17. Final Report FKUGM

Medical and Health Research Ethics Committee
(MHREC)
Faculty of Medicine Universitas Gadjah Mada –
Dr. Sardjito General Hospital
SOP 4.4-015.2015-04

Effective date:

4.4.Review of Final Report

01 August 2015
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:

Sponsor’s Name

E-mail address :

Address:
Phone:
Study site(s):
Total Number of study participants :
Number of participants who received the test
articles:
Study materials:

Treatment form:
Study dose(s):
Duration of the study
Objectives:

E-mail :

No. of Study Arms:

Medical and Health Research Ethics Committee
(MHREC)
Faculty of Medicine Universitas Gadjah Mada –
Dr. Sardjito General Hospital
SOP 4.4-015.2015-04

4.4.Review of Final Report

Effective date:
01 August 2015
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.:

TYPE OF REVIEW:

Date:

ASSIGNED REVIEWERS:

Medical and Health Research Ethics Committee
(MHREC)
Faculty of Medicine Universitas Gadjah Mada –
Dr. Sardjito General Hospital
4.4.Review of Final Report

SOP 4.4-015.2015-04

Effective date:
01 August 2015
Page 3 of 6



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
 Resubmission

 Approved with Recommendation
 Disapproved

Signatures:

…………………………
Chairperson
Date

………………………..…
Secretary

Date: