มาตรฐานคณะกรรมการจริยธรรมการวิจัยในมนุษย์ (มคจม.)

¡“μ√∞“π
§≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®¬— „π¡π…ÿ ¬å

(¡§®¡.)

Õ¿π‘ π— ∑π“°“√®“°
 ”π°— ß“π§≥–°√√¡°“√«®‘ —¬·Àßà ™“μ‘ («™.)

 ”π—°ß“π§≥–°√√¡°“√«®‘ —¬·Ààß™“μ‘ («™.)
æ.». Úıˆ

¡“μ√∞“π§≥–°√√¡°“√®√¬‘ ∏√√¡°“√«®‘ ¬— „π¡πÿ…¬å

æ¡‘ æå§√È—ß∑Ë’ Ò : Ò, ‡≈à¡ æ.». Úııˆ
æ‘¡æ§å √—Èß∑Ë’ Ú : Ú, ‡≈¡à æ.». Úıı¯
æ¡‘ æå§√—Èß∑Ë’ Û : Ù, ‡≈à¡ æ.». Úıˆ

æ‘¡æå∑Ë’
‚√ßæ‘¡æå·Àßà ®ÿÓ≈ß°√≥¡å À“«∑‘ ¬“≈¬— [ˆ¯-˘ˆ]
∂. æ≠“‰∑ ·¢«ß«ß— „À¡à ‡¢μª∑ÿ¡«—π °√ßÿ ‡∑æœ ÒÛÛ
‚∑√. Ú-ÚÒ¯-ÛıÙ˘-ı
http://www.cuprint.chula.ac.th

§”π”

 ”π°— ß“π§≥–°√√¡°“√«®‘ ¬— ·Àßà ™“μ‘ («™.) ‡ÀπÁ §«“¡ ”§≠— ¢Õߧ≥–°√√¡°“√
®√¬‘ ∏√√¡°“√«®‘ ¬— „π¡π…ÿ ¬å (§®¡.) ª√–®” ∂“∫π— ´ß÷Ë ¡À’ π“â ∑’Ë„π°“√ª°ªÕÑ ß §¡âÿ §√Õß ∑‘ ∏‘
 «— ¥‘¿“æ §«“¡ª≈Õ¥¿—¬ ·≈–§«“¡‡ªìπÕ¬àŸ∑’Ë¥’¢Õߺ⟇¢â“√à«¡°“√«‘®—¬À√◊ÕÕ“ “ ¡—§√
∑’ˇ¢â“ Ÿà‚§√ß°“√«®‘ ¬— °“√∑”Àπâ“∑Ë¢’ Õß §®¡. ®÷߇ªπì  «à 𠔧≠— ∑™’Ë à«¬æ≤— π“„Àßâ “π«‘®—¬
¢Õß ∂“∫—ππ—Èπ Ê ¡’§ÿ≥¿“æ ª≈Õ¥¿—¬·°àÕ“ “ ¡—§√ ‰¥âº≈ß“π«‘®—¬∑’ˇ™◊ËÕ∂◊Õ‰¥â ·≈–
‡°‘¥ª√–‚¬™πåμàÕ —ߧ¡ «™. ‰¥â®—¥„Àâ¡’√–∫∫°“√ª√–°—π§ÿ≥¿“æ°“√ªØ‘∫—μ‘Àπâ“∑’Ë¢Õß
§≥–°√√¡°“√®√¬‘ ∏√√¡°“√«®‘ ¬— „π¡π…ÿ ¬å ª√–®” ∂“∫π— ‚¥¬æ≤— π“¡“μ√∞“π§≥–°√√¡°“√
®√¬‘ ∏√√¡°“√«‘®¬— „π¡π…ÿ ¬å (¡§®¡.) ´÷Ëߪ√–°Õ∫¥«â ¬ ı ¡“μ√∞“π ‚¥¬Õâ“ßÕß‘ ·π«∑“ß
 “°≈¢ÕßÕߧ尓√Õπ“¡—¬‚≈° (WHO Operational Guidelines for Ethics
Committee That Review Biomedical Research, 2000 À√◊Õ Silver Book,
Standards and Operational Guidance for Ethics Review of Health-Related
Research with Human Participants, WHO 2011), ¡“μ√∞“π°“√√∫— √Õߧ≥ÿ ¿“æ¢Õß
SIDCER (The Strategic Initiative for Developing Capacity of Ethical Review,
SIDCER Recognition Program) ·≈–·π«∑“ß ”À√—∫°“√∑”«‘®—¬∑“ߧ≈‘π‘°∑’Ë¥’
(ICH GCP Guideline, 1996) μ“¡∑Ë’√–∫ÿ‰«â„π·μà≈–¢âÕ¢Õß¡“μ√∞“π  ”π—°ß“π
§≥–°√√¡°“√«®‘ ¬— ·Àßà ™“μ‘ ®–„™â ¡§®¡. „π√–∫∫°“√√∫— √Õߧ≥ÿ ¿“æ¡“μ√∞“π §≥–°√√¡°“√
®√‘¬∏√√¡°“√«‘®—¬„π¡πÿ…¬å¢Õߪ√–‡∑»‰∑¬ (National Ethics Committee
Accreditation System of Thailand, NECAST)

«™. ‡ÀÁπ ¡§«√®—¥æ‘¡æå ç¡“μ√∞“π§≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®—¬
„π¡πÿ…¬å (¡§®¡.)é ‡æË◊Õ‡º¬·æ√à„Àâ ∂“∫—π §≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®—¬
„π¡πÿ…¬åª√–®” ∂“∫—π ºâŸ«‘®—¬ ·≈–ºâŸ π—∫ πÿπ°“√«‘®—¬ ‰¥â∑√“∫ ·≈–§≥–°√√¡°“√
®√‘¬∏√√¡°“√«‘®—¬ª√–®” ∂“∫—𠉥âæ—≤π“ àŸ¡“μ√∞“π “°≈μÕà ‰ª

(»“ μ√“®“√¬å 𓬷æ∑¬å ‘√‘ƒ°…å ∑√ß»‘«‰‘ ≈)
‡≈¢“∏‘°“√§≥–°√√¡°“√«®‘ ¬— ·Ààß™“μ‘
ı ¡‘∂ÿπ“¬π Úıˆ



 “√∫≠—

‡√Ë◊Õß Àπ“â

¡“μ√∞“π§≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®¬— „π¡π…ÿ ¬å (¡§®¡.) 1
3
¡“μ√∞“π∑Ë’ Ò - ‚§√ß √â“ß·≈–Õߧªå √–°Õ∫¢Õߧ≥–°√√¡°“√
®√‘¬∏√√¡°“√«‘®¬— „π¡π…ÿ ¬å (§®¡.) 7
12
¡“μ√∞“π∑Ë’ Ú - ªØ∫‘ —μ ‘ Õ¥§≈âÕß°—∫π‚¬∫“¬‡©æ“– 21
¡“μ√∞“π∑’Ë Û - «∏‘ ’°“√殑 “√≥“∑∫∑«π 23
¡“μ√∞“π∑’Ë Ù - «‘∏’°“√ªØ‘∫μ— À‘ ≈—ß„À°â “√√—∫√Õß/§«“¡‡ÀπÁ ™Õ∫ 26
¡“μ√∞“π∑Ë’ ı - °“√®¥— °“√‡Õ° “√·≈–°“√‡°Á∫√°— …“‡Õ° “√ 27
31
Standards of Research Ethics Committee (SREC) 36
Standard I - Structure and Composition of the REC 46
Standard II - Adherence to Specific Policies 47
Standard III - Review Procedures
Standard IV - After Review Procedures
Standard V - Documentation and Archiving



¡“μ√∞“π§≥–°√√¡°“√®√‘¬∏√√¡°“√«®‘ —¬
„π¡π…ÿ ¬å (¡§®¡.)

¡“μ√∞“π§≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®—¬„π¡πÿ…¬å (¡§®¡.) ‡ªìπ
¡“μ√∞“π°“√ªØ∫‘ μ— À‘ π“â ∑¢Ë’ Õߧ≥–°√√¡°“√®√¬‘ ∏√√¡°“√«®‘ ¬— „π¡π…ÿ ¬ªå √–®” ∂“∫π—
∑Ë’ ”π—°ß“π§≥–°√√¡°“√«‘®—¬·Ààß™“쑉¥â®—¥∑”¢÷Èπ ‚¥¬Õâ“ßÕ‘ß·π«∑“ß “°≈¢Õß
Õߧ尓√Õπ“¡—¬‚≈° (WHO Operational Guidelines for Ethics Committee
That Review Biomedical Research, 2000 À√◊Õ Silver Book, Standards and
Operational Guidance for Ethics Review of Health-Related Research with
Human Participants, WHO 2011, ¡“μ√∞“π°“√√—∫√Õߧÿ≥¿“æ¢Õß SIDCER
(The Strategic Initiative for Developing Capacity of Ethical Review, SIDCER
Recognition Program) ·≈–·π«∑“ß ”À√—∫°“√∑”«‘®—¬∑“ߧ≈‘π‘°∑’Ë¥’ (ICH GCP
Guideline, 1996) μ“¡∑’Ë√–∫ÿ‰«â„π·μà≈–¢âÕ¢Õß¡“μ√∞“π  ”π—°ß“π§≥–°√√¡°“√
«‘®—¬·Ààß™“μ‘ ®–„™â ¡§®¡. „π√–∫∫°“√√—∫√Õߧÿ≥¿“æ¢Õߪ√–‡∑»‰∑¬ ‡æË◊Õμ√«®
ª√–‡¡‘π„Àâ°“√√—∫√Õߧÿ≥¿“æ¡“μ√∞“π§≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®—¬„π¡πÿ…¬å
¢Õߪ√–‡∑»‰∑¬ (National Ethics Committee Accreditation System of Thailand,
NECAST)

«—μ∂ÿª√– ß§å¢Õß¡“μ√∞“π§≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®—¬„π¡πÿ…¬å
(¡§®¡.)

Ò. ‡æ◊ËÕ„Àâ ∂“∫—πμà“ß Ê ‰¥â„™â‡ªìπ·π«∑“ß„π°“√æ—≤π“°“√¥”‡π‘π°“√
¢Õߧ≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®—¬„π¡πÿ…¬åª√–®” ∂“∫—π„Àâ ‰¥â
¡“μ√∞“π

Ú. ‡æË◊Õ„™â‡ªìπ¡“μ√∞“π„π°“√μ√«®ª√–‡¡‘π·≈–√—∫√Õߧÿ≥¿“æ¡“μ√∞“π
§≥–°√√¡°“√®√‘¬∏√√¡°“√«‘®¬— „π¡π…ÿ ¬å

1

¡“μ√∞“π§≥–°√√¡°“√®√¬‘ ∏√√¡°“√«®‘ —¬„π¡πÿ…¬å (¡§®¡.)
ª√–°Õ∫¥â«¬ ¡“μ√∞“π ı ¥“â π

¡“μ√∞“π∑’Ë Ò - ‚§√ß √â“ß·≈–Õߧªå √–°Õ∫¢Õß §≥–°√√¡°“√®√‘¬∏√√¡
°“√«‘®¬— „π¡π…ÿ ¬å (§®¡.)

¡“μ√∞“π∑Ë’ Ú - ªØ∫‘ μ— ‘ Õ¥§≈Õâ ß°∫— π‚¬∫“¬‡©æ“–
¡“μ√∞“π∑’Ë Û - «‘∏’°“√殑 “√≥“∑∫∑«π
¡“μ√∞“π∑’Ë Ù - «‘∏’°“√ªØ‘∫—μ‘À≈ß— „Àâ°“√√—∫√Õß/§«“¡‡ÀÁπ™Õ∫
¡“μ√∞“π∑’Ë ı - °“√®—¥°“√‡Õ° “√·≈–°“√‡°Á∫√—°…“‡Õ° “√

2

¡“μ√∞“π∑’Ë Ò - ‚§√ß √“â ß·≈–Õߧåª√–°Õ∫¢Õß §®¡.

(‚§√ß √â“ß Õߧåª√–°Õ∫·≈–§«“¡™”π“≠¢Õß°√√¡°“√·≈–‡®â“Àπâ“∑Ë’¡’§«“¡‡À¡“– ¡°—∫ª√‘¡“≥·≈–ª√–‡¿∑¢Õß‚§√ß°“√«‘®—¬
∑æË’ ‘®“√≥“∑∫∑«π)

Ò-Ò ¢Õâ °”À𥇰¬’Ë «°∫—  ¡“™°‘ ¿“æ¢Õß°√√¡°“√ (¡°’ √√¡°“√Õ¬“à ßπÕâ ¬ ı §π Õμ— √“ «à π ‡æ»À≠ß‘ ·≈–‡æ»™“¬ ª√– ∫°“√≥å

‰¡à‡°¬’Ë «¢âÕß°∫— ¥â“π«‘∑¬“»“ μ√å·≈–‰¡à —ß°¥—  ∂“∫—π «“√–/√–¬–‡«≈“°“√‡ªπì °√√¡°“√ ·≈–‡ßÕË◊ π‰¢°“√·μßà μÈß— )

Ò-Ò.Ò ª√–°Õ∫¥â«¬°√√¡°“√Õ¬à“ßπÕâ ¬ ı §π ICH 3.2.1

Ò-Ò.Ú ¡§’ «“¡ ¡¥≈ÿ „π‡√ÕË◊ ßÕ“¬·ÿ ≈–‡æ» WHO 2000, 4

WHO 2011, standard 2

Ò-Ò.Û °√√¡°“√Õ¬“à ßπâÕ¬ Ò §π ∑’Ë¡„‘ ™à‡®â“Àπ“â ∑ ’Ë —ß°¥—  ∂“∫π— π—πÈ ICH 3.2.1, WHO 2000, 4

WHO 2011, standard 2

Ò-Ò.Ù °√√¡°“√Õ¬à“ßπâÕ¬ Ò §π ∑’Ë¡“®“° “¢“Õ“™’æ∑¡Ë’ ‘„™∑à “ß¥“â π«∑‘ ¬“»“ μ√å ICH 3.2.1, WHO 2000, 4

