TOWARD EXCELLENCE

Goal Thailand is one among many countries conducting sponsored clinical trials

Key success factor

Efficient Ethics Committees

Quality of review

Turn around time (speed)

MODEL 1-RECOGNIZED EC/FDA

FDA

EC1

EC2

EC3

EC4

EC5

EC6

(For EC in FDA’s list)

MODEL 2- REGIONAL JOINT EC

•Recognized EC in

each region takes

responsibility, or

•Establishing new

regional joint EC

MODEL 3-CENTRAL

CEC

www.crecthai.org

EC/IRB PROFILE AND

OVERVIEW OF EC/IRB

PROCEDURES

APHORNPIROM KETUPANYA.M.D.

MARCH 12,2005

HISTORY

How to reduce time of review for multicenter clinical

trials so that the study can be initiated as early as

possible?

Joint Research Ethics Committee (JREC) was established

in 2007

Supported by

JREC, however, is not in Thai FDA list.

( NRCT )

The National Research Council of Thailand adopt

its new policy.

from sponsor’s role to research ethics and

quality oversight.

In 2010, create a new program to promote

ethical standards of research involving

human.

THE CENTRAL RESEARCH ETHICS COMMITTEE

Established on January 2013 under a support from the Foundation of Human Research Promotion in Thailand(HRTP) to solve the slow progress, repetitive and inconvenient for multi-center clinical researches.

Protocol submission to CEREC is a one-stop process whereby CEREC opinion is accepted by the written MOU from Ethics committees of 24 Institutions

Only Multicenter Study (either clinical or health related

social study)

NEW SCOPE FOR PROTOCOL SUBMISSION

• โครงการวจยทเปนพหสถาบน (multicenter study)

• โครงการวจยของสถาบนทไดรบทนสนบสนนจากหนวยงานกลางของรฐบาล เชน ส านกงานคณะกรรมการวจยแหงชาต (วช.) ส านกงานกองทนสนบสนนการสรางเสรมสขภาพ (สสส.) สถาบนวจยระบบสาธารณสข (สวรส.) เปนตน(Sponsor by government

agency)

• โครงการวจยของสถาบนหรอหนวยงานทไมมคณะกรรมการจรยธรรมการวจยของสถาบน ( The research institute that no EC.)

คณะกรรมการ CREC มงสรางใหเกดความเชอมนในระบบการพจารณาโครงรางการวจย 4 ประการ ดงน

• การพจารณาอยางเปนอสระ (Independent review):

• มสมรรถนะ (Competence):

• มคณภาพ (High quality):

• ตามก าหนดเวลา (In time)

No. Rank Name Surname Position Qualification

1. Maj.Gen. Aphornpirom Ketupanya Chair M.D., MSc. (Clinical epidemiology)

OB-GYN, Maternal and Fetal Medicine,

Prenatal Genetics.

2. Assoc.Prof. Pornthep Chanthavanich Vice Chair M.D., Pediatrics, Infectious Diseases, Family

Medicine, Tropical Medicine, Prevention Medicine.

3. Col. Sangkae Chamnanvanakij Member M.D., Pediatrics, Neonatologist, , Family Medicine,

M.Sc. Clinical Epidemiology,WIRB Fellow

4. Assoc.Prof. Waipoj Chanvimalueng Member M.D.,Otolaryngology, Family Medicine, Facial

Plastic and Reconstructive Surgery

5. Assoc.Prof. Jinda Wangboonskul Member PhD., MSc.(Pharm. Chem), B.Pharm.

6. Miss Jareewan Thienjeen Member LL.B (Bachelor of Laws) , Master of Laws , Thai

Barister

7. Col. Suthee Panichkul Secretary M.D.,OB-

GYN,FamilyMedicine,M.Sc.ClinicalEpidemiology,WI

RB Fellow

8. Miss Budsaba Wiriyasirivaj Asst.

Secretary

MD.,OB-GYN, MSc. Clinical Embryology, MSc.

Epidemiology

9. Lt.Col. Parichat Yingprasert Asst.

Secretary

BSc. Nursing, MA.OM

Biomedical research No

.

Rank Name Surname Position Qualification

1. Maj.Gen. Aphornpirom Ketupanya Chair M.D., MSc. (Clinical epidemiology)

OB-GYN, Maternal and Fetal Medicine,

Prenatal Genetics.

2. Assoc.Prof. Pornthep Chanthavanich Vice Chair M.D., Pediatrics, Infectious Diseases, Family Medicine,

Tropical Medicine, Prevention Medicine.

3. Col. Sangkae Chamnanvanakij Member M.D., Pediatrics, Neonatologist, , Family Medicine, M.Sc.

Clinical Epidemiology,WIRB Fellow

4. Assoc.Prof. Waipoj Chanvimalueng Member M.D.,Otolaryngology, Family Medicine, Facial Plastic and

Reconstructive Surgery

5. Col. Suthee Panichkul Member M.D.,OB-

GYN,FamilyMedicine,M.Sc.ClinicalEpidemiology,WIRB

Fellow

6. Asst. Prof. Dr. Nuttawut

Saelim Member Pharm.D.,Ph.D.

