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ICH Good Clinical Practice Guideline
ISBN : 974-8044-95-5
2
2
I
(Good Clinical Practice: GCP)
GCP
GCP
ICH (International Conference on Harmonization) ICH GCP
ICH GCP
ICH GCP
ICH
GCP ICH
2
1. ICH GCP
2. GCP
(Thai Guideline for Good Clinical Practice)
ICH GCP
ICH GCP
2543
II
3
3
ICH Good
Clinical Practice Guideline (ICH GCP)
2543
4
4
I
II
III
1. 2-9
2. ICH GCP 10
3. , 11-14
4. 15-23
5. 24-34
6. 35-38
7. 39-44
8. 45-53
1 ICH GCP
2 ICH Secretariat ICH GCP
3 ICH Secretariat ICH GCP
5
5
*
(Good Clinical Practice: GCP)
(Declaration of
Helsinki)
ICH GCP
: * ICH
6
6
1. (GLOSSARY)
1.1 (Adverse Drug Reaction: ADR)
�“ �”
[ �“ ICH :
�” (ICH Guideline for Clinical Safety Data Management:
Definitions and Standards for Expedited Reporting)
1.2 (Adverse Event: AE)
( )
( �“ ICH
: �”)
1.3 (Amendment)
�“ (Protocol Amendment)
1.4 (Applicable Regulatory Requirement(s))
(investigational products)
1.5 (Approval) ( : IRB)
IRB
IRB, , GCP,
1.6 (Audit)
,
(Standard Operating Procedures: SOPs) , GCP,
1.7 (Audit Certificate)
7
7
1.8 (Audit Report)
1.9 (Audit Trail)
1.10 (Blinding/Masking)
(Single-
blinding)
2 (Double-blinding)
1.11 (Case Report Form: CRF)
(optical)
1.12 (Clinical Trial/Study)
/
(pharmacodynamics) /
/ (metabolism)
/
(clinical trial) (clinical study)
1.13 (Clinical Trial/Study Report)
, , ( �“ ICH
�” (ICH Guideline for Structure and Content of Clinical Study
Reports)
1.14 (Comparator)
( ) (placebo)
1.15 ( ) (Compliance)
, GCP,
1.16 (Confidentiality)
8
8
1.17 (Contract)
2
1.18 (Coordinating Committee)
1.19 (Coordinating Investigator)
1.20 (Contract Research Organization: CRO)
( )
1.21 (Direct Access)
.
( ,
, )
1.22 (Documentation) (
)
/
1.23 (Essential Documents)
[ 8 �“
�” (Essential Documents for the Conduct of a Clinical Trial)]
1.24 (Good Clinical Practice: GCP)
(integrity)
1.25 (Independent Data-Monitoring Committee:
IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)
, ,
9
9
1.26 (Impartial Witness)
1.27 (Independent Ethics Committee: IEC)
( )
/ , , ,
GCP
1.28 (Informed Consent)
(informed consent form)
1.29 (Inspection)
/
1.30 (Institution)
1.31 (Institutional Review Board: IRB)
, ,
1.32 (Inteim Clinical Trial/Study Report)
10
10
1.33 (Investigational Product)
1.34 (Investigator)
[
�“ �” (Subinvestigator)]
1.35 / (Investigator/Institution) /
1.36 (Investigator�’s Brochure)
(clinical) (nonclinical)
( 7 �“
�”)
1.37 (Legally Acceptable Representative)
1.38 (Monitoring)
, , GCP,
1.39 (Monitoring Repeot)
/
1.40 (Multicentre Trial)
1.41 (Nonclinical Study)
1.42 (Opinion in relation to IEC)
/
11
11
1.43 (Original Medical Record) �“ �”
(Source Documents)
1.44 (Protocol)
.
ICH GCP �“
�”
1.45 (Protocol Amendment)
1.46 (Quality Assurance: QA)
(generated)
GCP
1.47 (Quality Control)
1.48 (Randomization)
1.49 (Regulatory Authorities)
GCP �“
�”
( 1.29) (competent authorities)
1.50 (Serious Adverse Drug Reaction: Serious ADR)
- - -
- /
- /
( �“ ICH :
�”)
1.51 (Source Data)
(
12
12
1.52 (Source Documents)
(
)
1.53 (Sponsor)
/
1.54 (Sponsor-Investigator)
1.55 (Standard Operating Procedures: SOPs)
1.56 (Subinvestigator)
/ (
) �“ �”
1.57 (Subject/Trial Subject)
1.58 (Subject Identification Code)
/
1.59 (Trial Site)
1.60 (Unexpected Adverse Drug Reaction)
(
/
) ( �“ ICH
: �”)
13
13
1.61 (Vulnerable Subjects)
1.62 (Well-being of the trial subjects)
14
14
2. ICH GCP
2.1
GCP
2.2
2.3
2.4
2.5
2.6
/
2.7 ( )
2.8
2.9
2.10
2.11
2.12 (Good
Manufacturing Practice: GMP).
