23.09.29 () 16:19

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"̿ CDISC , ƴ ʼ"
̼ 2022-12-01 06:00:20
"̿ CDISC , ƴ ʼ"
̼ 2022-12-01 06:00:20
[DPͺ]ȯ Ŭ ǥ

ؿܼ ӻ󡤺ӻ ڷ CDISC ǹȭ

CDISC ǥ ɻ 㰡 ż... Ŭ, CDISCü ο

  ȯ Ŭ ǥ.

[ϸ=̼ ] "۷ι ̿ CDISC(Clinical Data Interchange Standard Consortium) ƴ ʼ."

ؿ ӻ̳ ӻ ڷ ӻǥ(CDISC) ǹ ǰϰ ִ. ̱(FDA) 2017 CDISC ǥ ǹȭ ߰ Ϻ(PMDA), ߱(NMPA)  ̸ ִ. (EMA) CDISC ǥ ǰϰ ִ.

ݸ CDISC Ȱ뵵 . ľó 4 Ǿǰ ӻ󡤺ӻ ڷ ǥ(CDISC) ٰŸ CDISC ڷḦ ϰ ̸ ɻ ִ Ȯε ʰ ִ.

FDA, EMA ڷγ żϰ Ȯ ž 㰡 ʿ伺 CDISC ͸ ϰ Ȳ̴. ؿ ó CDISC ǥ ԰ ѱ ž CDISC ε ʿϴٴ ǰ .

ȯ Ŭ ǥ CDISC ǹȭ ʿ伺 ô. ŬǴ CDISC ӻ-ӻ ÷ '޵ũ' ̴. CDISC ü ο ִٰ 򰡹޴´.

Ʒ Ϲ ϴ

CDISC ̻ ߻ ִ ۿ. ǻ ַ ҰŹѴ.

ũ ΰ. ù° CDISC ǥ ̵ FDA ż ɻ/㰡 ƴٴ ̴.

FDA ؿ eCTD(ڱ, Electronic Common Technical Document) ڹ CDISC ͸ ؾѴ. FDA ڵ/ ϰ м ֵ ü CDISC ý ϰ ִ.

̸ ȿ ɻ/㰡 ϰ ù° ż ɻü踦 ߴ. Ư ڷγ ȭ İ ӻ ο FDA CDISC .

ľó żӽɻü踦 ֱٿ ߴ. ٸ Ǵ ǥ ٸ ɻڰ ŷڼ ü ϰ мؾ ϴ FDA ؼ ż ɻ簡 ̴.

ι° FDA ž ο ڷ CDISC ǥ Ʈϰ CDISC ̵ ̷ ƴٴ ̴.

κ FDA 3 ڰмڷ(STR) ̴. ڷ 3 ̴. FDA ڷ 䱸  . FDA CDISC ȸ 2017 ھ๰ STR ̿ CDISC ǥ ̵带 κ ڷ , ڷ ã ־.

ݸ κ Ǿǰ 㰡 STR ڷᰡ ǹȭƴ. 츮 FDA CDISC ־ٸ κ ¿ ߺ ó ̴.

ŬǴ CDISC ӻ-ӻ հ ÷ ޵ũ ̴. ٸ CDISC ü

ŬǴ ʷ CDISC ӻӻRWD žళ ֱ ÷ '޵ũ(Medilake)' ϰ ִ. Ÿ ؿ ӻ Ǵ ӻ о߷ ÷ ŬǴ ž μ ֱ ̿ /м ϴ.

AI ӻ/ӻ ڵȭ ÷ Ѵ. ӻ/ӻ迡 CDISC Ͼ, ϴ. /CRO 忡 ð ӻ غ ϰ // ŷڼ ־ ϸ 䱸Ѵ. ŬǴ ̸ ִ.

޵ũ ÷ ӻ/ӻ迡 GAMP 5 ħ FDA 21 Part 11 䱸ϴ ϸ鼭 CDISC / α׷ ۾ ʿ ʴ´. ̸ ӻ迡 ߿ eCRF żϰ ȿ ִ.

ӻ ܰ躰 ̰ ְ eCRF ҿǴ 6~12 Ⱓ ޵ũ ϸ 1~2ַ پ. 80% ҿ Ⱓ ִ. Ŭ MediLake CTMS QCD(Quality, Cost, Delivery) 鿡 ǰ ϴ. ٸ ý۰ ȣ ȯ ȯ տ ࿡ ϴ.

޵ũ Ȳ ǥε ִ

ӻ о ֿ ޴. ӻ() ְ ѱȭп μ 򰡿(KIT) ̸ ѱȭս迬 / °踦 ϰ ִ.

ü ӻCRO ̿彺, Ϳ° SEND ̸ ̸޵, ڳؽƮ, ť ̿ ü 10 40 ž๰ CDISC SEND 񽺸 ϰ ִ.

ӻ о ֿ ü. ӻCRO ְ ü ̱۷ιĸ(LSK Global PS) CDISC ӻ 񽺸 ϰ ִ. õб 溴, ϴб, б ź ӻ󿬱 CDISC ӻ󿬱÷ ̴.

ؿܴ FDA ľó Covid-19 ġ ӻ2 ϰ ִ εCRO syncorp health 񽺸 ϰ ε CDISC 񽺸 Ȯ ̴. ޵ũ GAMP5 FDA 21 CFR Part 11 EMA Annex 11 ޾Ҵ.

