23.06.02 () 03:57

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"̿ CDISC , ƴ ʼ"
̼ 2022-12-01 06:00:20
/home/dailypharm/issueData2017/
ʸƮ
"̿ 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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͸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

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    Ÿ ID Ȥ г ϴ

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    ʴ

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  • 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 06)
౹ 66
ǰ ְ
ڶ(20) 6,500 5,500 1,000 6,214
ѽŻ÷(10) 3,500 2,000 1,500 2,940
޾(100) 25,000 22,000 3,000 23,667
Ʒγΰ(100) 30,000 24,000 6,000 27,773
īɾ(10g) 7,000 5,500 1,500 6,381
Ľõ򿬰(5g) 5,000 3,800 1,200 4,537
Ź(4) 5,000 3,500 1,500 4,314
λ絹÷(100) 37,000 28,900 8,100 31,442
̰źĸ(100) 36,000 30,000 6,000 32,844
(10) 6,000 4,000 2,000 4,848
Ժ(10) 4,000 3,000 1,000 3,373
ڱ׸(20) 5,000 3,500 1,500 4,178
ť(10) 3,000 2,000 1,000 2,761
Ȱť(1) 1,200 800 400 972
Ǯɾ(3.3ml) 25,000 22,000 3,000 23,571
޵𿬰(10g) 7,000 5,000 2,000 6,050
öŸ(34) 13,000 9,800 3,200 11,668
뽺ī(20g) 20,000 18,000 2,000 19,607
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 7,500 2,500 8,861
ͺ(10) 3,500 2,200 1,300 3,011
ݿ(1ڽ) 3,000 2,000 1,000 2,835
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,563
߽Ÿ(120) 70,000 40,000 30,000 53,462
Źĸ(10ĸ) 3,000 2,000 1,000 2,913
Ÿ̾(120) 60,000 40,000 20,000 48,910
տ(60ĸ) 30,000 25,000 5,000 27,925
Ÿ̷ER(6) 3,000 2,500 500 2,530
ٿ(30g) 12,000 8,000 4,000 10,796
(120) 25,000 18,000 7,000 22,063
Ʒ(6) 4,000 3,000 1,000 3,467
ǽõĸ(270ĸ) 110,000 85,000 25,000 0
B(120) 80,000 60,000 20,000 67,059
׳(10) 3,000 2,000 1,000 2,586
6̺(10) 3,000 2,000 1,000 2,920
(60) 250,000 200,000 50,000 215,000
Ⱦ 12,000 9,000 3,000 10,818
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