Agenda Training and Survey_UNUD_UNBRAW_3-6 July 2013-1.pdf

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

Page 1 of 4 Valid as of: 1 Oct 09

E. Venue and dates for SIDCER-FERCAP training course and surveyfor Ethics Committees Faculty of Medicine : University-Udayana inDenpasar, and University-Brawijaya in Malang

DENPASAR , 3-6 July 2013 MALANG, 3-6 July 2013

Day 1 Day 1

08.00-09.00 Registration Registration

09.00-09.30 Welcome remark / Opening remark

Dean, Faculty of Medicine. Univ- Udayana

Welcome remark /Opening remark

Dean, Faculty of Mediine Univ. Brawijaya

09.30-10.00 Coffee break Coffee break

10.00-10.45 Introduction of EC in Indonesia

NHREC

Introduction of EC in Indonesia

NHREC

10.45-11.30 Purpose of Surveying and Evaluating

Ethical Review PracticesProf. Cristina E. Torres

Purpose of Surveying and Evaluating

Ethical Review Practices

FERCAP

11.30-12.30 SIDCER Criteria for Evaluating and

Surveying Ethics Committees

Prof. Cristina E. Torres

SIDCER Criteria for Evaluating and

Surveying Ethics Committees

FERCAP

12.30-13.30 Lunch Lunch

13.30-16.00 The Role of a Surveyor in Evaluating


Lead Surveyor:

1. Understanding Procedures in Surveying

an EC

2. FERCAP Checklists for the Survey

3.Group Work and Survey Responsibilities

Topics

1.References, Standards and applicable

Guidelines (Local, National, International)

2. Evaluation Methodology

3. Definition of Scope, Rationale,Objectives

4. Practical tools

5. Reporting and analysis

The Role of a Surveyor in Evaluating


Lead Surveyor:

1. Understanding Procedures in Surveying

an EC

2. FERCAP Checklists for the Survey

3.Group Work and Survey Responsibilities

Topics

1. References, Standards and applicable

Guidelines (Local, National, International)

2. Evaluation Methodology

3. Definition of Scope, Rationale, Objectives

4. Practical Tools

5. Reporting and Analysis

16.00-16.30 Coffee Break Coffee Break

16.30-17.30 Check and receive documents for survey Check and receive documents for survey

17.30 Departure from the Ethics Committee

to the Hotel

Departure from the Ethics Committee

for Hotel


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Day 2 Day 2

08.00 Departure from the Hotel to the Ethics

Committee site

Departure from the Hotel to the Ethics

Committee site

09.00-09.30 Overview of EC Profile and Procedures

Chair, Faculty of Medicine. University

Udayana EC

Overview of EC Profile and Procedures

Chair, Faculty of Medicine. University

Brawijaya EC

09.30-10.00 The Survey Plan

Lead Surveyor:

The Survey Plan

Lead Surveyor:

09.30-10.00 Coffee Break Coffee Break

10.00-12.00 Visit IRB Office

Review of the ECs Legal and Regulatory

Framework

Discussion with the responsible memberand/or staff of the EC of the applicable

laws and regulations of the country in

which the EC is established

Discussion of the national andinternational guidance documents under

which the EC operates

Visit IRB Office

Review of the ECs Legal and Regulatory

Framework

Discussion with the responsible memberand/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 internationalguidance documents under which the EC

operates

12.00-13.00 Lunch

13.00-14.30 Review of the EC Standard Operating

Procedures

Examination of the EC StandardOperating Procedures

Examination of any documents availableto applicants, regulatory authorities, orthe authority under which the EC is

established

Review of the EC Standard Operating

Procedures

Examination of the EC Standard OperatingProcedures

Examination of any documents available toapplicants, regulatory authorities, or theauthority under which the EC is established

14.30-17.30 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 bythe participants

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 theparticipants

17.30 Departure from the Ethics Committeeto the Hotel

Departure from the Ethics Committeeto the Hotel


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Day 3 Day 3


Committee site


Committee site

09.00-12.00 Review of the EC Meeting Conduct

Discussion with the responsiblemember/staff of the EC

Review of the agenda and minutes ofsample 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

Review of the EC Meeting Conduct

Discussion with the responsiblemember/staff of the EC

Review of the agenda and minutes ofsample 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


13.00-15.30 Board Meeting Board Meeting

15.30-16.30 Review of Protocols Review of Protocols

16.30-18.30 Summary of the days Findings and Survey

Observations

A listing of findings and observationsSummary of the days Findings and Survey

Observations

A listing of findings and observations

18.30 Departure from the Ethics Committee

to the Hotel

Departure from the Ethics Committee

to the Hotel

Day 4


Committee site


Committee site

09.00-12.00 Interviews;

Review of the EC SAE Review and Follow up

Procedures:

Examination of the EC procedures forreceiving and reviewing SAEs

Examination of the EC policy andprocedures for follow-up review

Interviews;

Review of the EC SAE Review and Follow up

Procedures:

Examination of the EC procedures forreceiving and reviewing SAEs

Examination of the EC policy andprocedures for follow-up review


Summary of findings and observations during

the past 3 days

list of findings and survey Observationsprepared by the surveyors

Summary of Findings and SurveyObservations

Summary of findings and observations during

the past 2 days

list of findings and survey Observationsprepared by the surveyors

Summary of Findings and SurveyObservations


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Agenda Training and Survey_UNUD_UNBRAW_3-6 July 2013-1.pdf

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