JAWATANKUASA ETIKA & PENYELIDIKAN PERUBATAN …jalan rumah sakit, bangsar tel.: 03-2287 4032/2282 0491/2282 9085 59000 kuala lumpur 03-2282 9082/2282 1402/2282 1449 ... pusat dialysis

JAWATANKUASA ETIKA & PENYELIDIKAN PERUBATAN (Medical Research & Ethics Committee) KEMENTERIAN KESIHATAN MALAYSIA d/a Kompleks Institut Kesihatan Negara Blok A, No 1, Jalan Setia Murni U13/52, Seksyen U13, Bandar Setia Alam, 40170 Shah Alam, Selangor. Tel: 03-3362 8888/8205

_________________________________________________________________________

Ruj.Kami: KKM/NIHSEC/ P17-66 (42) Tarikh: 02-January-2020

DR. LIM TECK ONN CLINRESEARCH SDN BHD DR HAJJAH ROSAIDA HJ MOHD SAID HOSPITAL AMPANG DR SATTIAN KOLLANTHAVELU HOSPITAL AMPANG DR ALIF ADLAN MOHD THABIT HOSPITAL BENTONG DR. WAN MOHD RASIS BIN WAN AHMAD KAMIL HOSPITAL BENTONG DOCTOR GHAZALI AHMAD HOSPITAL KUALA LUMPUR DR LOW TICK SENG HOSPITAL PANTAI AYER KEROH DR LEE YEE YAN HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR SENAMJIT KAUR HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR TAN SOEK SIAM HOSPITAL SELAYANG DR WONG HIN SENG HOSPITAL SELAYANG DR LIM EE KENG HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR RAFIDAH ABDULLAH HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR LIU WEN JIUN HOSPITAL SULTANAH AMINAH DATUK DR. MUHAMMAD RADZI ABU HASSAN HOSPITAL SULTANAH BAHIYAH, ALOR SETAR

DR CHING CHEN HUA HOSPITAL SULTANAH BAHIYAH, ALOR SETAR DR SURYATI YAKOB HOSPITAL SUNGAI BULOH DR FARIZ SAFHAN BIN MOHAMAD NOR HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAMLI SEMAN HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAHIM BIN SULONG JABATAN KESIHATAN NEGERI PAHANG DR MORRIS WO CHEE YUEN NOBEL DIALYSIS CENTER TUARAN DR AHMAD FAUZI BIN ABDUL RAHMAN PRIMA DIALYSIS (EXPLORICH) DR GOH BAK LEONG PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN DR EASON CHANG PUSAT DIALISIS NKF - SUPERKIDS TRINITY DR ZAWAWI NORDIN PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN DR LAM SWEE WIN PUSAT DIALISIS NKF - YAYASAN SULTANAH BAHIYAH DR RAMAKRISHNAN A/L SENKODAN PUSAT DIALYSIS MESRA SDN BHD DR ZULKIFLI BIN MOHD SHAH PUSAT HEMODIALISIS DARUL TA'ZIM DR HALIZAH BT MOHAMAD PUSAT HEMODIALISIS IMAN DR FARAHDIZA BINTI BUANG PUSAT HEMODIALISIS IMPIAN KLUANG DR BEE BOON CHEAK PUSAT RAWATAN DIALISIS FUNGATES SUPERFLOW DR BHARATHAN THEVARAJAH PUSAT RAWATAN DIALISIS MUIS - NKF

DR ANITA BHAJAN MANOCHA YAYASAN AKHLAK - NKF TAIPING Dato’/ Tuan/ Puan,

Annual Ethical Renewal for 2020 NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia)

With reference to the ‘Continuing Review Form’ submitted 26-December-2019, we are pleased to inform that the conduct of the above study has been granted approval (via Expedited Review by Chairperson) for a year by the Medical Research & Ethics Comittee, Ministry of Health Malaysia. To renew the approval, a completed ‘Continuing Review Form’ has to be submitted to MREC at least 2 months before the expiry of the approval. The Medical Research & Ethics Committee, Ministry of Health Malaysia operates in accordance to The

International Council for Harmonization of Technical Requirement for Pharmaceutical for Human Use

(ICH) dan Malaysia Guidelines for Good Clinical Practice.