7. Prof. Dr. Ratanavadee Nanagara Member Rheumatology

8. Dr. Wilasinee Chaiyasit Member Psychiatry

9. Miss Jareewan Thienjeen Member LL.B (Bachelor of Laws) , Master of Laws , Thai Barister

10. Miss Busaba Supawattanabode

e

Secretary MSc. biostatistics , WIRB Fellow, BSc. Nursing

11. Lt.Col. Parichat Yingprasert Asst. Secretary BSc. Nursing, MA.OM

No

.

Rank Name Surname Position Qualification

1. Prof.Emeritus Santhat Sermsri Chair B.Sc. Anthropology and Sociology, MA. Sociology

Demography, Ph.D.,Demography

2. Assoc.Prof. Kingfa Sintoovongse Vice Chair Ph.D. Educational Research and Evaluation in

Science Education

3. Assoc.Prof. Khemika Yamarat Member B.A. Education, M.A. Sociology, Ph.D. ,

Demography

4. Assoc.Prof. Siwarak Siwarom Member B.A. history, M.A. history, Ph.D. Social philosophy

5. Mrs. Wanawan Doherty Member Ph.D. Mass Communication

6. Miss Pranee Channarong Member B.Sc.(Psychology) ,M.Sc.(Clinical Psychology)

7. Mr. Amnart Bubparmard Member Ph.D.of Laws , Thai Barister

8. Miss Busaba Supawattana

bodee

Secretary MSc. biostatistics , WIRB Fellow, BSc. Nursing

9. Mr. Jaggapan Cadchumsang Asst.

Secretary

Ph.D. Anthropology

No

.

Rank Name Surname Position Qualification

1. Prof.Emeritus Santhat Sermsri Chair B.Sc. Anthropology and Sociology, MA.

Sociology Demography, Ph.D.,Demography

2. Assoc.Prof. Khemika Yamarat Vice Chair B.A. Education, M.A. Sociology, Ph.D. ,

Demography

3. Assoc.Prof. Siwarak Siwarom Member B.A. history, M.A. history, Ph.D. Social

philosophy

4. Mrs. Wanawan Doherty Member Ph.D. Mass Communication

5. Mr. Amnart Bubparmard Member Ph.D.of Laws , Thai Barister

6. Assoc.Prof. Dr. Rudee Surarit Member Ph.D. (Oral Biology)

Oral Biochemistry, Enzymology, Protein

Chemistry

7. Lt.Col. Parichat Yingprasert Member BSc. Nursing, MA.OM

8. Miss Pranee Channarong Secretary B.Sc.(Psychology) ,M.Sc.(Clinical Psychology)

Social / Behavioral research

Alternate Members: Members for the Recognized Ethics Committee

by SIDCER FERCAP

• Royal Thai Army Medical Department

• Faculty of Medicine Chulalongkorn University • Department of Development of Thai Traditional and Alternative

Medicine Ministry of Public Health • Central Research Ethics Committees • Faculty of Medicine Chiang Mai University • Research Institute for Health Sciences , Human Experimentation

Committee, Chiang Mai University • Khon Kaen University • Faculty of Environment and Resource Studies, Chulalongkorn University • Faculty of Tropical Medicine, Mahidol University • Faculty of Medicine, Siriraj, Mahidol University • Faculty of Medicine, Thammasat University • Faculty of Medicine, Vajira Hospital

Only Multicenter Study (either clinical or health related

social study)

New scope for protocol submission

• โครงการวจยทเปนพหสถาบน (multicenter study) • โครงการวจยของสถาบนทไดรบทนสนบสนนจากหนวยงานกลางของ

รฐบาล เชน ส านกงานคณะกรรมการวจยแหงชาต (วช.) ส านกงานกองทนสนบสนนการสรางเสรมสขภาพ (สสส.) สถาบนวจยระบบสาธารณสข (สวรส.) เปนตน(Sponsor by government agency)

• โครงการวจยของสถาบนหรอหนวยงานทไมมคณะกรรมการจรยธรรมการวจยของสถาบน ( The research institute that no EC.)

