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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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  • īī
  • ̽
  • 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 (2024 04)
౹ 31
ǰ ְ
ѽŻ÷(10) 3,500 2,500 1,000 3,009
޾(100) 24,000 23,000 1,000 23,200
Ʒγΰ(100) 30,000 28,000 2,000 28,500
īɾ(10g) 7,000 6,000 1,000 6,559
Ľõ򿬰(5g) 5,000 4,500 500 5,138
Ź(4) 5,000 4,000 1,000 4,438
ڶ(20) 6,000 6,000 0 6,000
(10) 6,000 4,500 1,500 5,071
Ժ(10) 4,000 3,500 500 3,712
ڱ׸(20) 5,000 4,500 500 4,717
ť(10) 3,000 2,500 500 2,990
Ȱť(1) 1,200 900 300 1,182
Ǯɾ(3.3ml) 26,000 23,000 3,000 24,250
޵𿬰(10g) 7,000 5,900 1,100 6,289
öŸ(34) 13,000 11,000 2,000 11,866
뽺ī(20g) 22,000 18,000 4,000 20,184
ġ(1) 1,000 1,000 0 1,000
ӽ÷(21) 10,000 8,500 1,500 9,205
ͺ(10) 3,500 3,000 500 3,196
ݿ(1ڽ) 3,000 3,000 0 3,000
׶÷糪ƮŸ(6) 8,000 7,000 1,000 7,524
߽Ÿ(120) 70,000 50,000 20,000 60,385
Źĸ(10ĸ) 3,000 2,000 1,000 2,989
Ÿ̾(120) 60,000 50,000 10,000 51,538
տ(60ĸ) 29,000 25,000 4,000 27,600
Ÿ̷ER(6) 3,000 2,500 500 2,750
ٿ(30g) 12,000 9,000 3,000 11,444
(120) 25,000 22,000 3,000 24,991
Ʒ(6) 4,000 3,000 1,000 3,262
ǽõĸ(270ĸ) 110,000 110,000 0 110,000
B(120) 70,000 70,000 0 70,000
׳(10) 3,000 2,500 500 2,778
6̺(10) 3,000 3,000 0 3,000
(60) 230,000 220,000 10,000 223,333
Ⱦ 12,000 10,000 2,000 10,143
̰źĸ(60ĸ) 35,000 30,000 5,000 33,231
Ųť(20) 5,500 4,500 1,000 4,903
λ絹÷(100) 35,000 32,000 3,000 33,297
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