Effective date: 22-January-2020 Until 21-January-2021

Comments (if any): NIL

“BERKHIDMAT UNTUK NEGARA”

Yours sincerely,

(DR HJH SALINA ABDUL AZIZ) Chairman Medical Research & Ethics Committee Ministry of Health Malaysia

JAWATANKUASA ETIKA & PENYELIDIKAN PERUBATAN (Medical Research & Ethics Committee) KEMENTERIAN KESIHATAN MALAYSIA d/a Institut Pengurusan Kesihatan Jalan Rumah Sakit, Bangsar Tel.: 03-2287 4032/2282 0491/2282 9085 59000 Kuala Lumpur 03-2282 9082/2282 1402/2282 1449 Faks: 03-2282 0015

_________________________________________________________________________________________

Ref : KKM/NIHSEC/ P17-66 (40) Date: 29-January-2019

DR. LIM TECK ONN

CLINRESEARCH SDN BHD

DR HAJJAH ROSAIDA HJ MOHD SAID

HOSPITAL AMPANG

DR SATTIAN KOLLANTHAVELU

HOSPITAL AMPANG

DR ALIF ADLAN MOHD THABIT

HOSPITAL BENTONG

DR. WAN MOHD RASIS BIN WAN AHMAD KAMIL

HOSPITAL BENTONG

DOCTOR GHAZALI AHMAD

HOSPITAL KUALA LUMPUR

DR LOW TICK SENG

HOSPITAL PANTAI AYER KEROH

DR LEE YEE YAN

HOSPITAL RAJA PERMAISURI BAINUN, IPOH

DR SENAMJIT KAUR

HOSPITAL RAJA PERMAISURI BAINUN, IPOH

DR TAN SOEK SIAM

HOSPITAL SELAYANG

DR WONG HIN SENG

HOSPITAL SELAYANG

DR LIM EE KENG

HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH

DR RAFIDAH ABDULLAH

HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH

DR LIU WEN JIUN

HOSPITAL SULTANAH AMINAH


_________________________________________________________________________________________

DATO' DR. MUHAMMAD RADZI ABU HASSAN

HOSPITAL SULTANAH BAHIYAH, ALOR SETAR

DR CHING CHEN HUA

HOSPITAL SULTANAH BAHIYAH, ALOR SETAR

DR SURYATI YAKOB

HOSPITAL SUNGAI BULOH

DR FARIZ SAFHAN BIN MOHAMAD NOR

HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN

DR MOHD RAMLI SEMAN

HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN

DR MOHD RAHIM BIN SULONG

JABATAN KESIHATAN NEGERI PAHANG

DR MORRIS WO CHEE YUEN

NOBEL DIALYSIS CENTER TUARAN

DR AHMAD FAUZI BIN ABDUL RAHMAN

PRIMA DIALYSIS (EXPLORICH)

DR GOH BAK LEONG

PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN

DR EASON CHANG

PUSAT DIALISIS NKF - SUPERKIDS TRINITY

DR ZAWAWI NORDIN

PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN

DR LAM SWEE WIN

PUSAT DIALISIS NKF - YAYASAN SULTANAH BAHIYAH

DR RAMAKRISHNAN A/L SENKODAN

PUSAT DIALYSIS MESRA SDN BHD

DR ZULKIFLI BIN MOHD SHAH

PUSAT HEMODIALISIS DARUL TA'ZIM

DR HALIZAH BT MOHAMAD


_________________________________________________________________________________________

PUSAT HEMODIALISIS IMAN

DR FARAHDIZA BINTI BUANG

PUSAT HEMODIALISIS IMPIAN KLUANG

DR BEE BOON CHEAK

PUSAT RAWATAN DIALISIS FUNGATES SUPERFLOW

DR BHARATHAN THEVARAJAH

PUSAT RAWATAN DIALISIS MUIS - NKF

DR ANITA BHAJAN MANOCHA

YAYASAN AKHLAK - NKF TAIPING Dear Sir/ Mdm, AMENDMENTS FOR STUDY: NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia) Your amendment submission dated 22-January-2019 is referred. 2. Amendments of the following have been received and reviewed with reference to the above study:

Documents received and reviewed with reference to the above study:

1. Declaration conflits of interest 2. Addition of new PI & New sites:

i. Dr Low Tick Seng , Pusat Hemodialisis Impian Melaka ii. Dr Farahdiza Binti Buang, Pusat Hemodialisis Impian Kluang iii. Dr Low Tick Seng, Haemodialysis Centre Yayasan Toh Puan Zurina Melaka iv. Dr Low Tick Seng, Murni Dialysis Centre, Bandar Penawar v. Dr Low Tick Seng, Pusat Hemodialisis Syifa (caw. Bkt Gambir) vi. Dr Halizah Binti Mohammad, Pusat Hemodialisis Iman vii. Dr Low Tick Seng , HD Unit Hospital Pantai Ayer Keroh