WHO 2011, standard 2

Ò-Ò.ı §®¡. ª√–°Õ∫¥«â ¬°√√¡°“√®“°À≈“°À≈“¬ “¢“§«“¡‡™’¬Ë «™“≠∑Ë’‡À¡“– ¡°—∫ ICH 3.2.1, WHO 2000, 4

‚§√ß°“√«®‘ —¬∑’æË ®‘ “√≥“∑∫∑«π WHO 2011, standard 2

Ò-Ò.ˆ °”Àπ¥∫§ÿ §≈ºâ√Ÿ ∫— º‘¥™Õ∫„π°“√·μßà μßÈ— §≥–°√√¡°“√ WHO 2000, 4.1.1

WHO 2011, standard 9

WHO 2011, Annex 3

Ò-Ò.˜ °√√¡°“√¡ª’ √– ∫°“√≥å §«“¡√⟠§«“¡‡™Ë’¬«™“≠·≈–§«“¡ “¡“√∂∑ˇ’ °¬Ë’ «¢Õâ ß°—∫ WHO 2000, 4

°“√∑”Àπâ“∑Ëμ’ “¡∑μË’ âÕß°“√ WHO 2011, standard 2

3

4

Ò-Ò.¯ §®¡. Õ∏‘∫“¬∂÷ßπ‚¬∫“¬·≈–°√–∫«π°“√‡≈Õ◊ °°√√¡°“√‡æËÕ◊ ·μàßμß—È ICH 3.3.1
WHO 2000, 4.1.2
Ò-Ò.˘ °”À𥫓√–/√–¬–‡«≈“°“√‡ªìπ°√√¡°“√ WHO 2011, standard 9
WHO 2000, 4.2.1
Ò-Ò.Ò „π«“√–°“√‡ªìπ°√√¡°“√ ¡’°“√Õ∏∫‘ “¬π‚¬∫“¬„π°“√‡ª≈’ˬπ°√√¡°“√ WHO 2011, standard 9
Ò-Ò.ÒÒ „π«“√–°“√‡ªπì °√√¡°“√ ¡°’ “√Õ∏‘∫“¬«∏‘ ’°“√„Àâ°√√¡°“√ÕÕ° WHO 2011, Annex 3
WHO 2000, 4.2.2
Ò-Ò.ÒÚ „π«“√–°“√‡ªπì °√√¡°“√ ¡’°“√Õ∏∫‘ “¬«‘∏°’ “√≈“ÕÕ°¢Õß°√√¡°“√ WHO 2011, Annex 3
Ò-Ò.ÒÛ „π«“√–°“√‡ªπì °√√¡°“√ ¡’°“√Õ∏‘∫“¬«∏‘ °’ “√·μßà μ—ßÈ °√√¡°“√∑¥·∑π WHO 2000, 4.2.3
Ò-Ò.ÒÙ §®¡. ‡°∫Á √—°…“∫—≠™’√“¬™◊ËÕ·≈–§≥ÿ  ¡∫μ— ¢‘ Õß°√√¡°“√‰«â WHO 2011, standard 9
Ò-Ò.Òı °√√¡°“√≈ßπ“¡„π¢Õâ μ°≈߇√Õ◊Ë ß°“√√°— …“§«“¡≈—∫ WHO 2011, Annex 3
WHO 2000, 4.2.4
WHO 2011, Annex 3
WHO 2000, 4.2.5
WHO 2011, Annex 3
ICH 3.2.1
WHO 2011, Annex 3
WHO 2000, 4.3.3
WHO 2011, Annex 3

Ò-Ò.Òˆ °√√¡°“√‡μÁ¡„®∑Ë’®–‡ª¥î ‡º¬™ÕË◊ Õ“™’æ·≈–Àπ«à ¬ß“π∑Ë ’ ß— °¥— μàÕ “∏“√≥– ICH 3.4

WHO 2000, 4.3.1

WHO 2011, Annex 3

Ò-Ú ¢âÕ°”Àπ¥‡°Ë’¬«°∫— °“√∫√‘À“√®¥— °“√

(¡®’ ”π«πº∫Ÿâ √À‘ “√‡æ¬’ ßæÕ∑’®Ë –μ√«®μ√“ß“π¢Õß §®¡. ¡ ’ ”π—°ß“π‡ªìπ ¥—  à«π™—¥‡®π ¡’°“√°”Àπ¥Àπ“â ∑’Ë·≈–ß“π¢Õß

‡®“â Àπ“â ∑’Ë «“√–/√–¬–‡«≈“·≈–‡ßËÕ◊ π‰¢°“√∑”Àπâ“∑Ë’‡ªπì ≈“¬≈°— …≥åÕ°— …√)

Ò-Ú.Ò ¡’®”π«π‡®â“Àπâ“∑Ë’ª√–®” ”π°— ß“πÕ¬“à ߇欒 ßæÕ (∑”ß“π‡μÁ¡‡«≈“ À√Õ◊ ∫“߇«≈“) °∫— WHO 2000, 4.4

Àπâ“∑·Ë’ ≈–§«“¡√—∫º¥‘ ™Õ∫‡æ◊ËÕ π∫—  πÿπß“π¢Õß §®¡. WHO 2011, standard 3

WHO 2011, Annex 2

Ò-Ú.Ú §®¡. ¡¢’ âÕ°”Àπ¥·≈–§«“¡μÕâ ß°“√ ”À√∫— °“√¥”‡π‘πß“π„π ”π°— ß“π (‡®“â Àπ“â ∑Ë’„π WHO 2000, 4.4

§®¡. ‡™πà ª√–∏“πœ ‡≈¢“œ) WHO 2011, standard 3

WHO 2011, Annex 2

Ò-Ú.Û π‚¬∫“¬¢Õß §®¡. Õ∏∫‘ “¬∂÷ß«“√–/√–¬–‡«≈“°“√∑”ß“π ‡ßËÕ◊ π‰¢°“√∑”ß“π¢Õß·μà≈– WHO 2000, 4.4
μ”·Àπàß

Ò-Ú.Ù §®¡. ¡‡’ Õ° “√Õ∏∫‘ “¬Àπâ“∑’Ë ¢âÕºŸ°¡¥— ·≈–§«“¡√∫— º‘¥™Õ∫¢Õß·μà≈–μ”·Àπàß (‡™πà WHO 2000, 4.4
°“√°”Àπ¥√–‡∫’¬∫«“√–°“√ª√–™ÿ¡ √“¬ß“π°“√ª√–™¡ÿ °“√·®ßâ º≈°“√殑 “√≥“) WHO 2011, standard 9
¡°’ “√°”Àπ¥«∏‘ ¥’ ”‡ππ‘ °“√∑™Ë’ —¥‡®π‡°Ë’¬«°∫— °“√§¥— ‡≈◊Õ° À√◊Õ°“√·μàßμÈß— μ”·Àπßà μ“à ßÊ WHO 2011, Annex 2
WHO 2000, 4.4
Ò-Ú.ı §®¡. ¡ ’ ”π—°ß“π‡ªìπ ¥— ‡ªìπ à«π WHO 2011, standard 3

5

6

Ò-Ú.ˆ §®¡. ¡Õ’ ÿª°√≥å ”π°— ß“π∑®’Ë ”‡ªπì  ”À√∫— °“√¥”‡π‘πß“π¢Õß ”π—°ß“π WHO 2000, 4
WHO 2011, standard 3
Ò-Ú.˜ §®¡. ¡ß’ ∫ª√–¡“≥∑Ë’®–¥”‡ππ‘ ß“π„À∫â √√≈μÿ “¡Àπ“â ∑’·Ë ≈–§«“¡√∫— º¥‘ ™Õ∫ WHO 2011, Annex 2
WHO 2011, standard 3
Ò-Ú.¯ §®¡. ¡’‡Õ° “√· ¥ß√“¬√∫— √“¬®“à ¬∑’‡Ë °¬Ë’ «¢âÕß°∫— °“√∑”ß“π¢Õß §®¡. ·≈–æ√Õâ ¡ WHO 2011, Annex 2
∑®Ë’ –‡ªî¥‡º¬μàÕ “∏“√≥–‡¡Ë◊Õ¡°’ “√√âÕß¢Õ WHO 2000, 4.3.2
WHO 2011, standard 3
Ò-Û °“√Ωñ°Õ∫√¡ ”À√∫— °√√¡°“√
(§®¡.  ¡§«√®—¥„Àâ°√√¡°“√‰¥â√∫— °“√»÷°…“∑ß—È „π√–¬–‡√‘¡Ë μπâ ·≈–»÷°…“μàÕ‡π◊ËÕß) WHO 2000, 4.7
WHO 2011, standard 5
Ò-Û.Ò „π°“√·μßà μ—ßÈ °√√¡°“√ ¡’°“√√–∫ÿ‡ß◊ËÕπ‰¢‡°’ˬ«°∫— °“√‡¢“â √∫— °“√»°÷ …“Õ∫√¡ WHO 2000, 4.7
∑È—ßÀ≈°—  μŸ √¢Èπ— μπâ ·≈–À≈°—  Ÿμ√°“√»°÷ …“μÕà ‡π◊ÕË ß WHO 2011, standard 5
WHO 2000, 4.7
Ò-Û.Ú °√√¡°“√¢Õß §®¡. ‰¥√â —∫°“√»°÷ …“Õ∫√¡À≈—° μŸ √¢π—È μπâ WHO 2011, standard 5
WHO 2000, 4.7
Ò-Û.Û °√√¡°“√‰¥â√∫— °“√»÷°…“Õ∫√¡‡æ◊ËÕ‡æË¡‘ æπŸ §«“¡ “¡“√∂„π°“√∑∫∑«π殑 “√≥“ WHO 2011, standard 5
¥â“π®√‘¬∏√√¡

Ò-Û.Ù §®¡. ∑∫∑«π·≈–‡°∫Á ‡Õ° “√∑’Ë· ¥ß«“à °√√¡°“√·≈–‡®“â Àπâ“∑’ˉ¥â√∫— °“√»÷°…“Õ∫√¡

Ò-Ù °“√®¥— °“√°√≥’°“√¢¥— ·¬ßâ ∑“ߺ≈ª√–‚¬™πå
(§®¡. æß÷ ¡’π‚¬∫“¬°“√®—¥°“√°√≥°’ “√¢—¥·¬ßâ ∑“ߺ≈ª√–‚¬™π)å

Ò-Ù.Ò §®¡. ¡°’ √–∫«π°“√®¥— °“√°√≥°’ “√¢¥— ·¬ßâ ∑“ߺ≈ª√–‚¬™πå À√◊Õ≈¥ À√Õ◊ ¢®¥— ‰ª WHO 2000, 4.1.3
WHO 2011, standard 4
WHO 2011, Annex 3

¡“μ√∞“π∑’Ë Ú - ªØ∫‘ μ—  ‘ Õ¥§≈Õâ ß°—∫π‚¬∫“¬‡©æ“–

(§®¡. æ÷ß¡°’ “√®¥— °“√∑‡Ë’ À¡“– ¡ ·≈–«∏‘ ’°“√ªØ∫‘ —μ‘∑’‡Ë ªπì ¡“μ√∞“π ”À√∫— °“√殑 “√≥“∑∫∑«π

¥“â π®√‘¬∏√√¡Õ¬à“߇À¡“– ¡∑’ Ë ¥ÿ ·≈–‡ªìπ√–∫∫)

Ú-Ò °“√®—¥°“√¢Õß §®¡.
(§®¡. μâÕß¡’«“√–/√–¬–‡«≈“°“√¥”√ßμ”·Àπàß)

Ú-Ò.Ò §®¡. ¡’¢âÕ°”Àπ¥°“√‡ªπì °√√¡°“√ ´ßË÷ √–∫ÿ¢Õ∫‡¢μ¢Õßß“π «μ— ∂ªÿ √– ß§å ß“π/°‘®°√√¡ WHO 2000, 4

Õߧ°å √·≈–°“√®¥— °“√ WHO 2011, standard 2

WHO 2011, Annex 2,3

Ú-Ú °“√¡’«∏‘ ’¥”‡ππ‘ ß“π∑‡Ë’ ªìπ¡“μ√∞“π

(§®¡. μâÕß¡’«‘∏¥’ ”‡π‘πß“π¡“μ√∞“π∑°’Ë ”À𥇪πì ≈“¬≈—°…≥Õå —°…√ §√Õ∫§≈ÿ¡ß“π·≈–°‘®°√√¡ ´÷ßË §®¡. μÕâ ߪØ∫‘ —μ‘„Àâ Õ¥§≈Õâ ß)

Ú-Ú.Ò §®¡. ¡’«∏‘ ¥’ ”‡π‘πß“π¡“μ√∞“π∑’ˇ¢¬’ π‰«â‡ªìπ≈“¬≈°— …≥Õå °— …√ ICH 3.2.2, WHO 2000, 4

WHO 2011, standard 9

WHO 2011, Annex 3

Ú-Ú.Ú «‘∏’¥”‡ππ‘ ß“π¡“μ√∞“π∑Ë’§√Õ∫§≈¡ÿ Àπ“â ∑’Ë ·≈–°“√æ‘®“√≥“∑∫∑«π∑Èß— À¡¥∑Ë¥’ ”‡ππ‘ °“√ ICH 3.2.2, WHO 2000, 4

