisotopes, etc): None Medically indicated only INVESTIGATIONAL NEW DRUG (IND) / DEVICE None IND FDA No.: Name:. Sponsor:. Holder: BP POM No: . PROCEDURE USE: Invasive YES YES (IDE):

Others,

IDE FDA No: Name: Sponsor:... Holder:... BP POM No: Non-invasive NO NO

MULTI-SITE COLLABORATION: FINANCIAL DISCLOSURE:

AF 3.2.01-008.2011-01 Page 2 of 2 INITIAL REVIEW SUBMISSION FORM


PARTICIPATING INVESTIGATORS (add extra pages if necessary): First / Last Name 1. 2. 3. 4. 5. License No. Institution Telephone / Fax No.

RESEARCH CONTACT Name: Institute/Address:

Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada 4.2. Review of Protocol Amendments

SOP 4.2013.2011-01 Effective date: 1 July 2011 Page 7 of 7

Telephone: Fax: E-mail:... SIGNATURE: Date: .. Principal Investigators TYPE OF INITIAL REVIEW: Exempted from review Expedited Review Full Board Review Emergency Review COMPLETION: Date: Secretary of MHREC-FM UGM ASSIGNED REVIEWERS: 1. 2. 3.