3. Addition of new Co-Investigators : i. Sister Suhani Binti Jajuri , Pusat Hemodialisis Impian Melaka ii. Sister Koh Poi Teng , Pusat Hemodialisis Impian Melaka iii. Sister Ng Hui Hui, Pusat Hemodialisis Impian Melaka


_________________________________________________________________________________________

iv. SN Tanurekha A/P Vijayan , Pusat Hemodialisis Impian Kluang v. SN Noridahyu Binti Tomiran, Pusat Hemodialisis Impian Kluang vi. Sister Mazni binti Ibrahim, Haemodialysis Centre Yayasan Toh Puan Zurina

Melaka vii. Dr Azizah Bt Abd Hamid, Murni Dialysis Centre, Bandar Penawar viii. SN Siti Norhamimah Binti Mohmad Halid, Murni Dialysis Centre, Bandar

Penawar ix. Sister Wee Kim Lian , Murni Dialysis Centre, Bandar Penawar x. Sister Noor Affida Binti Abdul Rahman, Pusat Hemodialisis Syifa (caw Bkt

Gambir) xi. Sister Norhidayah binti Mohd Yunus , Pusat Hemodialisis Iman xii. SN Nur Aliah Binti Hamidon, Pusat Hemodialisis Iman xiii. Sister Siti Azfaniza binti Mustar , HD Unit Hospital Pantai Ayer Keroh

The Medical Research & Ethics Committee, Ministry of Health Malaysia operates in

accordance to the International Council for Harmonization of Technical Requirement for

Pharmaceutical for Human Use (ICH) and Malaysia Guideline for Good Clinical Practice


Decision by Medical Research & Ethics Committee:

( √ ) Approved

( ) Disapproved

Date of Decision: 29-January-2019 ........................................................

DR HJH SALINA BT ABDUL AZIZ Chairperson Medical Research & Ethics Committee Ministry of Health Malaysia


_________________________________________________________________________

Ruj.Kami: KKM/NIHSEC/ P17-66 (38) Tarikh: 22-January-2019

DR. LIM TECK ONN CLINRESEARCH SDN BHD DR HAJJAH ROSAIDA HJ MOHD SAID HOSPITAL AMPANG DR SATTIAN KOLLANTHAVELU HOSPITAL AMPANG DR ALIF ADLAN MOHD THABIT HOSPITAL BENTONG DR. WAN MOHD RASIS BIN WAN AHMAD KAMIL HOSPITAL BENTONG DOCTOR GHAZALI AHMAD HOSPITAL KUALA LUMPUR DR LOW TICK SENG HOSPITAL PANTAI AYER KEROH DR LEE YEE YAN HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR SENAMJIT KAUR HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR TAN SOEK SIAM HOSPITAL SELAYANG DR WONG HIN SENG HOSPITAL SELAYANG DR LIM EE KENG HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR RAFIDAH ABDULLAH HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR LIU WEN JIUN HOSPITAL SULTANAH AMINAH DATO' DR. MUHAMMAD RADZI ABU HASSAN HOSPITAL SULTANAH BAHIYAH, ALOR SETAR

DR CHING CHEN HUA HOSPITAL SULTANAH BAHIYAH, ALOR SETAR DR SURYATI YAKOB HOSPITAL SUNGAI BULOH DR FARIZ SAFHAN BIN MOHAMAD NOR HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAMLI SEMAN HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAHIM BIN SULONG JABATAN KESIHATAN NEGERI PAHANG DR MORRIS WO CHEE YUEN NOBEL DIALYSIS CENTER TUARAN DR AHMAD FAUZI BIN ABDUL RAHMAN PRIMA DIALYSIS (EXPLORICH) DR GOH BAK LEONG PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN DR EASON CHANG PUSAT DIALISIS NKF - SUPERKIDS TRINITY DR ZAWAWI NORDIN PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN DR LAM SWEE WIN PUSAT DIALISIS NKF - YAYASAN SULTANAH BAHIYAH DR RAMAKRISHNAN A/L SENKODAN PUSAT DIALYSIS MESRA SDN BHD DR ZULKIFLI BIN MOHD SHAH PUSAT HEMODIALISIS DARUL TA'ZIM DR HALIZAH BT MOHAMAD PUSAT HEMODIALISIS IMAN DR FARAHDIZA BINTI BUANG PUSAT HEMODIALISIS IMPIAN KLUANG DR BEE BOON CHEAK PUSAT RAWATAN DIALISIS FUNGATES SUPERFLOW DR BHARATHAN THEVARAJAH PUSAT RAWATAN DIALISIS MUIS - NKF

DR ANITA BHAJAN MANOCHA YAYASAN AKHLAK - NKF TAIPING Dato’/ Tuan/ Puan,

Annual Ethical Renewal for 2019 NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia)