‚¥¬ §®¡. WHO 2011, standard 9

7 WHO 2011, Annex 3

8

Ú-Ú.Û §®¡. ªØ∫‘ μ— ‘ Õ¥§≈Õâ ß°∫— «∏‘ ¥’ ”‡ππ‘ ß“π¡“μ√∞“π∑’ˇ¢’¬π‰«â ICH 3.2.2, WHO 2000, 4
WHO 2011, standard 9
Ú-Ú.Ù ¡°’ “√∑∫∑«π·≈–·°â‰¢«‘∏’¥”‡π‘πß“π¡“μ√∞“π‡¡◊ËÕ®”‡ªπì WHO 2011, Annex 3
Ú-Ú.ı §®¡. ‡ªî¥‡º¬ «∏‘ ¥’ ”‡π‘πß“π¡“μ√∞“πμàÕ “∏“√≥– WHO 2011, standard 9
Ú-Û ¢Õâ ·π–π”·≈–¢Õâ °”Àπ¥„π°“√¬◊Ëπ‡ πÕ‚§√ß°“√·≈–°√–∫«π°“√ WHO 2011, Annex 3
ICH 3.2.2
(§®¡. μÕâ ß¡’¢âÕ·π–π”„π°“√¬πË◊ ‡ πÕ‚§√ß°“√ √«¡∑Èß— ¢Õâ °”Àπ¥·≈–·∫∫øÕ√å¡μà“ßÊ) WHO 2011, Annex 3
Ú-Û.Ò §®¡. ¡’¢âÕ·π–𔇰’¬Ë «°—∫°“√¬π◊Ë ‚§√ß°“√«®‘ —¬
Ú-Û.Ú §®¡. ¡·’ ∫∫øÕ√å¡°“√¢Õ¬πË◊ WHO 5.1
Ú-Û.Û §®¡. √–∫ÿ√ªŸ ·∫∫°“√¬πË◊ WHO 2011, Annex 3
Ú-Û.Ù §®¡. √–∫®ÿ ”π«π™¥ÿ ¢Õ߇հ “√∑Ë®’ –¬Ë◊π WHO 2000, 5.2.2
Ú-Û.ı §®¡. √–∫ÿ«∏‘ ’°“√¬◊Ëπ‚§√ß°“√∑¢Ë’ Õ·°â‰¢ ‡ª≈¬Ë’ π·ª≈ß ·≈–°“√√“¬ß“𧫓¡°â“«Àπâ“ WHO 2011, Annex 3
WHO 2000, 5.2.3
√–À«à“ߥ”‡ππ‘ °“√«®‘ —¬ WHO 2011, Annex 3
WHO 2000, 5.2.6
WHO 2011, Annex 3
WHO 2000, 5.2.2
WHO 2011, Annex 3

Ú-Û.ˆ §®¡. ¡§’ ”·π–π”/μ—«·∫∫´÷Ëßæ√Õâ ¡ ”À√—∫™à«¬º«Ÿâ ‘®—¬„π°“√‡μ√’¬¡‡Õ° “√ WHO 2011, Annex 3
Ú-Û.˜ §®¡. ¡«’ ‘∏’°“√≈ß∑–‡∫’¬π ( ”À√∫— °“√μ‘¥μ“¡) °“√¬◊πË ‡æ◊ËÕ¢Õ√∫— °“√殑 “√≥“ WHO 2011, Annex 3
Ú-Û.¯ §®¡. √–∫™ÿ ◊ËÕ·≈–∑Õ’Ë ¬àŸ¢Õß ”π°— ß“π‡≈¢“πÿ°“√ §®¡. ∑Ë’‡ªπì ºŸ√â ∫— ‡Õ° “√°“√¬π◊Ë WHO 2000, 5.2.1
Ú-Û.˘ §®¡. ¡’«∏‘ °’ “√∑’Ë· ¥ß«“à ‰¥√â ∫— ‡√ËÕ◊ ß∑’ˬ◊πË „Àâ §®¡. ·≈«â WHO 2011, Annex 3
Ú-Û.Ò §®¡. ·®âß„Àâºâ¬Ÿ Ë◊π∑√“∫«“à ¢“¥‡Õ° “√„¥∫â“ß WHO 2000, 5.2.8
Ú-Û.ÒÒ §®¡. √–∫ÿÕ—μ√“§“à ∏√√¡‡π’¬¡ (∂â“¡)’  ”À√—∫°“√殑 “√≥“‚§√ß°“√ WHO 2011, Annex 3
Ú-Û.ÒÚ §®¡. √–∫ÿ«à“·∫∫¬πË◊ μâÕß≈ßπ“¡·≈–«—π∑¬Ë’ Ëπ◊ WHO 2000, 5.2.8
Ú-Û.ÒÛ §®¡. °”Àπ¥„Àâ¬Ëπ◊ ‚§√ß°“√«‘®¬— ©∫—∫ ¡∫Ÿ√≥å æ√âÕ¡°—∫‡Õ° “√ª√–°Õ∫·≈–¿“§ºπ«° WHO 2011, Annex 3
WHO 2000, 5.2.11
Ú-Û.ÒÙ §®¡. °”Àπ¥„Àâ¬π◊Ë ‚§√ß°“√«®‘ ¬— ©∫—∫ √ªÿ /¬àÕ ·≈–/À√◊Õ𔇠πÕ‡ªìπ·ºπ¿“æ WHO 2011, Annex 3
Ú-Û.Òı §®¡. °”Àπ¥„Àâ√–∫√ÿ “¬≈–‡Õ¬’ ¥‡°Ë¬’ «°—∫ ç¢âÕ殑 “√≥“¥“â π®√‘¬∏√√¡°“√«®‘ —¬„π¡π…ÿ ¬éå WHO 2000, 5.3.1
WHO 2011, Annex 3
∑‡Ë’ °¬’Ë «¢âÕß°—∫‚§√ß°“√«‘®¬— πÈ—π ICH 3.1.2
WHO 2000, 5.3.2
WHO 2011, Annex 3
WHO 2000, 5.3.3
WHO 2011, Annex 3
WHO 2000, 5.3.4
WHO 2011, Annex 3

9

10 Ú-Û.Òˆ §®¡. °”Àπ¥„À¬â ◊πË ·∫∫∫—π∑÷°¢Õâ ¡≈Ÿ ∫—μ√∫π— ∑÷°√“¬«—π ·≈–·∫∫ Õ∫∂“¡∑®Ë’ –„™â°—∫ WHO 2000, 5.3.5
Ú-Û.Ò˜ º‡Ÿâ ¢â“√à«¡„π°“√«‘®—¬ WHO 2011, Annex 3
Ú-Û.Ò¯ „π°√≥∑’ Ë’‡ªìπ°“√»÷°…“«‘®—¬º≈‘μ¿—≥±å (‡™πà ¬“ À√Õ◊ ‡§√◊ÕË ß¡Õ◊ ) §®¡. °”Àπ¥„À¬â Ë◊π ICH 3.1.2, WHO 2000, 536
¢âÕ √ÿª∑È—ßÀ¡¥∑‡Ë’ °Ë¬’ «°—∫º≈μ‘ ¿≥— ±å∑’Ë»÷°…“Õ¬à“߇撬ßæÕ WHO 2011, Annex 3
Ú-Û.Ò˘ §®¡. °”Àπ¥„À¬â Ëπ◊ ª√–«—μ‘ºŸ«â ‘®¬— ICH 3.1.2,
Ú-Û.Ú WHO 2000, 5.3.7
Ú-Û.ÚÒ §®¡. °”Àπ¥„Àâ¬Ë◊πÕªÿ °√≥åÕπ◊Ë ∑Ë’„™â ”À√∫— °“√‡¢â“∂÷ß/ √√À“/§¥— ‡≈Õ◊ °º∑⟠ÕË’ “®‡ªπì WHO 2011, Annex 3
Õ“ “ ¡§— √º√Ÿâ ∫— °“√«®‘ ¬— ICH 3.1.2
Ú-Û.ÚÚ §®¡. °”Àπ¥„Àâ¬◊πË ·∫∫øÕ√塇հ “√¢âÕ¡≈Ÿ §”Õ∏∫‘ “¬ ”À√∫— ºâŸ∑ËÕ’ “®‡ªπì Õ“ “ ¡§— √ WHO 2000, 5.3.8
Ú-Û.ÚÛ ·≈–„∫¬π‘ ¬Õ¡‡¢â“√«à ¡„π°“√«®‘ —¬ ICH 3.1.2, WHO 5.3.10
Ú-Û.ÚÙ §®¡. °”Àπ¥„ÀâÕ∏‘∫“¬√“¬≈–‡Õ’¬¥§“à ™¥‡™¬μà“ßÊ  ”À√—∫ºŸâ‡¢“â √—∫°“√«‘®¬— (‰¥·â °à WHO 2011, Annex 3
§“à „™®â à“¬·≈–°“√‡¢“â ∂ß÷ °“√√—°…“) ICH 3.1.2
WHO 2000, 5.3.12
§®¡. °”Àπ¥„ÀÕâ ∏‘∫“¬‡°¬Ë’ «°—∫°“√®¥— °“√‡√Ë◊Õß§à“ª√∫— ∂“â ‡°’¬Ë «¢âÕß WHO 2011, Annex 3
WHO 2000, 5.3.13
§®¡. °”Àπ¥„ÀÕâ ∏‘∫“¬‡°Ë’¬«°—∫°“√®¥— °“√‡√◊ËÕß°“√ª√–°—π ”À√∫— Õ“ “ ¡—§√ ∂â“¡’ WHO 2011, Annex 3
WHO 2000, 5.3.14
§®¡. °”Àπ¥„À¬â πË◊ ¢âÕμ°≈ß∑Ë®’ –∂◊ժؑ∫μ— ‘μ“¡À≈°— ®√¬‘ ∏√√¡ ∑Ë’√–∫ÿ„π·π«∑“ß®√‘¬∏√√¡ WHO 2011, Annex 3
∑Ë’‡°’¬Ë «¢âÕß WHO 2000, 5.3.15
WHO 2011, Annex 3

Ú-Û.Úı §®¡. °”Àπ¥„À¬â π◊Ë º≈°“√殑 “√≥“∑’Ë ”§—≠Ê ∑È—ßÀ¡¥°Õà πÀπâ“π∑’È ≈Ë’ ß¡μ‘‚¥¬ §®¡. À√Õ◊ WHO 2000, 5.3.16

Àπ૬ߓπ∑Ë’¡Õ’ ”π“®Àπâ“∑Ë’μ“¡°ØÀ¡“¬ „π°“√æ‘®“√≥“‚§√ß°“√«®‘ ¬— ¥ß— °≈“à « WHO 2011, Annex 3

Ú-Ù ¢Õâ °”Àπ¥°“√ª√–™¡ÿ

(§®¡. §«√‡¢¬’ π¢âÕ°”Àπ¥°“√ª√–™ÿ¡ ´Ë÷ß®–ªØ‘∫—μ‘„À â Õ¥§≈Õâ ß °“√°”Àπ¥Õߧªå √–™¡ÿ ·≈– “¢“«™‘ “™’æ)

Ú-Ù.Ò §®¡. ¡’°“√ª√–™¡ÿ Õ¬à“ß ¡Ë”‡ ¡Õμ“¡°”Àπ¥°“√∑Ë’ª√–°“»‰«â≈«à ßÀπâ“ ICH 3.2.2,
WHO 2000, 6.1 6.1,
WHO 2011, Annex 3

Ú-Ù.Ú §®¡. ®—¥Õߧªå √–™¡ÿ °Õà π∂ß÷ «π— ª√–™ÿ¡ WHO 2000, 4.5

WHO 2011, Annex 3
Ú-Ù.Û §®¡. °”Àπ¥„ÀÕâ ߧªå √–™ÿ¡‡°π‘ °ß÷Ë ÀπË÷ߢÕߧ≥–°√√¡°“√ ·μμà Õâ ߉¡πà Õâ ¬°«“à ı §π WHO 2011, standard 2

‚¥¬¡’°√√¡°“√ Ò §π ∑’ˉ¡à —ß°—¥ ∂“∫—π ·≈– Ò §π∑¡’Ë “®“° “¢“Õ“™æ’ ∑Ë’¡‘„™∑à “ß¥“â π WHO 2011, Annex 3

«‘∑¬“»“ μ√å À√◊Õ°”Àπ¥ WHO 2000, 6.1.3
Ú-Ù.Ù §®¡. °”Àπ¥„À¡â °’ “√∫—π∑°÷ √“¬ß“π°“√ª√–™¡ÿ ·≈–¡’«∏‘ ’°“√„π°“√√—∫√Õß√“¬ß“π WHO 2011, Annex 3

°“√ª√–™ÿ¡

11

12 ¡“μ√∞“π∑’Ë Û - «∏‘ ’°“√æ‘®“√≥“∑∫∑«π

(§®¡. æ‘®“√≥“∑∫∑«π‚§√ß°“√«®‘ —¬·≈–‡Õ° “√ª√–°Õ∫¿“¬„π‡«≈“∑’Ë∑π— °“≈ ‡À¡“–°—∫‡«≈“ μ“¡«‘∏¥’ ”‡ππ‘ °“√∑’‡Ë ¢’¬π‰«‡â æ◊ËÕ
ª°ªÑÕߺ≈ª√–‚¬™πå¢ÕßÕ“ “ ¡§— √„π°“√«‘®¬— )

Û-Ò °√–∫«π°“√æ‘®“√≥“∑∫∑«π

(°√√¡°“√¡’‡«≈“‡æ’¬ßæÕ ”À√—∫°“√殑 “√≥“∑∫∑«π‚§√ß°“√«®‘ —¬ °√√¡°“√‰¥â√—∫‡Õ° “√ ·≈–√“¬≈–‡Õ’¬¥°√–∫«π°“√

殑 “√≥“∑∫∑«π ´ßË÷ ®–ªØ‘∫—μ‘„Àâ Õ¥§≈âÕß)

Û-Ò.Ò §®¡. ªØ∫‘ —μμ‘ “¡«‘∏¥’ ”‡π‘π°“√¡“μ√∞“π„π°“√æ‘®“√≥“∑∫∑«π ICH 3.3, WHO 2000, 6

WHO 2011, Annex 3

Û-Ò.Ú §®¡. æ‘®“√≥“∑∫∑«π‚§√ß°“√«‘®—¬·≈–‡Õ° “√ª√–°Õ∫∑Ë’‡°’ˬ«¢Õâ ß¿“¬„π°√Õ∫√–¬–‡«≈“ ICH 3.1.2, WHO 2000,

∑‡’Ë À¡“– ¡ 6.1.2 WHO 2011, Annex 3

Û-Ò.Û §®¡. ¡«’ ‘∏¥’ ”‡π‘π°“√∑Ë’‰¥ â √“â ߢπÈ÷ ¡“‡æÕ◊Ë °“√æ‘®“√≥“∑∫∑«π‚§√ß°“√«‘®—¬·∫∫‡√Á« ICH 3.3.5, WHO 2000, 6