CREC SOP version 2

• Version 2.0 • Effective date July 4 2014 • Cover all function of the Ethics committee • Revised chapter for continuing Review of Study

protocols according to US FDA: Guidance for IRBs, Clinical Investigators, and Sponsors . IRB Continuing Review after Clinical Investigation Approval,(Feb 2012)

SOP • Preparation and Revision of Standard

Operating Procedures

• Constituting the Central Research Ethics Committee

• Confidentiality Agreement and Conflict of Interest

• Management of Protocol Submission

• Full board Review

• Expedited Review

• Review of Medical Device Study

• Review and Assessment Guideline

• Review of Adverse Event Report

• Review of Final Reports

• Management of Study Termination

• Non-Compliance/Protocol Deviation/Violation

• Response to Subject Complaint

• Preparation of Meeting Agenda and Minutes

• Management of Study Files

• Site Monitoring Visits

WORK LOAD

Y E A R 2 0 1 3

Initial protocol = 2

Amendment = 8

SAE =29

Progress report =7

Final report =7

Deviation = 3

Termination = 3

Y E A R 2 0 1 4

Initial protocol = 25

Amendment = 7

SAE =5

Progress report = 11

Final report =4

Deviation = 3

Termination = 1

YEAR 2015

Initial protocol = 3

Amendment = 2

SAE =6

Progress report = 2

Final report =1

Deviation = 2

Termination = 0

TOWARD EXCELLENCE

Goal

Thailand is one among many countries conducting sponsored clinical trials

Key success factor

Efficient Ethics Committees

Quality of review

Turn around time (speed)

TURN AROUND TIME 2014

C O M P L E T E D O C U M E N T S

T O B O A R D M E E T I N G

Mean = 9.0 days

Median = 7.5 days

Max =24 days

Min =1days

T I M E T O L E T T E R A F T E R

D E C I S I O N

Mean = 3.0 days

Median = 3.0 days

Max =4 days

Min =1 days

TURN AROUND TIME 2015

C O M P L E T E D O C U M E N T S

T O B O A R D M E E T I N G

Mean = 10.3 days

Median = 8.0 days

Max =19

Min =4

T I M E T O L E T T E R A F T E R

D E C I S I O N

Mean = 3.0 days

Median = 3.0 days

Max =3

Min =3

SIDCER RECOGNITION

PROGRAMME

F E R C A P - S I D C E R S U R V E Y O F A S I A - P A C I F I C I R B S

An IRB is recognized based on the quality of:

1. IRB structure, composition and administration

2. Adherence to specific policies for ethical review

3. Complete review procedures

4. Appropriate after review procedures

5. Documentation and archiving

QUALITY IN ETHICAL REVIEW

Safety

Timely

Efficacy

Equitable

Efficiency

Participant centered

•Risk identified and minimized

• Thorough review within timeline

•Benefit maximized, appropriate study design, protection measures identified eg ICF& procedure

• No COI

• Cost and time spent

• Protect confidentiality

DEFECT IN PROTOCOL REVIEW

Assessment form

Reviewer

SOP Compliance

Competence PI

Vulnerable subjects

Study Design

Risk/Benefit

Insufficiency Inform consents

QUALITY REVIEW ASSESSMENT

QUALITY IMPROVEMENT OF ETHICAL REVIEW

Plan for improvement of quality of

ethical reviews

Used the SIDCER FERCAP tools for

assessment the protocol

Look for defects and get the root cause

analysis

Areas of quality improvement

Possible cause and propose solution

3. COMPLETENESS OF THE REVIEW PROCESS

Recommendations

Protocol File Review (1)

• Complete and write comments and sign the assessment

form(007/57BPm, 008/57BPs, 009/57BPs, 013/57BPs,

008/57BPm, 020/57BPm, 022/57BPs, 024/57BPs)

• Taining the EC Staffs to identify and classify the various

documents submitted and classify them properly

(008/57BPs)

• Potential benefits should be identified by the reviewers

and comment how can be maximized(008/57BPs,

018/57BPs, 016/57BPs)

•

3. COMPLETENESS OF THE REVIEW PROCESS

Recommendations

Protocol File Review (2)

• Consistently choose suitable reviewer with expertise

related to the protocol (006/57BRm, 019/57BPm)

• Determine the vulnerability of patients with stroke,

advanced cancer etc.

(016/57BPs, 018/57BPs, 020/57BPm, 022/57BPs,

023/57BPs)

3. COMPLETENESS OF THE REVIEW PROCESS

Recommendations

Protocol File Review (3)

• Review procedures in obtaining informed

consent(008/57BPs, 012/57BPm, 018/57BPs,

019/57BPm, 022/57BPs)

• Comply with SOP in timelines(006/57BRm, 009/57BPs,

012/57BPm, 013/57BPs, 020/57BPm, 023/57BPs,

001/58BPm, 003/58BPm)

PARETO CHART

29%

53%

68%

82%

91% 97%

100% 100%

0%

20%

40%

60%

80%

100%

120%

0

2

4

6

8

10

12

NoncomplianceSOPs

Assessmentform

Vulnerability insufficient ICF Study design Reviewer R/B Competence PI

N=15

ROOT CAUSE ANALYSIS

QUALITY IMPROVEMENT OF ETHICAL REVIEW

Plan for improvement of quality of

ethical reviews

Used the SIDCER FERCAP tools for

assessment the protocol

Look for defects and get the root cause

analysis

Areas of quality improvement

Possible cause and propose solution