SOP 4.4-015.2015-04
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 6 4.4.Review of Final Report
ANNEX 1
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):
SOP 4.4-015.2015-04
Medical and Health Research Ethics Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada – Dr. Sardjito General Hospital
Effective date: 01 August 2015 Page 2 of 6 4.4.Review of Final Report
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:
SOP 4.4-015.2015-04
Medical and Health Research Ethics Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada – Dr. Sardjito General Hospital
Effective date: 01 August 2015 Page 3 of 6 4.4.Review of Final Report
Exempted from review Expedited Review Full Board Review
1. 2. 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