WHO 2011, Annex 3

Û-Ò.Ù §®¡. √–∫ÿ∂ß÷ ≈—°…≥–°“√¬◊Ëπ‡√ËÕ◊ ß °“√¢Õ·°â‰¢ ‡ª≈’ˬπ·ª≈ß °“√√“¬ß“𧫓¡°â“«Àπ“â ICH 3.3.5, WHO 2000, 6.3.1

·≈–¢Õâ 殑 “√≥“ÕËπ◊ Ê ∑’·Ë  ¥ß«“à ‡¢“â ¢“à ¬°“√殑 “√≥“∑∫∑«π·∫∫‡√«Á WHO 2011, Annex 3

Û-Ò.ı §®¡. ¡π’ ‚¬∫“¬·≈–«‘∏¥’ ”‡ππ‘ °“√∑ËÕ’ ∏∫‘ “¬°√–∫«π°“√∑’Ë„™â„π°“√ª√–‡¡‘π«“à ‚§√ß°“√ ICH 3.3.5, WHO 2000, 6.3.3

«®‘ —¬∑’ˉ¥√â —∫°“√æ‘®“√≥“∑∫∑«π·∫∫‡√«Á ‡¢“â ¢à“¬μ“¡‡°≥±å°“√殑 “√≥“∑∫∑«π·∫∫‡√Á« WHO 2011, Annex 3

À√Õ◊ ‰¡à

Û-Ò.ˆ §®¡. ¡’«∏‘ ’¥”‡π‘π°“√∑’ˉ¥â √â“ߢ÷πÈ ¡“‡æ◊ËÕ°“√æ‘®“√≥“∑∫∑«π‚§√ß°“√«‘®¬— ‚¥¬°√√¡°“√ WHO 2000, 6.2

‡μ¡Á ™ÿ¥ WHO 2011, Annex 3

Û-Ò.˜ §®¡. ¡’°√–∫«π°“√∑Ë’®—¥∑”‰« â ”À√∫— °“√‰¥âºŸâ‡™Ë’¬«™“≠‡æ¡‘Ë ‡¡◊ËÕæ‘®“√≥“∑∫∑«π‚§√ß°“√ ICH 3.3.6, WHO 2000, 4.6

‡©æ“– WHO 2011, standard 2

WHO 2011, Annex 3

Û-Ò.¯ §®¡. ¡¢’ âÕ°”Àπ¥„π°“√∑”Àπâ“∑’ Ë ”À√∫— ∑ªË’ √°÷ …“Õ‘ √– WHO 2000, 4.6,

WHO 2011, standard 2,

WHO 2011, Annex 3

Û-Ò.˘ §®¡. ¡’°√–∫«π°“√∑Ë®’ —¥∑”‰« â ”À√—∫‡™≠‘ ºŸâ¬◊Ëπ/ºŸâ«®‘ ¬— ¡“„À√â “¬≈–‡Õ¬’ ¥„πª√–‡¥πÁ ‡©æ“– ICH 3.2.5, WHO 2011,

‡¡◊ËÕ®”‡ªìπ standard 6

WHO 2011, Annex 3

Û-Ú ‡πÕÈ◊ À“ à«πª√–°Õ∫∑æË’ ‘®“√≥“∑∫∑«π

(§®¡. ¡’π‚¬∫“¬·≈–«‘∏’°“√ ”À√∫— °“√æ‘®“√≥“∑∫∑«π Õߧªå √–°Õ∫∑’Ë殑 “√≥“∑∫∑«π ∑—Èߥâ“πÕÕ°·∫∫°“√«®‘ —¬∑“ß

«‘∑¬“»“ μ√·å ≈–«∏‘ ¥’ ”‡π‘π°“√ ·≈–À≈°— ®√¬‘ ∏√√¡°“√«®‘ —¬)

Û-Ú.Ò §®¡. ¡’π‚¬∫“¬·≈–«‘∏°’ “√ ”À√∫— °“√殑 “√≥“∑∫∑«π‚§√ß°“√«‘®¬— WHO 2000, 6.2

WHO 2011, standard 7

WHO 2011, Annex 3

Û-Ú.Ú §®¡. 殑 “√≥“∑∫∑«π°“√ÕÕ°·∫∫°“√«‘®—¬∑“ß«‘∑¬“»“ μ√å ·≈–«‘∏’¥”‡ππ‘ °“√«®‘ —¬ WHO 2000, 6.2.1

WHO 2011, standard 7

WHO 2011, Annex 3

13 Û-Ú.Û §®¡. æ‘®“√≥“∑∫∑«π‡Àμÿº≈¢Õß°“√„™â°≈àÿ¡§«∫§ÿ¡ WHO 2000, 6.2.1.3

WHO 2011, standard 7

14 Û-Ú.Ù §®¡. æ‘®“√≥“∑∫∑«π‡°≥± å ”À√∫— °“√∂ÕπÕ“ “ ¡§— √„π°“√«®‘ ¬— °àÕπ°”Àπ¥ WHO 2000, 6.2.1.4
Û-Ú.ı WHO 2011, standard 7
Û-Ú.ˆ §®¡. æ‘®“√≥“∑∫∑«π‡°≥±å ”À√—∫À¬ÿ¥°“√«®‘ ¬— À√◊Õ¬ÿμ°‘ “√«®‘ —¬°Õà π°”Àπ¥ WHO 2000, 6.2.1.5
Û-Ú.˜ §®¡. ¡’‡Àμºÿ ≈Õ—π ¡§«√∑’ËæÕ®–∑”𓬧«“¡‡ Ë¬’ ß·≈–§«“¡‰¡ à –¥«° ™—ßË πÈ”Àπ—°‡∑¬’ ∫ WHO 2000, 6.2.1.2
°∫— ª√–‚¬™π∑å ’ËÕ“®‰¥√â ∫— μÕà Õ“ “ ¡—§√„π°“√«‘®¬— ·≈–™¡ÿ ™π∑’Ë√Ÿ â ÷°À«à ß„¬ WHO 2011, standard 7
Û-Ú.¯ §®¡. æ‘®“√≥“∑∫∑«π§«“¡‡æ¬’ ßæÕ¢Õß°“√®¥— ‡μ√’¬¡ ”À√∫— 쥑 μ“¡°”°∫— ¥Ÿ·≈·≈– WHO 2000, 6.2.1.6
Û-Ú.˘ μ√«® Õ∫°“√¥”‡ππ‘ °“√«‘®—¬ √«¡∑ß—È °“√μß—È °√√¡°“√°”°∫— ¥·Ÿ ≈¢Õâ ¡Ÿ≈§«“¡ª≈Õ¥¿¬— WHO 2011, Annex 3
Û-Ú.Ò WHO 2011, standard 9
Û-Ú.ÒÒ §®¡. æ‘®“√≥“∑∫∑«π«∏‘ ’°“√√“¬ß“πº≈°“√«‘®—¬·≈–°“√μ’æ¡‘ æå WHO 2000, 6.2.1.8
Û-Ú.ÒÚ §®¡. 殑 “√≥“∑∫∑«π§«“¡‡ ¬Ë’ ß∑Ë’Õ“®‡°‘¥μÕà Õ“ “ ¡—§√ºâŸ√∫— °“√«‘®—¬ ¡’‡Àμºÿ ≈√—∫‰¥â WHO 2000, 6.2.1.2
Û-Ú.ÒÛ ‡¡◊ËÕ‡∑’¬∫°∫— ª√–‚¬™π∑å ÕË’ “®‰¥â√∫— WHO 2011, standard 8
§®¡. ªØ‘∫—μμ‘ “¡«‘∏’°“√∑Ë°’ ”À𥉫‡â æ◊ËÕ殑 “√≥“«à“§«“¡‡ ’ˬß∑Ë’Õ“®‡ªπì ‰ª‰¥μâ àÕÕ“ “ ¡§— √ ICH 3.1.6
°≈àÿ¡‡ª√“–∫“ß “¡“√∂¬Õ¡√∫— ‰¥â WHO 2011, standard 7
§®¡. æ‘®“√≥“∑∫∑«π«∏‘ ’°“√¢Õß°√–∫«π°“√¢Õ§«“¡¬‘π¬Õ¡‚¥¬‰¥â√—∫¢âÕ¡Ÿ≈ ·≈–°“√ WHO 2000, 6.2.5.1
√–∫ºÿ ∑⟠˒√∫— º‘¥™Õ∫¥”‡π‘π°“√¢Õ§«“¡¬π‘ ¬Õ¡ WHO 2011, standard 7
§®¡. æ‘®“√≥“∑∫∑«π°“√¢Õ§«“¡¬‘π¬Õ¡‚¥¬‰¥√â ∫— ¢âÕ¡≈Ÿ ¡àßÿ ª√–‡¥πÁ «‘∏’°“√∑Ë’∑”„Àâ WHO 2000, 6.2.5.2
ºŸ√â à«¡°“√«‘®¬— ¡§’ «“¡‡¢â“„®¥¢’ πÈ÷ ·≈–μ—¥ ‘π„®¥«â ¬μ—«‡Õß WHO 2011, standard 7
§®¡. 殑 “√≥“∑∫∑«π‡Àμºÿ ≈∑’ Ë ¡§«√∑’Ë®–√«¡Õ“ “ ¡—§√„π°“√«®‘ —¬∑’ˉ¡à “¡“√∂„Àâ ICH 3.1.6
§«“¡¬π‘ ¬Õ¡¥«â ¬μ—«‡Õß ·≈–√“¬≈–‡Õ¬’ ¥°“√®—¥°“√ ”À√∫— °“√‰¥â√—∫§«“¡¬π‘ ¬Õ¡ WHO 2000, 6.2.5.3
WHO 2011, standard 7

Û-Ú.ÒÙ §®¡. ¡’«∏‘ ’°“√∑’°Ë ”À𥉫·â ≈–ªØ‘∫—μ‘μ“¡ ‡æ◊ËÕæ‘®“√≥“«“à ºŸâ√∫— °“√«®‘ ¬— ∑‡’Ë ª√“–∫“߉¥â√—∫ ICH 3.1.5
Û-Ú.Òı °“√ª°ªÑÕß„π°√–∫«π°“√¢Õ§«“¡¬π‘ ¬Õ¡ WHO 2011, standard 7
Û-Ú.Òˆ §®¡. ¡«’ ‘∏’°“√∑Ë’°”À𥉫·â ≈–ªØ‘∫μ— μ‘ “¡„π°“√æ‘®“√≥“∑∫∑«π°√–∫«π°“√¢Õ§«“¡¬‘π¬Õ¡ ICH 3.1.2
Û-Ú.Ò˜ „π ∂“π°“√≥©å °ÿ ‡©π‘ „π‚§√ß°“√«‘®—¬ WHO 2011, standard 7
Û-Ú.Ò¯ §®¡. 殑 “√≥“∑∫∑«π¢Õâ ¡≈Ÿ ∑√’Ë ∫— √Õß°—∫Õ“ “ ¡—§√„π°“√«®‘ ¬— «“à ®–‰¥â√∫— ¢âÕ¡≈Ÿ ∑Ë¡’ ’√–À«à“ß WHO 2000, 6.2.5.4
¥”‡ππ‘ °“√«®‘ —¬∑‡Ë’ °¬’Ë «¢Õâ ß°∫— °“√‡¢â“√«à ¡„π°“√«®‘ ¬— WHO 2011, standard 7
Û-Ú.Ò˘ §®¡. æ‘®“√≥“∑∫∑«π°“√®—¥‡μ√¬’ ¡¢ÕߺŸ«â ®‘ —¬∑’®Ë –√∫— ·≈–μÕ∫ πÕß°“√ Õ∫∂“¡ WHO 2000, 6.2.5.5
Û-Ú.Ú ¢Õâ  ß —¬·≈–¢Õâ √âÕ߇√¬’ π®“°Õ“ “ ¡—§√ À√Õ◊ º·âŸ ∑π„π√–À«à“ߥ”‡ππ‘ °“√∑”«‘®—¬ WHO 2011, standard 6
Û-Ú.ÚÒ §®¡. æ‘®“√≥“∑∫∑«π§«“¡‡À¡“– ¡¥“â π§≥ÿ «ÿ≤·‘ ≈–ª√– ∫°“√≥å¢Õߺ⟫‘®—¬„π‚§√ß°“√ ICH 3.1.3
∑’‡Ë  πÕ WHO 2000, 6.2.3.1
Û-Ú.ÚÚ WHO 2011, standard 7, 10
§®¡. 殑 “√≥“∑∫∑«π·ºπß“π∑®’Ë –∂Õπ À√◊Õ√–ß—∫°“√„Àâ«‘∏’√—°…“¡“μ√∞“π WHO 2000, 6.2.3.2
15 ‡æË◊Õ«μ— ∂ªÿ √– ß§å¢Õß°“√«‘®—¬ ·≈–‡Àμºÿ ≈∑Ë’¬Õ¡√—∫‰¥â„π°“√∑”‡™àππ—Èπ WHO 2011, standard 7
§®¡. æ‘®“√≥“∑∫∑«π¢πÈ— μÕπ∑Ë®’ –ªØ‘∫μ— ∂‘ â“Õ“ “ ¡—§√„π°“√«‘®¬— ∂Õπμ—«ÕÕ°®“° WHO 2000, 6.2.3.5
°“√«‘®¬— ¥«â ¬§«“¡ ¡§— √„®„π√–À«“à ߥ”‡ππ‘ °“√«‘®—¬ WHO 2011, standard 7
§®¡. ¡«’ ‘∏°’ “√∑’Ë°”À𥉫·â ≈–ªØ∫‘ μ— μ‘ “¡„π°“√ª√–‡¡π‘ °“√ª°ªÕÑ ß§«“¡‡ªìπ à«πμ—«·≈– WHO 2000, 6.2.4
°“√√°— …“§«“¡≈∫— ¢ÕßÕ“ “ ¡—§√º√Ÿâ ∫— °“√«®‘ ¬— „π√–À«à“ß·≈–À≈ß— ®“°°“√«‘®¬— ‡ √Á® WHO 2011, standard 7
 ¡∫√Ÿ ≥å
§®¡. ¡«’ ‘∏°’ “√∑Ë°’ ”À𥉫·â ≈–ªØ‘∫μ— μ‘ “¡ ‡æ◊ÕË ª√–‡¡π‘ ·≈–μ¥—  π‘ „®‰¥â«“à ºŸ√â —∫°“√«®‘ —¬∑Ë’ ICH 3.1.6
‡ª√“–∫“߉¥√â —∫°“√ª°ªÑÕßÕ¬à“߇À¡“– ¡ WHO 2011, standard 6

