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Medical and Health Research Ethics

Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada

Dr. Sardjito General Hospital
Effective date:
SOP 4.4-015.2015-
4.4.Review of Final Report 01 August 2015
04
Page 1 of 6

ANNEX 1
AF 4.4.01-015.2015-04
page 1 of 2
Study Report Form

Protocol No.:
Protocol Title:

Principal Investigator:

Phone number: E-mail address :


Sponsor’s Name

Address:

Phone: E-mail :
Study site(s):

Total Number of study participants : No. of Study Arms:

Number of participants who received the test


articles:

Study materials:

Treatment form:

Study dose(s):

Duration of the study


Objectives:
Medical and Health Research Ethics
Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada

Dr. Sardjito General Hospital
Effective date:
SOP 4.4-015.2015-
4.4.Review of Final Report 01 August 2015
04
Page 2 of 6

ANNEX 1
AF 4.4.01-015.2015-04
page 2 of 2

Results:
(Use extra blank paper,
if more space is
required.)

Signature of P.I.: Date:


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

Dr. Sardjito General Hospital
Effective date:
SOP 4.4-015.2015-
4.4.Review of Final Report 01 August 2015
04
Page 3 of 6

TYPE OF REVIEW: ASSIGNED REVIEWERS:

 Exempted from review 1.

 Expedited Review 2.
 Full Board Review
3.

COMPLETION:

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

MHREC FM UGM - Dr. Sardjito General Hospital Comments:

MHREC FM UGM - Dr. Sardjito General Hospital Decision:


 Approved  Approved with Recommendation
 Resubmission  Disapproved

Signatures:

………………………… ………………………..…
Chairperson Secretary
Date Date:

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