2.13
15
15
3. (Institutional Review
Ethics Committee: IEC)
3.1
3.1.1 IRB/IEC
3.1.2 IRB/IEC
(curriculum vitae) /
IRB/IEC
- /
- /
- /
- / /
3.1.3 IRB/IEC
/ IRB/IEC
3.1.4 IRB/IEC
3.1.5 IRB/IEC 4.8.10
IRB/IEC /
3.1.6 (non-therapeutic trial)
( 4.8.12 4.8.14) IRB/IEC
/
3.1.7 ( 4.8.15) IRB/IEC
/
( )
16
16
3.1.8 IRB/IEC
3.1.9 IRB/IEC
3.2
3.2.1 IRB/IEC
IRB/IEC
. 5
. 1
. 1
IRB/IEC
3.2.2 IRB/IEC
GCP
3.2.3 IRB/IEC
3.2.4 IRB/IEC
/ /
3.2.5
/ IRB/IEC
3.2.6 IRB/IEC
3.3
IRB/IEC
3.3.1 ( )
17
17
3.3.2
3.3.3
3.3.4
3.3.5 /
3.3.6 IRB/IEC
/
3.3.7
/
IRB/IEC
(
) ( 4.5.2)
3.3.8 IRB/IEC
.
( 3.3.7, 4.5.2
4.5.4)
. /
( 4.10.2)
.
.
3.3.9 IRB/IEC /
. /
. /
. /
3.4
IRB/IEC (
/
) 3
18
18
IRB/IEC
19
19
4.
4.1
4.1.1
/ , IRB/IEC, /
4.1.2
4.1.3 GCP
4.1.4 /
4.1.5
4.2
4.2.1
( )
4.2.2
4.2.3
4.2.4
4.3
4.3.1 ( )
( )
20
20
4.3.2
/
/
4.3.3 (primary physician)
4.3.4
4.4 IRB/IEC
4.4.1 / /
IRB/IEC
( )
4.4.2 IRB/IEC /
/
IRB/IEC
4.4.3 /
IRB/IEC
4.5
4.5.1 /
/ IRB/IEC, ,
, /
4.5.2
/
IRB/IEC
( )
21
21
4.5.3
4.5.4
/
IRB/IEC
. IRB/IEC /
.
.
4.6
4.6.1 / -
(accountability)
4.6.2 / / /
-
/
4.5.3 / / /
,
,
(batch/serial numbers) ( )
,
4.5.4 (
5.13.2 5.14.3)
4.5.5
4.5.6 /
4.7
22
22
( )
.
(
)
4.8
4.8.1
GCP
/ IRB/IEC
4.8.2 .
/ IRB/IEC
4.8.3
4.8.4
4.8.5
/ IRB/IEC
4.8.6
( )
4.8.7
23
23
4.8.8
4.8.9
( )
4.8.10
.
. .
. (invasive)
.
.
.
.
.
. /
. ( )
. ( )
.
. IRB/IEC
/
24
24
. /
.
.
.
. /
.
.
4.8.11
.
4.8.12 ( )
( )
4.8.13 4.8.14 (
)
4.8.14
.
.
.
.
. IRB/IEC /
.
25
25
4.8.15
.
/ /
IRB/IRC
.
( 4.8.10)
4.9
4.9.1
4.9.2
4.9.3
( ) (
)
[ 5.18.4 ( )].
/
, , .
4.9.4 / �“
�” ( 8) /
4.9.5 ICH
2
ICH 2
.
/
( 5.5.12)
4.9.6
/
26
26
4.9.7 IRB/IEC
/
4.10
4.10.1 IRB/IEC
IRB/IEC
4.10.2
/ , IRB/IEC
( 3.3.8),
4.11
4.11.1
( )
, ,
/ .
IRB/IEC
4.11.2 /
4.11.3 IRB/IEC
( )
4.12
/
/
4.12.1 / IRB/IEC
27
27
4.12.2 ( 5.21)
/ IRB/IEC
4.12.3 IRB/IEC IRB/IEC /
( 3.1.2 3.3.9) /
4.13 (Final Report)
/
IRB/IEC
28
28
5.