16 Û-Ú.ÚÛ §®¡. ¡’«‘∏’°“√∑Ë°’ ”À𥉫â·≈–ªØ‘∫μ— ‘μ“¡ ‡æÕË◊ ª√–‡¡π‘ ·≈–μ¥—  ‘π„®«à“«‘∏°’ “√∑’Ë„™â„π WHO 2000, 6.2.2
Û-Ú.ÚÙ °“√√«∫√«¡Õ“ “ ¡—§√ºâ√Ÿ —∫°“√«‘®—¬  “¡“√∂¬Õ¡√∫— ‰¥Àâ √◊Õ‰¡à WHO 2011, standard 7
Û-Ú.Úı §®¡. æ‘®“√≥“∑∫∑«π°“√Õ∏‘∫“¬·ºπß“π∑®Ë’ –∑”„Àºâ ≈μ‘ ¿—≥±∑å ’»Ë ÷°…“¡’„ÀâÕ“ “ ¡§— √ WHO 2000, 6.2.3.8
Û-Ú.Úˆ „π°“√«®‘ ¬— À≈ß— ®“°‚§√ß°“√«‘®—¬ ∂â“∑”‰¥â WHO 2011, Annex 3
Û-Ú.Ú˜ §®¡. ¡’«‘∏°’ “√∑Ë°’ ”À𥉫·â ≈–ªØ‘∫—μ‘μ“¡ ‡æÕË◊ ª√–‡¡‘π‡°≥±°å “√§—¥‡¢â“·≈–§¥— ÕÕ° WHO 2000, 6.2.2.4, 6.2.2.5
Û-Ú.Ú¯ WHO 2011, standard 7
§®¡. ¡«’ ‘∏’°“√∑’Ë°”À𥉫â·≈–ªØ‘∫—μμ‘ “¡ ‡æÕ◊Ë ª√–‡¡π‘ ≈°— …≥–ª√–™“°√∑’Ë®–‡™‘≠¡“ WHO 2000, 6.2.2.1
Û-Ú.Ú˘ ‡ªπì ºŸ‡â ¢â“√—∫°“√«‘®¬—
§®¡. ¡«’ ∏‘ °’ “√∑’Ë„À⧫“¡¡Ëπ— „®«à“¡°’ “√‡æ‘¡Ë °“√√°— …“§«“¡ª≈Õ¥¿¬— ‡æËÕ◊ ª°ªÕÑ ß ∑‘ ∏‘ ICH 3.1.6, 3.1.7
Û-Ú.Û §«“¡‡ªπì Õ¬∑Ÿà Ë’¥’„π°“√«®‘ —¬∑’ˇ°Ë’¬«¢âÕß°∫— ª√–™“°√°≈ÿࡇª√“–∫“ß WHO 2011, standard 7
Û-Ú.ÛÒ §®¡. æ‘®“√≥“∑∫∑«π°“√®“à ¬§à“∑¥·∑π„ÀÕâ “ “ ¡—§√º√Ÿâ ∫— °“√«‘®¬— ‡æ◊ËÕ¥«Ÿ “à ®–‰¡à™—°®ßŸ ICH 3.1.8
®π‡°‘π‡Àμÿ‡æ◊ÕË „À⇢â“√—∫°“√«®‘ —¬ WHO 2000, 6.2.3.9
WHO 2011, standard 7
§®¡. æ‘®“√≥“∑∫∑«π°“√™¥‡™¬„ÀâÕ“ “ ¡§— √ºâŸ√∫— °“√«‘®—¬ ‡æ◊ËÕ¥«Ÿ “à ‡æ¬’ ßæÕμÕà °“√ ICH 3.1.9, WHO 2000,
™¥‡™¬°“√∫“¥‡®∫Á À√◊Õ‰¡à 6.2.3.10, 6.2.3.11
WHO 2011, standard 7
§®¡. æ‘®“√≥“∑∫∑«π¡“μ√∞“π°“√¥·Ÿ ≈√°— …“·≈–ª√–‚¬™πÕå ◊πË „¥À≈—ß°“√∑¥≈Õß ∑’Ë®– WHO 2000, 6.2.3.3
„À°â —∫ºŸâ‡¢“â √∫— °“√«®‘ ¬— WHO 2011, Annex 2, 3
§®¡. 殑 “√≥“∑∫∑«πº≈°√–∑∫ ·≈–°“√«®‘ ¬— ∑μË’ √ß°—∫ªí≠À“¢Õß™ÿ¡™π∑Õâ ß∂πË‘ ∑Ë∂’ °Ÿ ¥÷ß WHO 2000, 6.2.6.1
¡“‡ªìπºŸâ‡¢â“√—∫°“√«‘®—¬ WHO 2011, Annex 2

Û-Ú.ÛÚ §®¡. æ‘®“√≥“∑∫∑«π¢π—È μÕπ°“√ªØ∫‘ —μ‘ ∑ªË’ √°÷ …“°∫— ™ÿ¡™π√–À«à“ß°“√ÕÕ°·∫∫ WHO 2000, 6.2.6.2
Û-Ú.ÛÛ
Û-Ú.ÛÙ «‘∏’«‘®—¬ WHO 2011, Annex 2
Û-Ú.Ûı
Û-Ú.Ûˆ §®¡. 殑 “√≥“∑∫∑«πÕ∑‘ ∏æ‘ ≈¢Õß™ÿ¡™πμàÕ°“√„À⧫“¡¬‘π¬Õ¡¢Õß·μ≈à –§π WHO 2000, 6.2.6.3
Û-Ú.Û˜
WHO 2011, Annex 2
Û-Û
§®¡. 殑 “√≥“∑∫∑«π°“√„À⧔ª√÷°…“∑’‡Ë  πÕ„Àâ·°™à ÿ¡™π√–À«à“ߥ”‡π‘π°“√«®‘ ¬— WHO 2000, 6.2.6.4
Û-Û.Ò
WHO 2011, Annex 2

§®¡. æ‘®“√≥“∑∫∑«π¢Õ∫‡¢μ∑°Ë’ “√«‘®¬— ®–™à«¬ √“â ߧ«“¡‡¢â¡·¢Áß¿“¬„π™ÿ¡™π WHO 2000, 6.2.6.5

WHO 2011, Annex 2

§®¡. æ‘®“√≥“∑∫∑«π °“√®¥— „Àâ¡’º≈μ‘ ¿—≥±å∑’˪√– ∫§«“¡ ”‡√Á®„π°“√»÷°…“«®‘ ¬— ·≈– WHO 2000, 6.2.6.6

§«“¡ “¡“√∂„π°“√®¥— ´◊ÕÈ À“‰¥â ·°à™¡ÿ ™πÀ≈ß— ‡ √Á® Èπ‘ °“√«‘®¬— WHO 2011, standard 10

§®¡. æ‘®“√≥“∑∫∑«π ∑‘ ∏‘∑ºË’ Ÿâ√∫— °“√«‘®—¬®–‰¥â√—∫¢Õâ ¡≈Ÿ ‡æ‘Ë¡‡μ¡‘ ‡¡Ë◊Õ¢âÕ¡Ÿ≈ππ—È ®–¡’ WHO 2000, 6.2.5.4

§«“¡À¡“¬μàÕ°“√ª°ªÑÕß ∑‘ ∏‘ §«“¡ª≈Õ¥¿¬— ·≈–§«“¡‡ªπì Õ¬∑àŸ ¥Ë’ ¢’ ÕߺŸ√â ∫— °“√«®‘ —¬ WHO 2011, standard 10

WHO 2011, Annex 2, 3

À≈—ß„À§â «“¡‡ÀÁπ™Õ∫‚§√ß°“√

(§®¡.∑”‡Õ° “√·≈–ªØ∫‘ μ— μ‘ “¡«∏‘ °’ “√殑 “√≥“∑∫∑«π°“√·°â‰¢ ‡ª≈¬Ë’ π·ª≈ß °“√√“¬ß“𧫓¡°“â «Àπ“â √“¬ß“π‡Àμ°ÿ “√≥å

‰¡àæ÷ߪ√– ß§å)

§®¡. ¡°’ “√∑∫∑«π√“¬ß“𧫓¡°â“«Àπ“â ICH 3.1.4, 3.3.3

WHO 2000, 9

WHO 2011, Annex 2, 3

17

18 Û-Û.Ú §®¡. ¡«’ ‘∏’°“√∑®’Ë —¥∑”‰«â·≈–ªØ∫‘ μ— μ‘ “¡  ”À√—∫°”À𥧫“¡∂’¢Ë Õß°“√∑∫∑«π√“¬ß“π ICH 3.1.4

§«“¡°â“«Àπâ“ WHO 2000, 9.2

WHO 2011, Annex 2, 3

Û-Û.Û §®¡. ¡«’ ‘∏’°“√∑®’Ë ¥— ∑”‰«·â ≈–ªØ∫‘ μ— μ‘ “¡  ”À√∫— ®—¥°“√°∫— °“√¢Õ·°â‰¢ ‡ª≈¬Ë’ π·ª≈ß ICH 3.2.7

‚§√ß°“√«‘®—¬ WHO 2000, 9.3

WHO 2011, Annex 2, 3

Û-Û.Ù §®¡. ¡√’ “¬°“√‡Õ° “√∑’μË âÕß°“√ ”À√∫— °“√殑 “√≥“∑∫∑«πμàÕ‡π◊ÕË ßæ√Õâ ¡„À⺫Ÿâ ‘®¬— WHO 2000, 8.11

∑√“∫ WHO 2011, Annex 3

Û-Û.ı §®¡. æ‘®“√≥“¢Õâ ¡≈Ÿ ·≈–‡Õ° “√∑’ˇ°Ë’¬«¢Õâ ß„π°“√æ‘®“√≥“∑∫∑«π√“¬ß“πμÕà ‡π◊ÕË ß WHO 2000, 9.3

WHO 2011, Annex 2

Û-Û.ˆ §®¡. ¡’«‘∏°’ “√∑®’Ë ¥— ∑”‰«â·≈–ªØ∫‘ —μ‘μ“¡ ∑Ë·’ ®âß„À⺟⫑®¬— √“¬ß“πμÕà ‡π◊ÕË ß ‡æÕË◊ §®¡. ICH 3.1.4

®–殑 “√≥“∑∫∑«π‡¡ËÕ◊ ‰√ WHO 2000, 9.4

WHO 2011, standard 10

WHO 2011, Annex 2, 3

Û-Û.˜ §®¡. ¡π’ ‚¬∫“¬·≈–«‘∏’°“√ ´÷ßË ªØ∫‘ μ— μ‘ “¡‡°¬’Ë «°—∫°“√„ÀâÀ¬ÿ¥°“√«®‘ ¬— À√◊Õ¬μÿ ‘°“√«®‘ —¬ WHO 2000, 9.4

°àÕπ°”Àπ¥¢Õß‚§√ß°“√«‘®¬— ∑’ˉ¥√â —∫§«“¡‡ÀπÁ ™Õ∫‰ª·≈â« ∂â“¡’°“√æ∫„π°“√μ√«® WHO 2011, standard 10

쥑 μ“¡À√Õ◊ „π°“√殑 “√≥“∑∫∑«πμàÕ‡πÕË◊ ß

Û-Û.¯ §®¡. °”Àπ¥„À⺟⫮‘ ¬— ·®ßâ μÕà §®¡. ‡ªìπ≈“¬≈°— …≥Õå °— …√∂÷߇Àμºÿ ≈·≈– √ªÿ º≈°“√«‘®—¬ WHO 2000, 9.5

