연구자cmcohrp.cmcnu.or.kr/resources/attach/02.연구자.pdf · 2020-02-13 ·...

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_ V e r . 7 . 1 _ 2 0 2 0 0 9 0 1 C H R P P 3 0 1 119 1 . 1. . 2. . 2 . 1. , . 2. IRB IRB ( CR-08) . IRB . 3. IRB . 4. ( ) IRB , CMC (CTSC, Clinical Trial System of CMC) . 5. . . . , , IRB . . , , . . (IRB ) . . IRB , , . 6. . (CHRPP 113 . . (CHRPP 113) _ ( FI-02) (IRB ) . 3 . . (CHRPP 113 . . IRB

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Page 1: 연구자cmcohrp.cmcnu.or.kr/resources/attach/02.연구자.pdf · 2020-02-13 · 신고서_연구자용(별지서식 fi-02)”를 작성하여 irb사무국(행정간사)에 제출하여야

_Ver.7.1_20200901

CHRPP 301

119

1 .

1. .

2.

.

2 .

1. ,

.

2.

IRB IRB ( CR-08)

. IRB .

3. IRB

.

4. ( ) IRB

, CMC

(CTSC, Clinical Trial System of CMC) .

5.

.

.

. , , IRB

.

. , ,

.

.

(IRB )

.

. IRB

, , .

6.

. (CHRPP 113

.

. (CHRPP 113)

_ ( FI-02) (IRB )

. 3 .

. (CHRPP 113

.

. IRB

Page 2: 연구자cmcohrp.cmcnu.or.kr/resources/attach/02.연구자.pdf · 2020-02-13 · 신고서_연구자용(별지서식 fi-02)”를 작성하여 irb사무국(행정간사)에 제출하여야

_Ver.7.1_20200901

CHRPP 301

120

(CHRPP 242 .

7.

.

.

.

. 4-1. "

/ ( CR-03)

.

.

.

.

.

.

.

.

. , , ,

.

8.

. (CHRPP 116)

.

.

.

. (CHRPP 231)

- .

. .

(CHRPP 233)

(CHRPP 116) . IRB 4~8

.

. ( )

,

.

9.

.

.

1)

2)

3)

4)

5)

Page 3: 연구자cmcohrp.cmcnu.or.kr/resources/attach/02.연구자.pdf · 2020-02-13 · 신고서_연구자용(별지서식 fi-02)”를 작성하여 irb사무국(행정간사)에 제출하여야

_Ver.7.1_20200901

CHRPP 301

121

6)

. ,

(Delegation Log)

.

10.

. IRB , IRB

.

, IRB

.

. IRB IRB . 1. IRB

.

. , ,

, .

.

.

. ,

,

,

IRB .

. ,

.

.

.

.

,

.

. , ,

.

. .

. .

. ,

.

.

.

. 3

. IRB " 1. IRB

Page 4: 연구자cmcohrp.cmcnu.or.kr/resources/attach/02.연구자.pdf · 2020-02-13 · 신고서_연구자용(별지서식 fi-02)”를 작성하여 irb사무국(행정간사)에 제출하여야

_Ver.7.1_20200901

CHRPP 301

122

" . (3 )

, 6

.

.

.

11.

. (CHRPP 219)

IRB

.

. IRB

IRB .

, IRB

.

. IRB 1. IRB

.

. 3

IRB .

12.

. IRB IRB

.

. IRB .

(CHRPP 115) .

.

.

IRB

.

.

.

.

IRB .

. IRB

.

. IRB 1.

IRB .

13.

. IRB

.

.

IRB .

Page 5: 연구자cmcohrp.cmcnu.or.kr/resources/attach/02.연구자.pdf · 2020-02-13 · 신고서_연구자용(별지서식 fi-02)”를 작성하여 irb사무국(행정간사)에 제출하여야

_Ver.7.1_20200901

CHRPP 301

123

.

/ / , IRB .

. / / ,

IRB .

. IRB , .

IRB (CHRPP

241) .

. ,

.

.

IRB .

14.

.

. .

.

(IRB ) .

15.

. ,

, .

.

.

.

3 .

.

4 .

1. ( FI-03)

2. ( FI-01)

3. _ ( FI-02)