5.1
5.1.1
GCP
5.1.2
( 1.21), /
,
5.1.3
5.1.4 /
5.2 (CRO)
5.2.1 CRO
. CRO
5.2.2 CRO
5.2.3
CRO
5.2.4 CRO
CRO
5.3
5.4
5.4.1 (
)
29
29
5.4.2 : �“
�” [Clinical Trial Protocol and Protocol Amendment(s)] ( 6), �“ ICH
�”, ICH
, ,
5.5
5.5.1 ,
, ,
5.5.2
(critical
efficacy endpolints)
,
5.5.3 /
(remote electronic trial data systems)
.
[ (validation)
.
. [ ,
(data trail), (edit trail) ]
. . (
4.1.5 4.9.3
.
. ( )
)
5.5.1 (transformed)
5.5.2 ( 1.58)
5.5.3
( 8 �“ �”)
5.5.4
/
30
30
5.5.5 (
, , )
2
5.5.6
/
5.5.7
5.5.8
ICH 2
ICH 2
5.5.9 /
/
5.6
5.6.1 /
(
4.1 4.2)
/
5.6.2 /
/
5.6.3 /
. GCP (
4.1.3)
/ IRB/IEC ( 4.5.1)
. /
. (
4.1.4)
.
( 4.9.4 5.5.12)
/
5.7
31
31
5.8
5.8.1
( ) /
(malpractice) / (negligence)
5.8.2
5.8.3
5.9
/
5.10 /
(
)
/ (
) /
5.11 IRB/IEC
5.11.1 /
. IRB/IEC /
. IRB/IEC IRB/IEC GCP
. / IRB/IEC
/
IRB/IEC /
5.11.2 IRB/IEC /
(modification) ,
, /
/
/ IRB/IEC
32
32
5.11.3 /
IRB/IEC /
5.12
5.12.1
/
(route)
5.12.2 ( 7 �“ �”)
5.13
5.13.1 (characterized)
( )
/ ( ).
5.13.2
( )
( ).
( )
5.13.3
5.13.4
5.13.5
(
)
5.14
5.14.1 /
5.14.2 /
( / IRB/IEC
)
33
33
5.14.3
/
.
(
)
5.14.4 .
.
( 8 �“ �”)
. (
)
.
5.14.5 .
.
(specifications) ( )
.
5.15
5.15.1
/ /
IRB/IEC
5.15.2
IRB/IEC
5.16
5.16.1
5.16.2 /
/ IRB/IEC
34
34
5.17 / IRB(s)/IEC(s)
5.17.2
�“ ICH :
�”
5.17.3 (safety updates)
5.18
5.18.1 (purpose)
.
.
. /
GCP
5.18.2
.
.
/
. ,
, , ,
GCP,
5.18.3
,
(extensive written guidance)
GCP .
5.18.4
.
. ( 4.1,
4.2, 5.6)
35
35
. (1)
(2)
(3)
(4)
(5)
.
( )
.
.
.
.
/
.
. , , ,
.
(applications and submissions)
.
.
(1).
(2). /
(3). , ,
(4).
36
36
(5). (drop out)
.
(
)
.
.
GCP, , IRB/IEC, ,
. ( 8 �“
�”)
. ,
, GCP,
8.18.5
5.18.6
.
.
. (summary)
/ ,
, ,
, /
.
5.19
5.19.1
, , GCP,
5.19.2
37
37
. /
.
.
5.19.3
.
.
,
, , ,
.
.
.
GCP
.
5.20
5.20.1 , , GCP, /
/
5.20.2 /
/ /
/
5.21
/
. IRB/IEC /
38
38
5.22
�“ ICH
�” ( : �“ ICH �”
)
5.23
5.23.1
/
IRB/IEC
5.23.2 .
5.23.3
5.23.4 .
,
5.23.5
39
39
6.
6.1
6.1.1
6.1.2 ( )
6.1.3
6.1.4 (
)
6.1.5
6.1.6 (
) ( )
( )
6.1.7 /
/
6.2
6.2.1 6.2.2
6.2.3 ( )
6.2.4 (dosage
regimen)
6.2.5 , GCP,
6.2.6 6.2.7
6.3
40
40
6.4 (scientific integrity)
6.4.1 ( )
6.4.2 / [
, (placebo-controlled),
(parallel design)
6.4.3
.
. 6.4.4
(dosage form)
6.4.5
( )
6.4.6 (stopping rules) (discontinuation
criteria)
6.4.7 -
( )
6.4.8 (trial treatment randomization codes)
6.4.9 (
)
6.5
6.5.1 6.5.2 6.5.3 (
)
.