‡¡ËÕ◊ ºŸ¬â πË◊ À¬ÿ¥À√Õ◊ ¬ÿμ‘°“√«®‘ —¬°àÕπ°”Àπ¥ WHO 2011, standard 10

Û-Û.˘ §®¡. æ‘®“√≥“∑∫∑«π°“√μ‘¥μ“¡‡¡◊ÕË ‡°¥‘ ‡Àμ°ÿ “√≥剡æà ß÷ ª√– ß§√å “â ¬·√ß·≈–‰¡§à “¥§‘¥ WHO 2000, 9.3 b
¡“°Õà π ´÷ßË ‡°¥‘ ®“°°“√»÷°…“ À√Õ◊ º≈‘μ¿≥— ±∑å ¥ Õ∫ ·≈–®”‡ªπì μÕâ ß¡¢’ π—È μÕπ WHO 2011, standard 10
Û-Û.Ò ‡æÕË◊ ª°ªÕÑ ßÕ“ “ ¡§— √º√⟠∫— °“√«®‘ ¬—
§®¡. √–∫ÿ«“à ‰¡à„Àâ∑” Ë‘ß∑’‡Ë ∫’ˬ߇∫π‰ª®“°‚§√ß°“√«®‘ —¬ À√Õ◊ °“√‡ª≈’ˬπ·ª≈ߢÕß ICH 3.3.7
Û-Û.ÒÒ ‚§√ß°“√«‘®¬— °àÕπ°“√‰¥â√—∫§«“¡‡ÀπÁ ™Õ∫®“° §®¡. ‡ªπì ≈“¬≈°— …≥åÕ—°…√‡°Ë¬’ «°∫— °“√ WHO 2011, standard 10
·°â‰¢‡ª≈’¬Ë π·ª≈ß∑‡’Ë À¡“– ¡
Û-Û.ÒÚ §®¡. √–∫ÿ„Àºâ «Ÿâ ‘®¬— √“¬ß“πμÕà §®¡.∑—π∑∑’ ’Ë¡°’ “√‡∫’¬Ë ߇∫π‰ª®“°‚§√ß°“√«®‘ ¬— À√Õ◊ ¡’°“√ ICH 3.3.8, WHO 2000,
‡ª≈ˬ’ π·ª≈ߢÕß‚§√ß°“√«‘®—¬ ‡æËÕ◊ ¢®¥— Õ—πμ√“¬μÕà ºŸâ√∫— °“√«®‘ ¬— 9.3 c, WHO 2011,
Û-Û.ÒÛ standard 10
Û-Û.ÒÙ §®¡. √–∫„ÿ Àºâ Ÿ«â ®‘ —¬√“¬ß“πμàÕ §®¡.∑—π∑’∑¡’Ë ’√“¬ß“π°“√‡ª≈Ë’¬π·ª≈ß∑‡’Ë æË¡‘ §«“¡‡ ¬’Ë ß ICH 3.3.8
Û-Û.Òı μÕà º√⟠∫— °“√«®‘ ¬— ·≈–/À√◊Õ¡’º≈°“√∑¥≈ÕßÕ¬à“ß¡’π—¬ ”§≠— WHO 2000, 9.3 c
Û-Û.Òˆ WHO 2011, standard 10
§®¡. √–∫ÿ„À⺟«â ®‘ —¬√“¬ß“πμÕà §®¡.∑π— ∑’∑¡’Ë ’√“¬ß“πÕ“°“√‰¡æà ÷ߪ√– ß§å∑—ÈßÀ¡¥∑ßÈ— ∑’Ë ICH 3.3.8
19 √“â ¬·√ß ·≈–‰¡à§“¥§‘¥¡“°Õà π WHO 2011, Annex 3
§®¡. √–∫„ÿ ÀâºâŸ«®‘ —¬√“¬ß“πμàÕ §®¡.∑—π∑’∑Ë’¡¢’ âÕ¡Ÿ≈„À¡∑à ÕË’ “®¡º’ ≈‰¡æà ÷ߪ√– ß§¥å “â π WHO 2011, standard 10
§«“¡ª≈Õ¥¿¬— μÕà ºŸ√â —∫°“√∑¥≈Õß À√Õ◊ μàÕ°“√∑¥≈Õß
§®¡. °”Àπ¥„Àºâ ¬âŸ Ë◊π‚§√ß°“√·®ßâ §®¡. ‡¡ËÕ◊ °“√»°÷ …“‡ √Á® ¡∫√Ÿ ≥å WHO 2000, 9.6
WHO 2011, Annex 3
§®¡. °”Àπ¥„ÀâºâŸ¬Ëπ◊ ‚§√ß°“√ àß √ªÿ √“¬ß“π°“√«‘®¬— ‡¡ÕË◊ ‡ √Á® ¡∫Ÿ√≥å ´÷ËßÕ∏∫‘ “¬ WHO 2000, 9.7
‡°Ë¬’ «°∫— °“√»÷°…“«®‘ —¬∑”Õ¬à“߉√·≈–¡ ’ √ÿªº≈°“√»°÷ …“«®‘ —¬ WHO 2011, Annex 3

20 Û-Ù §«“¡ ¡∫√Ÿ ≥¢å Õß√“¬ß“π°“√ª√–™ÿ¡ §®¡.

(√“¬ß“π°“√ª√–™¡ÿ §«√‡ªìπ°“√∫—π∑÷°∑’ Ë ¡∫√Ÿ ≥·å ≈– –∑âÕπ°“√°√–∑”∑’‡Ë °‘¥„π√–À«“à ß°“√ª√–™ÿ¡)

Û-Ù.Ò §®¡. ∫—π∑÷°·≈–‡°Á∫√°— …“√“¬ß“π°“√ª√–™¡ÿ ICH 3.2.2

WHO 2000, 6.1.3

Û-Ù.Ú „π√“¬ß“π°“√ª√–™ÿ¡ ¡’∫—π∑°÷ ™Õ◊Ë °√√¡°“√∑Ë’Õ¬Ÿà„π∑˪’ √–™¡ÿ ·μ≈à –§√—Èß °√√¡°“√∑’Ë ICH 3.1.2

≈ߧ–·ππ ·≈–°“√°√–∑”∑È—ßÀ¡¥∑’ˇ°¥‘ ¢πÈ÷ „π°“√ª√–™ÿ¡

Û-Ù.Û √“¬ß“π°“√ª√–™¡ÿ §®¡. ¡°’ “√∫—π∑°÷ ‚§√ß°“√«‘®¬— ·≈–‡Õ° “√ª√–°Õ∫∑’Ëæ‘®“√≥“ ICH 3.1.2

∑∫∑«π«—π∑Ë∑’ ’Ë„À⧫“¡‡ÀÁπ™Õ∫/√—∫√Õß  «à π∑Ë’®”‡ªπì μâÕߪ√—∫ª√ÿß°àÕπ„À⧫“¡‡ÀπÁ ™Õ∫/ WHO 2011, Annex 3

√∫— √Õß‚§√ß°“√ À√◊Õ‰¡à„À⧫“¡‡ÀπÁ ™Õ∫/‰¡à√—∫√Õß ·≈–°“√¬ÿμ°‘ “√«®‘ ¬— /°“√À¬ÿ¥

°“√«®‘ —¬°Õà π°”Àπ¥¢Õ߇√ËÕ◊ ß„¥ Ê °àÕπ°“√≈ß¡μ‘

Û-Ù.Ù §®¡. ¡’«‘∏°’ “√√—∫√Õß√“¬ß“π°“√ª√–™ÿ¡ WHO 2000, 6.1.3

WHO 2011, standard 9

WHO 2011, Annex 3

Û-ı °√–∫«π°“√≈ß¡μμ‘ —¥ ‘π

(§®¡. §«√¡«’ ∏‘ °’ “√ ”À√—∫°“√≈ß¡μ‘μ—¥ ‘π °√√¡°“√§«√¡ ’ «à π√à«¡„π°√–∫«π°“√)

Û-ı.Ò °“√≈ß¡μμ‘ ¥—  ‘π°√–∑”„π∑ªË’ √–™ÿ¡∑Ë¡’ Õ’ ߧªå √–™¡ÿ §√∫ ICH 3.2.3, WHO 2000, 7.3

WHO 2011, Annex 3

Û-ı.Ú ¡‡’ ©æ“–°√√¡°“√∑Ë¡’ ’ «à π√à«¡„π°“√μ¥—  π‘ ICH 3.2.4

WHO 2000, 7.5

WHO 2011, Annex 3

Û-ı.Û ¡’‡Õ° “√∑’Ë®”‡ªπì ∑Èß— À¡¥ ”À√—∫æ‘®“√≥“∑∫∑«π°Õà π°“√≈ß¡μμ‘ ¥—  π‘ WHO 2000, 7.4

WHO 2011, Annex 3

Û-ı.Ù §®¡. ¡°’ “√°”À𥫑∏’°“√‰«â≈«à ßÀπ“â ∑Ë’®–„À≥§â ”μ—¥ π‘ ‡™àπ ©π— ∑“¡μ‘ À√Õ◊ ≈ߧ–·ππ WHO 2000, 7.6

WHO 2011, Annex 3

Û-ı.ı §®¡. „À§â «“¡¡Ëπ— „®«à“°√√¡°“√∑Ë’¡’º≈ª√–‚¬™π¢å —¥·¬âß°—∫‚§√ß°“√«‘®¬— ‰¡¡à  ’ «à π WHO 2000, 7.1

„π°“√≈ß¡μμ‘ ¥—  π‘ WHO 2011, Annex 3

Û-ı.ˆ °√√¡°“√¡‡’ «≈“‡æ’¬ßæÕ∑’Ë„™æâ ‘®“√≥“∑∫∑«π·≈–¡’°“√Õ¿ª‘ √“¬°Õà π∑”°“√≈ß¡μ‘μ—¥ π‘ WHO 2000, 7.2

WHO 2011, Annex 3

Û-ı.˜ ‡¡Ë◊Õ°“√μ¥—  ‘π‡ªìπ·∫∫®–æ‘®“√≥“∑∫∑«π„À¡à ¡°’ “√√–∫ªÿ √–‡¥πÁ ∑Ë’„À·â °â‰¢Õ¬à“ß™—¥‡®π WHO 2000, 7.8

WHO 2011, Annex 3

Û-ı.¯ °“√μ—¥ π‘ ‰¡à„À⧫“¡‡ÀÁπ™Õ∫/‰¡√à ∫— √Õß‚§√ß°“√ ¡°’ “√· ¥ß‡Àμÿº≈Õ¬à“ß™—¥‡®π WHO 2000, 7.9

WHO 2011, Annex 3

¡“μ√∞“π∑Ë’ Ù - «‘∏’°“√ªØ‘∫—μÀ‘ ≈ß— „À⧫“¡‡ÀÁπ™Õ∫

(§®¡. §«√μ‘¥μàÕ·®âߺ≈°“√æ‘®“√≥“μ¥—  ‘π„Àºâ Ÿ«â ‘®¬— ∑√“∫Õ¬“à ߇欒 ßæÕ·≈–¡’ª√– ∑‘ ∏‘¿“æ)

Ù-Ò °“√·®âߺ≈°“√殑 “√≥“μ—¥ ‘π

(§®¡. ¡’«‘∂’∑“ß∑¡Ë’ ª’ √– ∑‘ ∏¿‘ “æ·≈–∑π— μàÕ‡«≈“„π°“√쥑 μàÕ·®ßâ º≈°“√μ¥—  π‘ æ√Õâ ¡‡Àμºÿ ≈∑Ë’™¥— ‡®π)

Ù-Ò.Ò ·®âߺ≈ √ªÿ °“√殑 “√≥“μ¥—  ‘π‡ªìπ≈“¬≈—°…≥åÕ—°…√„Àºâ Ÿ¬â Ëπ◊ ¿“¬„π ÒÙ «π— À√Õ◊ √–∫ÿ WHO 2000, 8

21 ¿“¬„π°Ë’«—π WHO 2011, Annex 3

22 Ù-Ò.Ú „π®¥À¡“¬·®âߺ≈°“√殑 “√≥“μ¥—  ‘π ¡’°“√√–∫ÿª√–‡¥πÁ ∑’˺Ÿâ«‘®¬— μâÕߪ√—∫ª√ßÿ °àÕπ‰¥â√—∫ ICH 3.3.9

§«“¡‡ÀπÁ ™Õ∫/√∫— √Õß WHO 2000, 7.4

WHO 2011, Annex 3

Ù-Ò.Û „π®¥À¡“¬·®âߺ≈°“√æ‘®“√≥“μ¥—  π‘ ¡’™ËÕ◊ ‚§√ß°“√«®‘ ¬— ∑Ëæ’ ‘®“√≥“∑∫∑«π WHO 2000, 8.1

WHO 2011, Annex 3

Ù-Ò.Ù „π®¥À¡“¬·®ßâ º≈°“√æ‘®“√≥“μ—¥ π‘ ¡’À¡“¬‡≈¢¢Õ߇հ “√∑æË’ ‘®“√≥“√«¡∑—È߇հ “√ WHO 2000, 8.2

„À¢â âÕ¡Ÿ≈·≈–¢Õ§«“¡¬‘π¬Õ¡ WHO 2011, Annex 3

Ù-Ò.ı „π®¥À¡“¬·®ßâ º≈°“√æ‘®“√≥“μ—¥ π‘ ¡™’ Õ◊Ë ·≈–μ”·Àπßà ¢Õߺ¬Ÿâ πË◊ ‚§√ß°“√ WHO 2000, 8.4

WHO 2011, Annex 3

Ù-Ò.ˆ „π®¥À¡“¬·®ßâ º≈°“√æ‘®“√≥“μ—¥ π‘ ¡«’ —π∑Ë·’ ≈– ∂“π∑∑’Ë æ’Ë ®‘ “√≥“μ—¥ ‘π WHO 2000, 8.6

WHO 2011, Annex 3

Ù-Ò.˜ „π®¥À¡“¬·®ßâ º≈°“√æ‘®“√≥“μ—¥ ‘π ¡’√“¬π“¡¢Õߧ≥–°√√¡°“√∑≈’Ë ß¡μ‘ WHO 2000, 8.7

WHO 2011, Annex 3

Ù-Ò.¯ „π®¥À¡“¬·®ßâ º≈°“√殑 “√≥“μ¥—  ‘π ¡¢’ âÕ§«“¡√–∫§ÿ «“¡√∫— º‘¥™Õ∫¢ÕߺŸâ¬◊Ëπ ICH 3.3.6, 3.3.7

WHO 2000, 8.11

WHO 2011, Annex 3

Ù-Ò.˘ „π®¥À¡“¬·®âߺ≈°“√æ‘®“√≥“μ¥—  ‘π ¡°’ “√≈ßπ“¡¢Õߪ√–∏“π (À√Õ◊ ºâ¡Ÿ Õ’ ”π“®Àπâ“∑’)Ë WHO 2000, 8.14

·≈–≈ß«π— ∑Ë’ WHO 2011, Annex 3

Ù-Ò.Ò §®¡. ·®ßâ º«Ÿâ ‘®¬— ‡°’¬Ë «°∫— °”Àπ¥°“√/·ºπß“π°“√殑 “√≥“∑∫∑«πÕ¬“à ßμÕà ‡πÕË◊ ß WHO 2000, 8.12

WHO 2011, Annex 3

Ù-Ò.ÒÒ „π®¥À¡“¬¢Õß §®¡. ∑·Ë’ ®ßâ °“√√–ß∫— À√◊Õ¬μÿ °‘ “√«‘®—¬°àÕπ°”Àπ¥ ¡’°“√√–∫ÿ‡Àμºÿ ≈ ICH 3.3.9
Õ¬à“ß™¥— ‡®π∂÷ß°“√√–ß∫— À√Õ◊ ¬μÿ °‘ “√«®‘ —¬°àÕπ°”Àπ¥ WHO 2000, 9.5
WHO 2011, Annex 3
Ù-Ò.ÒÚ ‡Õ° “√°“√≈ß¡μ‚‘ ¥¬ §®¡. ¡°’ “√√–∫ÿÕ¬“à ß™¥— ‡®π«à“ºŸâ¬πË◊ ‚§√ß°“√ “¡“√∂쥑 μàÕ°∫— WHO 2000, 8.11
§®¡. ‰¥âÕ¬“à ߉√ WHO 2011, Annex 3