With reference to the ‘Continuing Review Form’ submitted 09-January-2019, we are pleased to inform that the conduct of the above study has been granted approval (via Expedited Review by Chairperson) for a year by the Medical Research & Ethics Comittee, Ministry of Health Malaysia. Please note that the approval is valid until 21-January-2020. To renew the approval, a completed ‘Continuing Review Form’ has to be submitted to MREC within 2 months before the expiry of the approval. The Medical Research & Ethics Committee, Ministry of Health Malaysia operates in accordance to

The International Council for Harmonization of Technical Requirement for Pharmaceutical for Human

Use (ICH) dan Malaysia Guidelines for Good Clinical Practice.

Thank you

“BERKHIDMAT UNTUK NEGARA”

Yours sincerely,

( DR HJH SALINA ABDUL AZIZ) Chairman Medical Research & Ethics Committee Ministry of Health Malaysia


_________________________________________________________________________________________

Ref : KKM/NIHSEC/ P17-66 (36) Date: 26-September-2018

DR. LIM TECK ONN CLINRESEARCH SDN BHD DR HAJJAH ROSAIDA HJ MOHD SAID HOSPITAL AMPANG DR SATTIAN KOLLANTHAVELU HOSPITAL AMPANG DR ALIF ADLAN MOHD THABIT HOSPITAL BENTONG DR. WAN MOHD RASIS BIN WAN AHMAD KAMIL HOSPITAL BENTONG DOCTOR GHAZALI AHMAD HOSPITAL KUALA LUMPUR DR LEE YEE YAN HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR SENAMJIT KAUR HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR TAN SOEK SIAM HOSPITAL SELAYANG DR WONG HIN SENG HOSPITAL SELAYANG DR LIM EE KENG HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR RAFIDAH ABDULLAH HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR LIU WEN JIUN HOSPITAL SULTANAH AMINAH DATO' DR. MUHAMMAD RADZI ABU HASSAN HOSPITAL SULTANAH BAHIYAH, ALOR SETAR DR CHING CHEN HUA HOSPITAL SULTANAH BAHIYAH, ALOR SETAR


_________________________________________________________________________________________

DR SURYATI YAKOB HOSPITAL SUNGAI BULOH DR FARIZ SAFHAN BIN MOHAMAD NOR HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAMLI SEMAN HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAHIM BIN SULONG JABATAN KESIHATAN NEGERI PAHANG DR MORRIS WO CHEE YUEN NOBEL DIALYSIS CENTER TUARAN DR AHMAD FAUZI BIN ABDUL RAHMAN PRIMA DIALYSIS (EXPLORICH) DR GOH BAK LEONG PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN DR EASON CHANG PUSAT DIALISIS NKF - SUPERKIDS TRINITY DR ZAWAWI NORDIN PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN DR LAM SWEE WIN PUSAT DIALISIS NKF - YAYASAN SULTANAH BAHIYAH DR RAMAKRISHNAN A/L SENKODAN PUSAT DIALYSIS MESRA SDN BHD DR ZULKIFLI BIN MOHD SHAH PUSAT HEMODIALISIS DARUL TA'ZIM DR BEE BOON CHEAK PUSAT RAWATAN DIALISIS FUNGATES SUPERFLOW DR BHARATHAN THEVARAJAH PUSAT RAWATAN DIALISIS MUIS - NKF DR ANITA BHAJAN MANOCHA YAYASAN AKHLAK - NKF TAIPING


_________________________________________________________________________________________

Dear Sir/ Mdm, AMENDMENTS FOR STUDY: NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia) Your amendment submission dated 02-September-2018 is referred. 2. Amendments of the following have been received and reviewed with reference to the above study:


PI & New sites:

1. Pusat Rawatan Dialisis MUIS NKF: Dr Bharathan A/L Thevarajah 2. Prima Dialisis Lagenda Putra Kulai Dr Ahmad Fauzi Abd Rahman 3. Prima Dialisis Masai - Dr Ahmad Fauzi Abd Rahman

Co-Investigators :

1. Hospital Raja Perempuan Bainun, Ipoh, Perak: Dr Thong Kah Mean (MREC MOH approval for Principal Investigator Dr Lee Yee Yan was obtained on the 05 June 2017)

2. Prima Dialisis Lagenda Putra Kulai: Sister Felicia Ak Nanang 3. Prima Dialisis Masai: Sister Rohana Binti Mohamed 4. Pusat Rawatan Dialisis MUIS NKF: Sister Wong Chang Laun

The Medical Research & Ethics Committee, Ministry of Health Malaysia operates in accordance to the

International Council for Harmonization of Technical Requirement for Pharmaceutical for Human Use

(ICH)



( √ ) Approved via Expedited Review

( ) Disapproved

Date of Decision: 21-September-2018 ........................................................