. .
.
41
41
6.6 6.6.1 /
6.6.2 / ( )
/
6.6.3
6.7 6.7.1 (efficacy parameters)
6.7.2
6.8 6.8.1 (safety parameters)
6.8.2
6.8.3
6.8.4
6.9 6.9.1
[(planned interim analysis(ses)]
6.9.2
(
) (power)
6.9.3
6.9.4 6.9.5 , ,
6.9.6 (
/
)
6.9.7 (
)
6.10
/
IRB/IEC
42
42
6.11
6.12
6.13
6.14
6.15
6.16
(
�“ ICH �”)
43
43
7. (Investigator�’s Brochure; IB)
7.1
/
.
. (objective)
.
. (
)
. GCP
IRB/IEC /
IRB/IEC.
.
7.2
7.2.1 , (
) .
1
44
44
7.2.2 /
IRB/IEC
7.3
7.3.1 2
7.3.2
( 2 )
7.3.3
(
) , ,
( ),
,
.
7.3.4
( /
)
.
7.3.5
.
( )
(dose interval)
45
45
(duration of dosing)
- - - -
- -
,
, .
( ).
/
1
.
(
) (
)
.
.
(local and systemic
bioavailability)
.
( )
( )
46
46
7.3.6
, , ,
, , , ,
.
( )
- (
)
- (
)
- ( )
- (
)
. (
) , , ,
(
/ ). (implications) .
.
( ) .
/
.
.
. (
).
/
/
7.3.7
47
47
.
.
7.4. 1
( )
:
:
: ( )
( )
- :
- :
- :
- :
7.5 2
( )
- ( )
- ( )
1. 2. 3.
4.
5.
5.1 5.2
5.3 6.
6.1 6.2
48
48
6.3 7.
: 1.
2.
( )
49
49
8.
8.1
GCP
. /
.
(validity)
(integrity)
3
1. 2.
3.
/ 2 .
/
/
8.2
50
50
/
8.2.1
8.2.2
( )
/
8.2.3 -
(
)
-
(
)
-
( )
8.2.4
/
8.2.5
( )
8.2.6
- /
- /
( )
-
51
51
- /
( )
8.2.7 /
/
-
- ( )
-
-
-
( )
- -
( )
-
/
8.2.8 IRB/IEC
IRB/IEC GCP ( )
8.2.9 / /
/ / ( ) ( )
( )
8.2.10
/ /
8.2.11 / /
/
/ /
8.2.12 /
/ - ( )
/
-
-
(accreditation)
-
52
52
/ -
-
(validation) ( )
8.2.13
-
8.2.14
(
)
8.2.15
-
- -
8.2.16
8.2.17
(
)
8.2.18
(master randomi- (
zation list) )
8.2.19
(
8.2.20)
8.2.20
(
8.2.19)
53
53
8.3
/
8.3.1
8.3.2
- /
-
-
-
( )
8.3.3 /
/
IRB/IEC IRB/IEC
/
/
-
-
(1) (2)
(3)
( )
-
/
-
( )
54
54
8.3.4 /
/ ( )
( )
-
8.3.5 ( 8.2.10)
/
8.3.6 / /
/
/ ( 8.2.11)
/
8.3.7
/ ( )
/ ( 8.2.12)
/
-
-
-
/ -
-
( )
8.3.8 - ( 8.2.15)
8.3.9 - ( 8.2.16)
(new batches)
8.3.10
8.3.11
,
- , ,
-
-
55
55
8.3.12
GCP
( 8.2.3)
8.3.13
,
, -
8.3.14
- ( ) ( )
8.3.15 /
- ( ) ( )
8.3.16 -
-
4.11
8.3.17 /
( )
/ IRB/IEC
( ) 5.17 4.11.1
IRB/IEC 5.16.2
8.3.18
5.16.2
8.3.19
( )
IRB/IEC IRB/IEC 4.10
5.17.3
8.3.20 -
(subject ( )
screening log)
8.3.21 /
(subject -
56
56
identification code list)
/
8.3.22 -
(subject
enrolment log)
8.3.23
-
8.3.24
(signature sheet) /
8.3.25
/ ( )
(assay)
8.3 8.2 8.3
/
8.4.1 -
-
,
, ,
8.4.2 - -
(
)
8.4.3 -
(completed subject)
identification code list)
8.4.4
( )
8.4.5
(final trial close-out
report)
57
57
8.4.6
(treatment
allocation)
(decoding
documentation)
8.4.7
IRB/IEC (
)
(
)
8.4.8
( )