Medical and Health Research Ethics Committee SOP 3.2-008.

2012-02
(MHREC)
Faculty of Medicine Universitas Gadjah Mada

Effective date:
1 October 2012
Page1 of 5

3.2. Submission of Protocol for Initial

Review

ANNEX 1
AF 3.2.01-008.2012-02
Page 1 of 2
INITIAL REVIEW SUBMISSION FORM
Protocol Title:

Protocol No.:

Total Participants to be included:

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

CHARACTERISTICS of PARTICIPANTS PARTICIPATED:

Age Range:
0 -17 yrs
18 - 44 yrs
Pediatric
None
< 1 yr
Impaired
None
Physically

Vulnerable groups
45 - 65 yrs
1-3 yrs
Cognitively

> 66 yrs
4 -14 yrs
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)
Prosthetics
Gynecological services
Others, specify.
Organ transplantation, specify
.
IONIZING RADIATION USE (X-rays, radioisotopes, etc):
None
Medically indicated only
INVESTIGATIONAL NEW DRUG (IND) / DEVICE (IDE):
None
IND
FDA No.:
Name:.
Sponsor:.
Holder:
BP POM No:.

IDE
FDA No:
Name:
Sponsor:...
Holder:...
BP POM No:

PROCEDURE USE:

Invasive

Non-invasive

MULTI-SITE COLLABORATION:

YES

NO

FINANCIAL DISCLOSURE:

YES

NO

Medical and Health Research Ethics Committee SOP 3.2-008.2012-02

(MHREC)
Faculty of Medicine Universitas Gadjah Mada

Effective date:
1 October 2012
Page2 of 5

3.2. Submission of Protocol for Initial

Review

AF 3.2.01-008.2012-02
Page 2 of 2
INITIAL REVIEW SUBMISSION FORM
PARTICIPATING INVESTIGATORS (add extra pages if necessary):
First / Last Name

License No.

Institution

Telephone / Fax No.

1.
2.
3.
4.
5.

RESEARCH CONTACT
Name:
Institute/Address:
Telephone:
Fax:
E-mail:...
SIGNATURE:
Date: ..
Principal Investigators
TYPE OF INITIAL 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

Medical and Health Research Ethics Committee SOP 3.2-008.2012-02

(MHREC)
Faculty of Medicine Universitas Gadjah Mada

Effective date:
1 October 2012
Page3 of 5

3.2. Submission of Protocol for Initial

Review

ANNEX 2
AF 3.2.02-008.2012-02
Summary Sheet of the Study Protocol
Title of the Protocol*

Principal Investigator (Name, Institution)*

Sponsor

Objectives*

Ethical Issue (s) of the Protocol*

Medical and Health Research Ethics Committee SOP 3.2-008.2012-02

(MHREC)
Faculty of Medicine Universitas Gadjah Mada

Effective date:
1 October 2012
Page4 of 5

3.2. Submission of Protocol for Initial

Review

Type/ Design of the Study (screening, survey, clinical trial, etc.)*

Anticipated Outcome*

Inclusion and Exclusion Criteria*

Withdrawal or discontinuation Criteria

Mode of intervention to the Human/ Animal Subjects*

Analysis (methods)*

Schedule and Duration of Treatment

Medical and Health Research Ethics Committee SOP 3.2-008.2012-02

(MHREC)
Faculty of Medicine Universitas Gadjah Mada

Effective date:
1 October 2012
Page5 of 5

3.2. Submission of Protocol for Initial

Review

Efficacy or Evaluation Criteria (Response/Outcome)

Safety Parameters Criteria (Toxicity)

Activity plan / Timeline*

Abstract* (also in softcopy)

* Please make sure to fill in the field with asterisk

Principle Investigator,
Signature,

____________________________________

______________________

Name

date