ؿó CDISC ǹȭ ʿ δ. Ŭ ǥ ִٸ

ŬǴ ʷ CDISC ӻ-ӻ-RWD žళ ֱ ÷ ǥ ϰ ִ. ̸ GLP, CRO, /̿ ž BI, AI Ͻ ޲۴. ž/̿ ȯ ô , CRO, ڵ鿡 ȿ ɷ° ο ġ â ϵ ϰڴ.
̼ (wiviwivi@dailypharm.com) ٸ
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  • ̽
  • Ʈ
  • 2
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/home/dailypharm/issueData2017/
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͸ǰ | Ǹǰ߾ Ģ
ݱ

Ǹ ͸ , Ǹ ̸ ̵ ˴ϴ. ͸ ʸ ϸ, ͸ մϴ.

ڹ(-ڴϾ-ʱ ) ˵ ϸ ȸ Խ ⡯ ĺ Ʈ ׻ ֻܿ ˴ϴ. ο ø Ϲȸ Խ ĺ ڴϾ ȸ ϴܿ ǽð ˴ϴ.

뺸 ϰ ̵ ̿ Ǵ ֽϴ.

  • ۱ǡΰݱ Ÿ Ǹ ħϴ

    α׷ ϰ , ȳϴ Խù

    Ÿ Ǵ 3 ۱ Ÿ Ǹ ħ Խù

  • ٰ 桤 Ѽϴ Խù

    Ư ̿ ο ν 弳

    Ư 븳 ϴ

    Ȯ ȵ ҹ Ű

    弳 , Ӿ

    Ź, ɿ ˵Ǵ ( û )

    Ư ̳ ü ϴ

    Ư ѼϿ ش ûϴ

    Ư (ֹεϹȣ, ȭ, ּ ) Խϴ

    Ÿ ID Ȥ г ϴ

  • Խ Ư ѵǴ

    ʴ

    翡 ߺ

    κ Ͽ ݺ ϴ 쵵

    Խù,

    Ե Խù

    Խù б

  • û ִ

  • Ÿ

    ʿ伺 ̸

    Ÿ ˵Ǵ 縦

    Ÿ  ڰ ʿϴٰ ǴܵǴ

  • Ȯ

    ۱ڷκ , , ϴ

    Ÿ ʻ ħϰų ϴ

    翡 ̿ (Ÿ ID, йȣ )

  • ̻ Ϻ ׿ ̿ 縦 , Ρ ó ֽϴ.

    õ ̴ ҹ Ǵܵǰų ϸ 񽺿 ٶ ʴٰ ǴܵǴ ġ ϰڽϴ.

    رŸ ϸ ڿ ֽʽÿ. ּҴ dailypharm@dailypharm.comԴϴ.

ֽż ݴ
  • 2022.12.07 00:23:04 |

    CDISC ñմϴ.

    0 0 0
  • 2022.12.01 08:34:36 |

    . ° ȭ . 嵵 ϳ.

    0 3 0
ٺ Ϲݾ ǸŰ (2023 09)
౹ 32
ǰ ְ
ڶ(20) 6,500 6,500 0 6,500
ѽŻ÷(10) 3,500 2,500 1,000 2,952
޾(100) 22,000 22,000 0 22,000
Ʒγΰ(100) 30,000 27,000 3,000 28,909
īɾ(10g) 7,000 6,000 1,000 6,516
Ľõ򿬰(5g) 5,000 4,000 1,000 4,522
Ź(4) 4,000 3,500 500 3,964
λ絹÷(100) 35,000 30,000 5,000 32,315
̰źĸ(100) 35,000 32,000 3,000 34,406
(10) 6,000 4,500 1,500 4,923
Ժ(10) 4,000 3,000 1,000 3,523
ڱ׸(20) 5,000 4,000 1,000 4,531
ť(10) 3,000 2,500 500 2,909
Ȱť(1) 1,200 900 300 1,002
Ǯɾ(3.3ml) 25,000 22,000 3,000 24,850
޵𿬰(10g) 6,500 6,000 500 6,269
öŸ(34) 13,000 11,000 2,000 11,637
뽺ī(20g) 22,000 18,000 4,000 19,978
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,000 2,000 8,814
ͺ(10) 3,500 2,500 1,000 3,027
ݿ(1ڽ) 3,000 2,500 500 2,948
׶÷糪ƮŸ(6) 8,000 6,500 1,500 7,321
߽Ÿ(120) 70,000 40,000 30,000 51,290
Źĸ(10ĸ) 3,000 3,000 0 3,000
Ÿ̾(120) 60,000 45,000 15,000 49,807
տ(60ĸ) 28,000 25,000 3,000 26,600
Ÿ̷ER(6) 3,500 2,500 1,000 2,969
ٿ(30g) 12,000 9,000 3,000 10,495
(120) 25,000 20,000 5,000 24,267
Ʒ(6) 3,500 3,000 500 3,191
ǽõĸ(270ĸ) 110,000 100,000 10,000 104,250
B(120) 70,000 60,000 10,000 65,556
׳(10) 3,000 2,000 1,000 2,667
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 200,000 30,000 208,333
Ⱦ 12,000 10,000 2,000 11,368
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