_________________________________________________________________________________________

Ref : KKM/NIHSEC/ P17-66 ( 34 ) Date: 13-August-2018



_________________________________________________________________________________________

DR SURYATI YAKOB HOSPITAL SUNGAI BULOH DR FARIZ SAFHAN BIN MOHAMAD NOR HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAMLI SEMAN HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAHIM BIN SULONG JABATAN KESIHATAN NEGERI PAHANG DR MORRIS WO CHEE YUEN NOBEL DIALYSIS CENTER TUARAN DR AHMAD FAUZI BIN ABDUL RAHMAN PRIMA DIALYSIS (EXPLORICH) DR GOH BAK LEONG PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN DR EASON CHANG PUSAT DIALISIS NKF - SUPERKIDS TRINITY DR ZAWAWI NORDIN PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN DR LAM SWEE WIN PUSAT DIALISIS NKF - YAYASAN SULTANAH BAHIYAH DR RAMAKRISHNAN A/L SENKODAN PUSAT DIALYSIS MESRA SDN BHD DR ZULKIFLI BIN MOHD SHAH PUSAT HEMODIALISIS DARUL TA'ZIM DR BEE BOON CHEAK PUSAT RAWATAN DIALISIS FUNGATES SUPERFLOW DR ANITA BHAJAN MANOCHA YAYASAN AKHLAK - NKF TAIPING


_________________________________________________________________________________________

Dear Sir/ Mdm, AMENDMENTS FOR STUDY: NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia) Your amendment submission dated 02-August-2018 is referred. 2. Amendments of the following have been received and reviewed with reference to the above study:


Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia (Protocol Number: HR2017-01) Ver 3.3 01/08/2018

Patient Information Sheet and Consent Form for a. English Version 2.1 dated 09/07/2018 b. Bahasa Malaysia Version 2.1 dated 09/07/2018 c. Chinese Version 2.1 dated 09/07/2018

New sites and Site Principal Investigators 1. Dr Morris Wo Chee Yuen - Cheras Dialysis Centre 2. Dr Ramakrishnan A/L Senkodan - Pusat Dialysis Mesra Kuala Selangor 3. Dr Ramakrishnan A/L Senkodan - Pusat Dialysis Mesra Kapar 4. Dr Ramakrishnan A/L Senkodan - Pusat Dialysis Mesra Sg Buloh

Co-Investigators : 1. Sister Ang Bee Moy - Pusat Dialisis NKF - Kelab Lions Alor Star 2. Sister Fatimah bt. Hasin - Pusat Rawatan Dialisis Tuanku Syed Putra - NKF 3. Sister Puspa a/p Arjunan - Pusat Dialisis NKF - Yayasan Sultanah Bahiyah 4. SN Nurul Ainn Binti Mohd Sabarani - Pusat Dialisis NKF - Yayasan Buah Pinggang Kemaman 5. SN Nor Hasmiera Binti Md Nor - Pusat Dialisis NKF - Yayasan Buah Pinggang Kemaman 6. Mr Fong Yih - Cheras Dialysis Centre


International Conference on Harmonization Good Clinical Practice Guidelines.


_________________________________________________________________________________________

Comments (if any):



( ) Disapproved

Date of Decision: 07-August-2018 ........................................................


HM/AmendmentApproval2018/Mrecshare


_________________________________________________________________________________________

Ref : KKM/NIHSEC/ P17-66 ( 32 ) Date: 26-June-2018 DR. LIM TECK ONN CLINRESEARCH SDN BHD DR HAJJAH ROSAIDA HJ MOHD SAID HOSPITAL AMPANG DR SATTIAN KOLLANTHAVELU HOSPITAL AMPANG DR ALIF ADLAN MOHD THABIT HOSPITAL BENTONG DR. WAN MOHD RASIS BIN WAN AHMAD KAMIL HOSPITAL BENTONG DOCTOR GHAZALI AHMAD HOSPITAL KUALA LUMPUR DR LEE YEE YAN HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR SENAMJIT KAUR HOSPITAL RAJA PERMAISURI BAINUN, IPOH DR TAN SOEK SIAM HOSPITAL SELAYANG DR WONG HIN SENG HOSPITAL SELAYANG DR LIM EE KENG HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR RAFIDAH ABDULLAH HOSPITAL SULTAN HAJI AHMAD SHAH, TEMERLOH DR LIU WEN JIUN HOSPITAL SULTANAH AMINAH DATO' DR. MUHAMMAD RADZI ABU HASSAN HOSPITAL SULTANAH BAHIYAH, ALOR SETAR DR CHING CHEN HUA HOSPITAL SULTANAH BAHIYAH, ALOR SETAR