¡“μ√∞“π∑’Ë ı - °“√®¥— °“√‡Õ° “√·≈–°“√‡°∫Á √—°…“‡Õ° “√

(§®¡. ®—¥°“√‡Õ° “√·≈–®—¥‡°∫Á √—°…“Õ¬“à ߇ªπì √–∫∫„π√–¬–‡«≈“∑‡Ë’ À¡“– ¡)

ı-Ò.Ò §®¡. ¡·’ ≈–ªØ∫‘ —μ‘μ“¡«‘∏’¥”‡ππ‘ °“√∑°Ë’ ”Àπ¥‰«â‡ªπì ≈“¬≈—°…≥åÕ°— …√„π°“√‡°Á∫√°— …“ ICH 3.4

∫π— ∑÷°∑È—ßÀ¡¥√«¡∑—ßÈ ‡Õ° “√°“√μ‘¥μÕà ∑°ÿ ©∫—∫ WHO 2000, 10

WHO 2011, Annex 3

ı-Ò.Ú §®¡. ¡·’ ≈–ªØ∫‘ —μμ‘ “¡«∏‘ ’¥”‡π‘π°“√‡¢“â ∂ß÷ À√◊Õ‡√¬’ °¢âÕ¡Ÿ≈¢Õ߇հ “√μà“ßÊ ·ø¡Ñ À√Õ◊ ICH 3.4

‡Õ° “√∑ˇ’ °Á∫√—°…“‰«â WHO 2000, 10

WHO 2011, Annex 3

ı-Ò.Û §®¡. ¡°’ “√°”À𥫒∏°’ “√®¥— ‡°Á∫ °“√‡¢â“∂÷ß ·≈–°“√‡√’¬°¢âÕ¡≈Ÿ ®“°‡Õ° “√ ICH 3.4

WHO 2000, 2000, 10

WHO 2011, Annex 3

ı-Ò.Ù §®¡. ‡°∫Á √—°…“·øÑ¡À√Õ◊ ∞“π¢âÕ¡Ÿ≈∑’Ë ¡∫Ÿ√≥®å ”π«π Ò ™¥ÿ ¢Õß‚§√ß°“√«®‘ —¬·μ≈à –‡√◊ÕË ß WHO 2000, 10.7

23 WHO 2011, Annex 3

24 ı-Ò.ı §®¡. ªØ∫‘ μ— ‘μ“¡¢Õâ °”Àπ¥„À⇰∫Á √—°…“‡Õ° “√·≈–∫—π∑°÷ ‡ªìπ‡«≈“Õ¬à“ßπÕâ ¬ Û ªï ICH 3.4
À≈ß— ®“°°“√«‘®—¬‡ √Á® ¡∫Ÿ√≥å WHO 2000, 10
WHO 2011, Annex 3
ı-Ò.ˆ ‡Õ° “√·≈–∫π— ∑÷°μ“à ßÊ ∑’ˇ°¬’Ë «¢âÕß “¡“√∂μ√«® Õ∫‰¥â‚¥¬º¡Ÿâ Õ’ ”π“®Àπ“â ∑Ë’ ICH 3.4 WHO 2000, 10
ı-Ò.˜ §®¡. ®—¥‡°Á∫‡Õ° “√«∏‘ ’¥”‡π‘π°“√¡“μ√∞“π ·≈–¢Õâ °”Àπ¥„π°“√∑”Àπâ“∑∑Ë’ ÕË’ “»¬— WHO 2011, Annex 3
WHO 2000, 10.1
Õâ“ßՑ߉¥â WHO 2011, Annex 3
ı-Ò.¯ §®¡. ®¥— ‡°∫Á ‡Õ° “√ª√–«—μ‘·≈–º≈ß“π¢Õß°√√¡°“√∑°ÿ §π WHO 2000, 10.2
ı-Ò.˘ §®¡. ®¥— ‡°Á∫‡Õ° “√·π«∑“ß°“√¬πË◊ ‚§√ß°“√∑’Ë §®¡. ®—¥æ‘¡æ剫â WHO 2011, Annex 3
ı-Ò.Ò §®¡. ®—¥‡°Á∫√–‡∫’¬∫«“√–°“√ª√–™ÿ¡·≈–√“¬ß“π°“√ª√–™¡ÿ WHO 2000, 10.4
WHO 2011, Annex 3
ı-Ò.ÒÒ §®¡. ®¥— ∑” ”‡π“º≈°“√≈ß¡μ‘·≈–§”·π–π” À√Õ◊ ¢Õâ °”Àπ¥„¥Ê ∑·Ë’ ®ßâ ·°àºâ¬Ÿ Ëπ◊ ‚§√ß°“√ WHO 2000, 10.5, 10.6
WHO 2011, standard 9
ı-Ò.ÒÚ §®¡. ®¥— ‡°∫Á ‡Õ° “√∑—ßÈ À¡¥∑Ë’‰¥â√—∫√–À«“à ß°“√μ‘¥μ“¡‚§√ß°“√«®‘ ¬— WHO 2011, Annex 3
WHO 2000, 10.9
WHO 2011, standard 9
WHO 2011, Annex 3
WHO 2000, 10.10
WHO 2011, standard 9
WHO 2011, Annex 3

ı-Ò.ÒÛ §®¡. ®—¥‡°∫Á ‡Õ° “√·®ßâ °“√«®‘ —¬‡ √®Á  π‘È °“√√–ß∫— °Õà π°”Àπ¥ À√◊Õ¬ÿμ‘°“√«®‘ ¬— WHO 2000, 10.11
°Õà π°”Àπ¥ WHO 2011, standard 9
WHO 2011, Annex 3
ı-Ò.ÒÙ §®¡. ®—¥‡°∫Á ‡Õ° “√√“¬ß“π°“√«‘®¬— ‡ √®Á  ¡∫√Ÿ ≥å (√“¬ß“πμ“¡·∫∫øÕ√å¡) WHO 2000, 10.12
WHO 2011, standard 9
WHO 2011, Annex 3

25

Standards of Research

EthSictsanCdoamrdmsitotefeR(eSsReEarCc)h
Ethics Committee (SREC)

Standards of Research Ethics Committee (SREC) are standards for
ethical review practices of the Research Ethics Committee (REC).
The SREC prepared by the National Research Council of Thailand (NRCT)
is based on the WHO Operational Guidelines for Ethics Committee That
Review Biomedical Research, 2000 (Silver Book), Standards and Operational
Guidance for Ethics Review of Health-Related Research with Human
Participants, WHO 2011, international standards used in SIDCER recognition
program (SIDCER stands for The Strategic Initiative for Developing Capacity
of Ethical Review) and the Good Clinical Practice Guideline (ICH GCP
Guideline, 1996). The NRCT will use this SREC in the National Accreditation
System of Thailand (NECAST)

Objectives of the SREC

1. To provide guidance on developing the REC and standards for
ethical review practices.

2. To be used in the NECAST for evaluation and accreditation the
REC.

SREC consists of 5 standards, including

Standard I - Structure and Composition of the REC
Standard II - Adherence to Specific Policies
Standard III - Review Procedures
Standard IV - After Review Procedures
Standard V - Documentation and Archiving
26

Standard I-STRUCTURE AND COMPOSITION OF REC

(structure, composition and skills of RECs and staff are appropriate to the amount and nature of research reviewed)

I-1 MEMBERSHIP REQUIREMENTS (at least 5 members, gender balance, experience, non scientific

and affiliated members and terms and conditions of appointment)

I-1.1 RECs have at least 5 members ICH 3.2.1

I-1.2 The members contain a diversity of gender WHO 2000, 4

WHO 2011, standard 2

I-1.3 RECs have at least one non affiliated member ICH 3.2.1

WHO 2000, 4

WHO 2011, standard 2

I-1.4 REC membership contains non-scientific member or lay person ICH 3.2.1

WHO 2000, 4

WHO 2011, standard 2

I-1.5 REC membership consists of members with appropriate expertise for the ICH 3.2.1

research reviewed WHO 2000, 4

WHO 2011, standard 2

I-1.6 RECs describe the party responsible for appointing members WHO 2000, 4.1.1

WHO 2011, standard 9

WHO 2011, Annex 3

27 I-1.7 REC members possess the required experience, knowledge, skill and WHO 2000, 4

relevant abilities to perform their duties. WHO 2011, standard 2

28 I-1.8 RECs policy and procedures describe the selection process of its members. ICH 3.3.1

WHO 2000, 4.1.2

WHO 2011, standard 9

I-1.9 REC terms describe the duration of appointment for its members. WHO 2000, 4.2.1

WHO 2011, standard 9

WHO 2011, Annex 3

I-1.10 REC terms describe the policy for the renewal of appointment for its members. WHO 2000, 4.2.2

WHO 2011, Annex 3

I-1.11 REC terms describe the disqualification procedure of its members. WHO 2000, 4.2.3

WHO 2011, standard 9

WHO 2011, Annex 3

I-1.12 REC terms describe the resignation procedure for its members. WHO 2000, 4.2.4

WHO 2011, Annex 3

I-1.13 REC terms describe the replacement procedures for its members. WHO 2000, 4.2.5

WHO 2011, Annex 3

I-1.14 RECs maintain a list of all its members with their current CV. ICH 3.2.1

WHO 2011, Annex 3

I-1.15 REC members sign a confidentiality agreement. WHO 2000, 4.3.3

WHO 2011, Annex 3

I-1.16 REC members are willing to publicize full name, profession and affiliation. ICH 3.4

WHO 2000, 4.3.1
WHO 2011, Annex 3
I-2 ADMINISTRATIVE REQUIREMENTS.
(Adequate number of administrators to oversee RECs activities, have documentation of the functions and
activities of staff and their terms and conditions of appointment)

I-2.1 RECs have sufficient staff (full-time or part-time) to meet its functions and WHO 2000, 4.4

responsibilities. WHO 2011, standard 3

WHO 2011, Annex 2

I-2.2 RECs have a description of requirements for holding offices. WHO 2000, 4.4
I-2.3 RECs policy describes the terms and conditions of each office, WHO 2011, standard 3
I-2.4 RECs have documentation explaining the duties, obligations and WHO 2011, Annex 2
WHO 2000, 4.4
WHO 2011, standard 9
WHO 2011, Annex 2
WHO 2000, 4.4

responsibilities of its offices. (e.g. agenda, minutes, notification of decisions). WHO 2011, standard 9

Clear procedures for selecting or appointing officers should be established. WHO 2011, Annex 2

I-2.5 RECs have an office space. WHO 2000, 4.4

29 WHO 2011, standard 3

30 I-2.6 RECs have the necessary equipments to run the office. WHO 2000, 4

WHO 2011, standard 3

WHO 2011, Annex 2

I-2.7 RECs have available budget to meet its functions and responsibilities. WHO 2011, standard 3

WHO 2011, Annex 2

I-2.8 RECs document reimbursement for work and expenses and is this made WHO 2000, 4.3.2

available to the public upon request. WHO 2011, standard 3

I-3 TRAINING OF REC MEMBERS

(RECs need to state and observe the provisions available for its members to receive introductory and

continuous education)

I-3.1 REC membersû condition of appointment states the provisions for them to WHO 2000, 4.7

receive introductory and ongoing training. WHO 2011, standard 5

I-3.2 REC members receive an introductory training. WHO 2000, 4.7

WHO 2011, standard 5

I-3.3 REC members are continually trained to enhance their capacity for ethical WHO 2000, 4.7

review. WHO 2011, standard 5

I-3.4 RECs review and document trainings obtained by their members and staff. WHO 2000, 4.7

WHO 2011, standard 5

I-4 MANAGEMENT OF CONFLICTS WHO 2000, 4.1.3
(REC should have a policy to address conflicts of interests) WHO 2011, standard 4
WHO 2011, Annex 3
I-4.1 RECs have a process of managing, minimizing or eliminating conflicts of
interest.

Standard II-ADHERENCE TO SPECIFIC POLICIES

(RECs to have appropriate management and operational procedures for optimal and systematic conduct of ethical
review)

II-1 REC MANAGEMENT

(RECs to have terms of reference)

II-1.1 RECs have terms of reference which includes its scope, objectives, WHO 2000, 4

activities, organization and management. WHO 2011, standard 2

WHO 2011, Annex 2, 3

II-2 AVAILABILITY OF SOP

(RECs should have an SOP that covers its function and activities which they comply with)

II-2.1 RECs have written SOP. ICH 3.2.2, WHO 2000, 4

WHO 2011, standard 9

31 WHO 2011, Annex 3

32 II-2.2 The SOP covers all functions and reviews undertaken by RECs. ICH 3.2.2, WHO 2000, 4
II-2.3 RECs comply with the written SOP. WHO 2011, standard 9
II-2.4 The SOP is reviewed and revised as necessary. WHO 2011, Annex 3
II-2.5 RECs make their SOP publicly available. ICH 3.2.2,WHO 2000,4
WHO 2011, standard 9
WHO 2011, Annex 3
WHO 2011, standard 9
WHO 2011, Annex 3
ICH 3.2.2
WHO 2011, Annex 3

II-3 SUBMISSION GUIDELINES AND PROCESS
(RECs should have a submission guideline including its requirements and forms)

II-3.1 RECs have any guidance on how to submit protocols. WHO 5.1
II-3.2 RECs have an application form. WHO 2011, Annex 3
II-3.3 RECs indicate the format for submission. WHO 2000, 5.2.2
II-3.4 RECs indicate the number of copies of application to be submitted. WHO 2011, Annex 3
WHO 2000, 5.2.3
WHO 2011, Annex 3
WHO 2000, 5.2.6
WHO 2011, Annex 3

II-3.5 RECs indicate the application procedures for protocol amendments and WHO 2000, 5.2.2

continuing review. WHO 2011, Annex 3

II-3.6 RECs have an informed consent guidance/template which it made available WHO 2011, Annex 3

to investigators to help with the preparation of the document.

