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SIDCER-FERCAP Survey Form 005: SIDCER Survey Training and Site Visit Agenda E.

Venue and dates for SIDCER-FERCAP training course and survey for Ethics Committees Faculty of Medicine : University-Udayana in Denpasar, and University-Brawijaya in Malang

DENPASAR , 3-6 July 2013 Day 1


08.00-09.00 09.00-09.30 09.30-10.00 10.00-10.45 10.45-11.30 Registration Welcome remark / Opening remark Dean, Faculty of Medicine. Univ- Udayana Coffee break Introduction of EC in Indonesia NHREC Purpose of Surveying and Evaluating Ethical Review Practices Prof. Cristina E. Torres SIDCER Criteria for Evaluating and Surveying Ethics Committees Prof. Cristina E. Torres Lunch The Role of a Surveyor in Evaluating Ethical Review Practices Lead Surveyor: 1. Understanding Procedures in Surveying an EC 2. FERCAP Checklists for the Survey 3.Group Work and Survey Responsibilities Topics

MALANG, 3-6 July 2013 Day 1


Registration Welcome remark /Opening remark Dean, Faculty of Mediine Univ. Brawijaya Coffee break Introduction of EC in Indonesia NHREC Purpose of Surveying and Evaluating Ethical Review Practices FERCAP SIDCER Criteria for Evaluating and Surveying Ethics Committees FERCAP Lunch The Role of a Surveyor in Evaluating Ethical Review Practices Lead Surveyor: 1. Understanding Procedures in Surveying an EC 2. FERCAP Checklists for the Survey 3.Group Work and Survey Responsibilities Topics

11.30-12.30

12.30-13.30 13.30-16.00

1.References, Standards and applicable 1. References, Standards and applicable Guidelines (Local, National, International) Guidelines (Local, National, International) 2.222 2. Evaluation Methodology 2.2222222 2. Evaluation Methodology 3. Definition of Scope, Rationale,Objectives 3. Definition of Scope, Rationale, Objectives 4. Practical tools 4. Practical Tools 5. Reporting and analysis 5. Reporting and Analysis 16.00-16.30 16.30-17.30 17.30 Coffee Break Check and receive documents for survey Departure from the Ethics Committee to the Hotel Coffee Break Check and receive documents for survey Departure from the Ethics Committee for Hotel

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Valid as of: 1 Oct 09

SIDCER-FERCAP Survey Form 005: SIDCER Survey Training and Site Visit Agenda

Day 2
08.00 09.00-09.30 Departure from the Hotel to the Ethics Committee site Overview of EC Profile and Procedures Chair, Faculty of Medicine. University Udayana EC The Survey Plan Lead Surveyor: Coffee Break Visit IRB Office Review of the ECs Legal and Regulatory Framework Discussion with the responsible member and/or staff of the EC of the applicable laws and regulations of the country in which the EC is established Discussion of the national and international guidance documents under which the EC operates Lunch Review of the EC Standard Operating Procedures Examination of the EC Standard Operating Procedures Examination of any documents available to applicants, regulatory authorities, or the authority under which the EC is established Summary of the Days Findings A listing of the strengths of the EC Indications of areas for further consideration Self-evaluation of the days progress by the participants Departure from the Ethics Committee to the Hotel

Day 2
Departure from the Hotel to the Ethics Committee site Overview of EC Profile and Procedures Chair, Faculty of Medicine. University Brawijaya EC The Survey Plan Lead Surveyor: Coffee Break Visit IRB Office Review of the ECs Legal and Regulatory Framework Discussion with the responsible member and/or staff of the EC of the applicable laws and regulations of the country in which the EC is established Discussion of the national and international guidance documents under which the EC operates

09.30-10.00 09.30-10.00 10.00-12.00

12.00-13.00 13.00-14.30

Review of the EC Standard Operating Procedures Examination of the EC Standard Operating Procedures Examination of any documents available to applicants, regulatory authorities, or the authority under which the EC is established Summary of the Days Findings A listing of the strengths of the EC Indications of areas for further consideration Self-evaluation of the days progress by the participants Departure from the Ethics Committee to the Hotel

14.30-17.30

17.30

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Valid as of: 1 Oct 09

SIDCER-FERCAP Survey Form 005: SIDCER Survey Training and Site Visit Agenda

Day 3
08.00 09.00-12.00 Departure from the Hotel to the Ethics Committee site Review of the EC Meeting Conduct Discussion with the responsible member/staff of the EC Review of the agenda and minutes of sample EC meetings Review of the EC Membership Examination of the EC list of members Examination of the EC curriculum vitae Review of Protocols Examination of protocols already reviewed by the EC Lunch Board Meeting Review of Protocols Summary of the days Findings and Survey Observations A listing of findings and observations Departure from the Ethics Committee to the Hotel

Day 3
Departure from the Hotel to the Ethics Committee site Review of the EC Meeting Conduct Discussion with the responsible member/staff of the EC Review of the agenda and minutes of sample EC meetings Review of the EC Membership Examination of the EC list of members Examination of the EC curriculum vitae Review of Protocols Examination of protocols already reviewed by the EC Lunch Board Meeting Review of Protocols Summary of the days Findings and Survey Observations A listing of findings and observations Departure from the Ethics Committee to the Hotel

12.00-13.00 13.00-15.30 15.30-16.30 16.30-18.30

18.30

Day 4 08.00 09.00-12.00 Departure from the Hotel to the Ethics Committee site Interviews; Review of the EC SAE Review and Follow up Procedures: Examination of the EC procedures for receiving and reviewing SAEs Examination of the EC policy and procedures for follow-up review 12.00-13.00 Lunch Summary of findings and observations during the past 3 days list of findings and survey Observations prepared by the surveyors Summary of Findings and Survey Observations Departure from the Hotel to the Ethics Committee site Interviews; Review of the EC SAE Review and Follow up Procedures: Examination of the EC procedures for receiving and reviewing SAEs Examination of the EC policy and procedures for follow-up review Lunch Summary of findings and observations during the past 2 days list of findings and survey Observations prepared by the surveyors Summary of Findings and Survey Observations

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Valid as of: 1 Oct 09

SIDCER-FERCAP Survey Form 005: SIDCER Survey Training and Site Visit Agenda

Page 4 of 4

Valid as of: 1 Oct 09