_________________________________________________________________________________________

DR SURYATI YAKOB HOSPITAL SUNGAI BULOH DR FARIZ SAFHAN BIN MOHAMAD NOR HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAMLI SEMAN HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAHIM BIN SULONG JABATAN KESIHATAN NEGERI PAHANG DR MORRIS WO CHEE YUEN NOBEL DIALYSIS CENTER TUARAN DR AHMAD FAUZI BIN ABDUL RAHMAN PRIMA DIALYSIS (EXPLORICH) DR GOH BAK LEONG PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN DR EASON CHANG PUSAT DIALISIS NKF - SUPERKIDS TRINITY DR ZAWAWI NORDIN PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN DR LAM SWEE WIN PUSAT DIALISIS NKF - YAYASAN SULTANAH BAHIYAH DR ZULKIFLI BIN MOHD SHAH PUSAT HEMODIALISIS DARUL TA'ZIM DR BEE BOON CHEAK PUSAT RAWATAN DIALISIS FUNGATES SUPERFLOW DR ANITA BHAJAN MANOCHA YAYASAN AKHLAK - NKF TAIPING Dear Sir/ Mdm, AMENDMENTS FOR STUDY: NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia)


_________________________________________________________________________________________

Your amendment submission dated 08-June-2018 is referred. 2. Amendments of the following have been received and reviewed with reference to the above study:


Additional of new sites and investigators:

New Sites:

1. Pusat Dialisis NKF - Good Health, Kampung Pandan 2. Pusat Dialisis NKF – Nanyang Jalan Pahang, Kuala Lumpur 3. Pusat Dialisis-Fungates Superflow, Kepong, Kuala Lumpur

New Investigators:

1. Dr Bee Boon Cheak from Pusat Dialisis-Fungates Superflow, Kepong, Kuala Lumpur (Role as Principal Investigator at the site)

2. Jasvinder kaur A/P Gurunam Singh from Pusat Dialisis NKF - Fungates Superflow, Kepong, Kuala Lumpur (Role as Co-Investigator at Site)

3. Dr Bee Boon Cheak from Pusat Dialisis NKF - Nanyang (Role as Principal Investigator at the site)

4. Junaineh Binti Janiefrom Pusat Dialisis NKF - Nanyang (Role as Co-Investigator at Site) 5. Dr Bee Boon Cheak from Pusat Dialisis NKF - Good Health (Role as Principal Investigator

at the site) 6. Sariah Bt Hussein from Pusat Dialisis NKF - Good Health (Role as Co-Investigator at

Site) 7. Nurul Sahela Binti Yaacob from Pusat Dialisis NKF - Rotary Damansara (Role as Co-

Investigator at Site) 8. Nadia Athirah Binti Norsan from Pusat Dialisis NKF - Rotary Damansara (Role as Co-

Investigator at Site)



Comments (if any):



( ) Disapproved

Date of Decision: 26-June-2018 ........................................................



_________________________________________________________________________________________

Ref : KKM.NIHSEC.P17-66 ( 30 ) Date: 04-June-2018



_________________________________________________________________________________________

DR SURYATI YAKOB HOSPITAL SUNGAI BULOH DR FARIZ SAFHAN BIN MOHAMAD NOR HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAMLI SEMAN HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAHIM BIN SULONG JABATAN KESIHATAN NEGERI PAHANG DR MORRIS WO CHEE YUEN NOBEL DIALYSIS CENTER TUARAN DR AHMAD FAUZI BIN ABDUL RAHMAN PRIMA DIALYSIS (EXPLORICH) DR GOH BAK LEONG PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN DR EASON CHANG PUSAT DIALISIS NKF - SUPERKIDS TRINITY DR ZAWAWI NORDIN PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN DR LAM SWEE WIN PUSAT DIALISIS NKF - YAYASAN SULTANAH BAHIYAH DR ZULKIFLI BIN MOHD SHAH PUSAT HEMODIALISIS DARUL TA'ZIM DR ANITA BHAJAN MANOCHA YAYASAN AKHLAK - NKF TAIPING Dear Sir/ Mdm, AMENDMENTS FOR STUDY: NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia) Your amendment submission dated 18-May-2018 is referred.


