Checklist EC Dengan Subyek Manusia 2
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SOP 3.4- 010.2013-03 Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine Universitas Gadjah Mada – Dr. Sardjito General Hospital Effective date: 31December 2013 Page 1 of 2 3.4. Use of Study Assessment Forms ANNEX 1 AF 3.4.01-010.2013-03 Page 1 of 6 Study Assessment Form Protocol Number : Date (D/M/Y): Protocol Title : Principal Investigators: License: No: Institute: Contact No. Co – investigator(s): Contact No. Total No. of Participants: No.of Study site: Funding Agency: Contact No. Duration of the Study: Reviewer’s name : Contact No. Type of the Study : Intervention Epidemiology Observation Document based Individual based Genetic Social Survey Others, specify: Review Full Board Expedited
description
ETHICAL CLEARANCE
Transcript of Checklist EC Dengan Subyek Manusia 2
SOP 3.4-010.2013-03
Medical and Health Research Ethics Committee (MHREC)
Faculty of Medicine Universitas Gadjah Mada– Dr. Sardjito General Hospital
Effective date:
31December 2013
Page 1 of 1
3.4. Use of Study Assessment Forms
ANNEX 1 AF 3.4.01-010.2013-03
Page 1 of 6
Study Assessment Form
Protocol Number : Date (D/M/Y):
Protocol Title :
Principal Investigators: License: No:
Institute: Contact No.
Co – investigator(s): Contact No.
Total No. of Participants: No.of Study site:
Funding Agency:Contact No.
Duration of the Study:
Reviewer’s name :Contact No.
Type of the Study : Intervention Epidemiology Observation Document based Individual based Genetic Social Survey Others, specify:
Review Status: Full Board Expedited
Description of the Study in brief: mark whatever applied to the study.
Randomized Stratified Randomized Open-labeled Double blinded Placebo controlled Treatment controlled Cross-over Parallel Interim Analysis Use of Tissue samples Use of Blood samples Use of genetic materials Multicenter study Screening DescriptiveStudy Objectives:…………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………