II-3.7 RECs have a registration procedure (tracking system) for the applications WHO 2011, Annex 3

made for review.

II-3.8 RECs specify the name and address of ECs secretariat to whom the WHO 2000, 5.2.1

application should be submitted. WHO 2011, Annex 3

II-3.9 RECs have means of acknowledging applications made to them. WHO 2000, 5.2.8

WHO 2011, Annex 3

II-3.10 RECs communicate the incompleteness of an application. WHO 2000, 5.2.8

WHO 2011, Annex 3

II-3.11 RECs indicate fee structure, if any, for reviewing an application. WHO 2000, 5.2.11

WHO 2011, Annex 3

II-3.12 RECs indicate that application forms should be signed and dated. WHO 2000, 5.3.1

WHO 2011, Annex 3

II-3.13 RECs request that protocol be submitted together with supporting documents ICH 3.1.2

and annexes. WHO 2000, 5.3.2

WHO 2011, Annex 3

33 II-3.14 RECs request submission of the project summary and diagrammatic WHO 2000, 5.3.3

representative (flow chart) of the protocol. WHO 2011, Annex 3

34 II-3.15 RECs request submission of a description of the ethical considerations WHO 2000, 5.3.4

involved in the research. WHO 2011, Annex 3

II-3.16 RECs request submission of case report forms, diary cards and other WHO 2000, 5.3.5

questionnaires intended for research participants. WHO 2011, Annex 3

II-3.17 When a research involves a study product, RECs request submission an ICH 3.1.2

adequate summary of the study product. WHO 2000, 5.3.6

II-3.18 RECs request submission of the investigators CV. ICH 3.1.2

WHO 2000, 5.3.7

WHO 2011, Annex 3

II-3.19 RECs request submission of the materials to be used for the recruitment ICH 3.1.2

of potential participants. WHO 2000, 5.3.8

WHO 2011, Annex 3

II-3.20 RECs request submission of the informed consent form. ICH 3.1.2, WHO 5.3.10

WHO 2011, Annex 3

II-3.21 RECs request submission of a statement describing any compensation for ICH 3.1.2,

study participants. WHO 2000, 5.3.12,

WHO 2011, Annex 3

II-3.22 RECs request submission of a description of the arrangements for indemnity WHO 2000, 5.3.13

if applicable. WHO 2011, Annex 3

II-3.23 RECs request submission of a description of the arrangements for insurance WHO 2000, 5.3.14

coverage if applicable.

II-3.24 RECs request submission of a statement of agreement to comply with WHO 2000, 5.3.15
ethical principles set out in relevant guidelines. WHO 2011, Annex 3
WHO 2000, 5.3.16
II-3.25 RECs request submission of all significant previous decisions by ECs or WHO 2011, Annex 3
regulatory authorities for the proposed study.

II-4 MEETING REQUIREMENTS

(RECs should have documented meeting requirements which they comply with, quorum and professional

requirements)

II-4.1 RECs meet regularly on scheduled date announced in advance. ICH 3.2.2,

WHO 2000, 6.1

WHO 2011, Annex 3

II-4.2 RECs form a quorum before holding its meeting. WHO 2000, 4.5

WHO 2011, Annex 3

II-4.3 Quorum requirements provide that more than half of the members but at WHO 2011, standard 2

least five people, including at least one lay member and one non-affiliated WHO 2011, Annex 3

member be part of a quorum for each of its meeting .

II-4.4 RECs require that meetings should be minuted and there should be an WHO 2000, 6.1.3

approval procedure for the minutes. WHO 2011, Annex 3

35

36 Standard III-COMPLETENESS OF ITS REVIEW PROCESS

(REC review protocols and its supporting documents in a timely fashion according to an established procedure to
protect the interest of research participants)

III-1 REVIEW PROCESS

(enough time for protocol review, REC to have documented and detailed review process which is

complied with)

III-1.1 RECs follow the operating procedure for review. ICH 3.3, WHO 2000, 6

WHO 2011, Annex 3

III-1.2 RECs review protocols and all relevant documents within a reasonable time ICH 3.1.2

frame. WHO 2000, 6.1.2

WHO 2011, Annex 3

III-1.3 RECs have an established procedure for expedited review. ICH 3.3.5

WHO 2000, 6

WHO 2011, Annex 3

III-1.4 RECs indicate the nature of the application, amendments, continuing review ICH 3.3.5

and other considerations that will be eligible for expedited review. WHO 2000, 6.3.1

WHO 2011, Annex 3

III-1.5 RECs have policies and procedures that describe the process used to ICH 3.3.5

evaluate whether research reviewed by the expedited procedures meets the WHO 2000, 6.3.3

criteria for review. WHO 2011, Annex 3

III-1.6 RECs have an established procedure for full board review. WHO 2000, 6.2

WHO 2011, Annex 3

III-1.7 RECs have an established process for obtaining additional expertise when ICH 3.3.6

reviewing specific protocols. WHO 2000, 4.6

WHO 2011, standard 2

WHO 2011, Annex 3

III-1.8 RECs have terms of reference for independent consultants. WHO 2000, 4.6

WHO 2011, standard 2

WHO 2011, Annex 3

III-1.9 RECs have an established process for inviting applicants/investigators to ICH 3.2.5

elaborate on specific issues when applicable. WHO 2011, standard 6

WHO 2011, Annex 3

III-2 ELEMENTS OF REVIEW

(RECs to have a policy and procedure for review, elements reviewed should include the scientific design

and conduct and ethics)

III-2.1 RECs have a policy and procedure for reviewing protocols. WHO 2000, 6.2

WHO 2011, standard 7

WHO 2011, Annex 3

III-2.2 RECs review the scientific design and conduct of the study. WHO 2000, 6.2.1

37 WHO 2011, standard 7

WHO 2011, Annex 3

38 III-2.3 RECs review the justification for the use of control arms. WHO 2000, 6.2.1.3
III-2.4 WHO 2011, standard 7
III-2.5 RECs review the criteria for prematurely withdrawing research participants. WHO 2000, 6.2.1.4
III-2.6 WHO 2011, standard 7
RECs review the criteria for suspending or terminating the research. WHO 2000, 6.2.1.5
III-2.7 RECs have justification of predictable risks and inconveniences weighed WHO 2000, 6.2.1.2
against the anticipated benefits for the research participants and concerned WHO 2011, standard 7
III-2.8 communities.
III-2.9 RECs review the adequacy of provisions made for monitoring and auditing WHO 2000, 6.2.1.6
III-2.10 the conduct of the research, including the constitution of a data safety and WHO 2011, Annex 3
III-2.11 monitoring board (DSMB). WHO 2011, standard 9
III-2.12 RECs review the manner in which the results of the research will be WHO 2000, 6.2.1.8
reported and published.
RECs review whether the risk posed to research subjects is reasonable in WHO 2000, 6.2.1.2
relation to its anticipated benefits. WHO 2011, standard 8
RECs follow the established procedure for determining if potential risks ICH 3.1.6
posed to the vulnerable population are acceptable. WHO 2011, standard 7
RECs review the description of the informed consent process and the WHO 2000, 6.2.5.1
identification of those responsible for obtaining it. WHO 2011, standard 7
RECs review the informed consent focusing on measures to improve WHO 2000, 6.2.5.2
participant understanding and voluntary decision making. WHO 2011, standard 7

III-2.13 RECs review justification to include research individual that cannot consent ICH 3.1.6
and account of the arrangements for obtaining consent. WHO 2000, 6.2.5.3
III-2.14 WHO 2011, standard 7
III-2.15 RECs have and follow the established procedure to determine if the ICH 3.1.5
III-2.16 vulnerable subjects are protected in the consent process. WHO 2011, standard 7
RECs have and follow the established procedure in reviewing the consent ICH 3.1.2
III-2.17 process in emergency situation in research protocol. WHO 2011, standard 7
RECs review the information assuring research participants that they will WHO 2000, 6.2.5.4
III-2.18 receive available information during the course of the research relevant to WHO 2011, standard 7
their participation.
III-2.19 RECs review the provisions made by researchers for receiving and WHO 2000, 6.2.5.5
III-2.20 responding to queries and complaints from participants or representatives WHO 2011, standard 6
during the course of the research.
39 RECs review the suitability of the investigators qualifications and experience ICH 3.1.3
for the proposed study. WHO 2000, 6.2.3.1
WHO 2011, standard 7, 10
RECs review any plans to withdraw or withhold standard therapies for the WHO 2000, 6.2.3.2
purpose of the research and the justification for such action. WHO 2011, standard 7
RECs review the steps to be taken if research participants voluntarily WHO 2000, 6.2.3.5
withdraw during the course of the research. WHO 2011, standard 7

40 III-2.21 RECs have and follow an established procedure in evaluating the protection WHO 2000, 6.2.4
of privacy and confidentiality of the research participants during and after WHO 2011, standard 7
III-2.22 the completion of the research.
III-2.23 RECs have and follow established procedure to determine if the vulnerable ICH 3.1.6
III-2.24 subjects are properly protected. WHO 2011, standard 6
III-2.25 RECs have and follow procedures of determining whether the method WHO 2000, 6.2.2
used to recruit the research subjects is acceptable or not. WHO 2011, standard 7
III-2.26 RECs review the description of the plan to make the study product WHO 2000, 6.2.3.8
III-2.27 RECs have and follow established procedure for evaluating the inclusion WHO 2000,
III-2.28 and exclusion criteria. 6.2.2.4, 6.2.2.5
WHO 2011, standard 7
III-2.29 RECs have and follow established procedure for evaluating the characteristics WHO 2000, 6.2.2.1
of the population from which participants are drawn.
RECs have methods of ensuring that additional safe guards are included to ICH 3.1.6, 3.1.7
protect the rights and welfare in research involving vulnerable populations. WHO 2011, standard 7
RECs review payment for research participants to determine if it will unduly ICH 3.1.8
influence them to participate in research. WHO 2000, 6.2.3.9
WHO 2011, standard 7
RECs review compensation for research participants to determine if it they ICH 3.1.9, WHO 2000,
adequately compensated for injury. 6.2.3.10, 6.2.3.11
WHO 2011, standard 7

III-2.30 RECs review the standard of care and other post trial benefits offered to WHO 2000, 6.2.3.3
III-2.31
III-2.32 participants. WHO 2011, Annex 2, 3
III-2.33
III-2.34 RECs review the impact and relevance of research on the local community WHO 2000, 6.2.6.1
III-2.35
III-2.36 from which the research participants are drawn. WHO 2011, Annex 2

III-2.37 RECs review the steps taken to consult with the concerned communities WHO 2000, 6.2.6.2

III-3 during the course of the designing of the research. WHO 2011, Annex 2

RECs review the influence of the community on the consent of individuals. WHO 2000, 6.2.6.3

WHO 2011, Annex 2

RECs review proposed community consultation during the course of the WHO 2000, 6.2.6.4

research. WHO 2011, Annex 2

RECs review the extent to which research contributes to capacity building WHO 2000, 6.2.6.5

within the community. WHO 2011, Annex 2

RECs review a description of the availability and affordability of any WHO 2000, 6.2.6.6

successful study product to the concerned communities following the WHO 2011, standard 10

research.

RECs review the rights to give subjects additional information when the WHO 2000, 6.2.5.4

additional information would add meaningfully to the protection of the rights, WHO 2011, standard 10

safety and/or well-being of the subjects. WHO 2011, Annex 2, 3

AFTER PROTOCOL APPROVAL

41 (REC to document and follow procedures of reviews of amendments, continuing, SAE reports)

42 III-3.1 RECs have continuing review. ICH 3.1.4, 3.3.3

WHO 2000, 9

WHO 2011, Annex 2, 3

III-3.2 RECs have and follow an established procedure for determining the frequency ICH 3.1.4

of continuing review. WHO 2000, 9.2

WHO 2011, Annex 2, 3

III-3.3 RECs have and follow an established procedure for handling modification ICH 3.2.7

(amendments) of research protocol. WHO 2000, 9.3

WHO 2011, Annex 2, 3

III-3.4 RECs have documents required for continuous review and is this list WHO 2000, 8.11

made available to investigators. WHO 2011, Annex 3

III-3.5 RECs consider the submitted relevant information and documents in its WHO 2000, 9.3

continuing review. WHO 2011, Annex 2

III-3.6 RECs have and follow an established procedure to notify investigators ICH 3.1.4

when it will conduct a continuing review. WHO 2000, 9.4

WHO 2011, standard 10

WHO 2011, Annex 2, 3

III-3.7 Does REC have and follows policies and procedures for suspending or WHO 2000, 9.4

terminating previously approved research if need be based on findings in WHO 2011, standard 10

monitoring or continuing review.

III-3.8 RECs require the investigator to notify RECs in writing of the reasons and WHO 2000, 9.5
III-3.9 a summary of the research results when applicant prematurely suspend or WHO 2011, standard 10
III-3.10 terminate the study.
III-3.11 RECs do a follow up review when serious and unexpected adverse events WHO 2000, 9.3 b
III-3.12 occur as a result of the conduct of the study or study (test) product and WHO 2011, standard 10
III-3.13 necessary steps need to be instituted to protect participants.
III-3.14 RECs specify that no deviations from, or changes of, the protocol should be ICH 3.3.7
initiated without prior written IRB/IEC approval/favorable oRpinion of an
appropriate amendment. ICH 3.3.8
RECs specify that the investigator should promptly report to the IRB/IEC WHO 2000, 9.3 c
any deviations from, or changes of, the protocol to eliminate immediate WHO 2011, standard 10
hazards to the trial subjects. ICH 3.3.8
RECs specify that the investigator should promptly report to the REC WHO 2000, 9.3 c
changes increasing the risk to subjects and/or affecting significantly the WHO 2011, standard 10
conduct of the trial. ICH 3.3.8
RECs specify that the investigator should promptly report to the REC all WHO 2011, Annex 3
adverse drug reactions (ADRs) that are both serious and unexpected. ICH 3.3.8
RECs specify that the investigator should promptly report to the IRB/IEC WHO 2011, standard 10
any new information that may affect adversely the safety of the subjects or
43 the conduct of the trial.