_________________________________________________________________________________________

2. Amendments of the following have been received and reviewed with reference to the above study:


1. New site and Investigator: a. Dr Lam Swee Win Pusat Dialysis NKF- Yayasan Sultanah Bahiyah, Kulim, Kedah as

the Principal Investigator at the site

2. Co-Investigator for the approved sites:

a. Fanny Bt Paukin as Co-Investigator from Nobel Dialysis Center Tuaran Sabah

b. Kumutham A/P N.Raman as Co-Investigator from Nobel Dialysis Center Kota

Kinabalu Sabah

c. Sr Siti Fatimah bt. Basir as Co-Investigator from Pusat Dialisis NKF - Dato Dr.

G.A.Sreenevasan

d. Sr Salma bt. Mahmud as Co-Investigator from Pusat Dialisis NKF - Superkids Trinity-

Dr Eason Chang.

e. Sr Wan Suriyani bt. Abdullah as Co-Investigator from Pusat Dialisis NKF - Yayasan

Buah Pinggang Kemaman

f. Sr Chuah Bee Bee as Co-Investigator from Pusat Dialisis NKF - Yayasan Dialisis

Pertubuhan Pendidikan Akhlak, Taiping (Moral Uplifting Society(MULS) - NKF

Taiping, Perak)

g. SN Suraya Abd Rasep as Co-Investigator from Pusat Dialisis NKF - Yayasan Dialisis

Pertubuhan Pendidikan Akhlak, Taiping (Moral Uplifting Society(MULS) - NKF

Taiping, Perak)

h. Sr Zainon Sarinin as Co-Investigator from Pusat Hemodialysis Darul Ta'zim



Comments (if any):



( ) Disapproved

Date of Decision: 04-June-2018 ........................................................


HM/AmendmentApproval2018/Mrecshare


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Ref : KKM/NIHSEC/ P17-66 ( 28 ) Date: 28-March-2018



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DR SURYATI YAKOB HOSPITAL SUNGAI BULOH DR FARIZ SAFHAN BIN MOHAMAD NOR HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAMLI SEMAN HOSPITAL TENGKU AMPUAN AFZAN, KUANTAN DR MOHD RAHIM BIN SULONG JABATAN KESIHATAN NEGERI PAHANG DR MORRIS WO CHEE YUEN NOBEL DIALYSIS CENTER TUARAN DR AHMAD FAUZI BIN ABDUL RAHMAN PRIMA DIALYSIS (EXPLORICH) DR GOH BAK LEONG PUSAT DIALISIS NKF - DATO DR. G.A.SREENEVASAN DR EASON CHANG PUSAT DIALISIS NKF - SUPERKIDS TRINITY DR ZAWAWI NORDIN PUSAT DIALISIS NKF - YAYASAN BUAH PINGGANG KEMAMAN DR ZULKIFLI BIN MOHD SHAH PUSAT HEMODIALISIS DARUL TA'ZIM DR ANITA BHAJAN MANOCHA YAYASAN AKHLAK - NKF TAIPING Dear Sir/ Mdm, AMENDMENTS FOR STUDY: NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia) Your amendment submission dated 14-March-2018 is referred. 2. Amendments of the following have been received and reviewed with reference to the above study:


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Additional of Site and Investigators: Pusat Hemodialysis Darul Ta'zim - Dr Zulkifli Bin Mohd Shah (Principal Investigator at the site) Pusat Dialisis NKF - Yayasan Dialisis Pertubuhan Pendidikan Akhlak, Taiping (Moral Uplifting Society(MULS) - NKF Taiping, Perak) -Dr Anita Bhajan Manocha (Principal Investigator at the site) Pusat Dialisis NKF - Kelab Lions Alor Star -Dr Ching Chen Hua (Principal Investigator at the site) Pusat Rawatan Dialisis Tuanku Syed Putra - NKF - Dr Eason Chang. (Principal Investigator at the site) Pusat Dialisis NKF - Superkids Trinity- Dr Eason Chang. (Principal Investigator at the site) Pusat Dialisis NKF - Rotary Damansara -Dr Goh Bak Leong (Principal Investigator at the site) Pusat Dialisis NKF - Dato Dr. G.A.Sreenevasan- Dr Goh Bak Leong (Principal Investigator at the site) Pusat Dialisis NKF - Yayasan Buah Pinggang Kemaman - Dr Zawawi Bin Nordin (Principal Investigator at the site)



Comments (if any):



( ) Disapproved

Date of Decision: 21-March-2018 ........................................................



_________________________________________________________________________________________

Ref :KKM.NIHSEC.P17-66(26) Date: 23-February-2018

Dr. Lim Teck Onn

ClinResearch Sdn Bhd

Dr Hajjah Rosaida Hj Mohd Said

Dr Sattian Kollanthavelu

Hospital Ampang

Dr Alif Adlan Mohd Thabit Dr. Wan Mohd Rasis Bin Wan Ahmad Kamil Hospital Bentong

Dr Ghazali Ahmad

Hospital Kuala Lumpur

Dr Lee Yee Yan

Dr Senamjit Kaur Hospital Raja Permaisuri Bainun, Ipoh

Dr Tan Soek Siam

Dr Wong Hin Seng

Hospital Selayang

Dr Lim Ee Keng

Dr Rafidah Abdullah

Hospital Sultan Haji Ahmad Shah, Temerloh

Dr Liu Wen Jiun

Hospital Sultanah Aminah

Dato' Dr. Muhammad Radzi Abu Hassan

Dr Ching Chen Hua

Hospital Sultanah Bahiyah, Alor Setar

Dr Suryati Yakob

Hospital Sungai Buloh

Dr Fariz Safhan Bin Mohamad Nor Dr Mohd Ramli Seman

Hospital Tengku Ampuan Afzan, Kuantan

Dr Mohd Rahim Bin Sulong


_________________________________________________________________________________________

Jabatan Kesihatan Negeri Pahang

Dr Morris Wo Chee Yuen

Nobel Dialysis Center Tuaran

Dr Ahmad Fauzi Bin Abdul Rahman

Prima Dialysis (Explorich) Dear Sir/ Mdm, AMENDMENTS FOR STUDY: NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 Community screening and Prevalence of Hepatitis C and B in Pahang Malaysia based on low cost Point of Care Screening Tests (Community screening using low cost Point of Care tests, Assessment of disease activity using Nucleic Acid Tests and Outcome of patients treated with personally imported generic Anti-virals, for Chronic Hepatitis C and B in Malaysia) Your amendment submission dated 08-February-2018 is referred. 2. Amendments of the following have been received and reviewed with reference to the above study:


Study Protocol Version 3.2, dated 24th January 2018 Additional of Site and Investigators: 1.Nobel Dialysis Center Kota Kinabalu Sabah - Dr Morris Wo Chee Yuen (Principal Investigator at the site) 2.Nobel Dialysis Center Tuaran Sabah- Dr Morris Wo Chee Yuen (Principal Investigator at the site) 3.Prima Dialysis (Explorich), Kluang, Johor - Dr Ahmad Fauzi Bin Abdul Rahman (Principal Investigator at the site) and Mr Chee Fook Wah (Co-Investigator)

The Medical Research & Ethics Committee, Ministry of Health Malaysia operates in

accordance to the International Conference of Harmonization Good Clinical Practice

Guidelines.


_________________________________________________________________________________________

Comments (if any):



( ) Disapproved

Date of Decision: 23 -February-2018 ........................................................



_________________________________________________________________________

Ruj.Kami:KKM.NIHSEC.P17-66 (24) Tarikh: 5-Feb-2018

Dr. Lim Teck Onn

Clinresearch Sdn Bhd

Datuk Dr. Muhammad Radzi Abu Hassan Hospital Sultanah Bahiyah, Alor Setar Dato’/Tuan,

Annual Ethical Renewal for 2018:NMRR-16-2391-33614 (IIR) Protocol No : HR2017-01 COMMUNITY SCREENING AND PREVALENCE OF HEPATITIS C AND B IN PAHANG MALAYSIA BASED ON LOW COST POINT OF CARE SCREENING TESTS (COMMUNITY SCREENING USING LOW COST POINT OF CARE TESTS, ASSESSMENT OF DISEASE ACTIVITY USING NUCLEIC ACID TESTS AND OUTCOME OF PATIENTS TREATED WITH PERSONALLY IMPORTED GENERIC ANTI-VIRALS, FOR CHRONIC HEPATITIS C AND B IN MALAYSIA)

With reference to the ‘Continuing Review Form’ submitted 25-January-2018, we are pleased to inform that the conduct of the above study has been granted approval (via Expedited Review by Chairperson) for a year by the Medical Research & Ethics Comittee, Ministry of Health Malaysia. Please note that the approval is valid until 4-Feb-2019. To renew the approval, a completed ‘Continuing Review Form’ has to be submitted to MREC within 1 month before the expiry of the approval. The MREC, Ministry of Health Malaysia operates in accordance to the International Harmonization Good Clinical Practice Guidelines. Thank you. “BERKHIDMAT UNTUK NEGARA” Yours sincerely, ................................................................ (DR HAJAH SALINA BINTI ABDUL AZIZ) Chairperson Medical Research & Ethics Committee Ministry of Health Malaysia SMN/Annualrenewal2018/MRECShare