1.45 Protocol Amendment for GCP

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European Medicines Agency

7 Westferry Circus, Canary Wharf, London, E14 4HB, UKTel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40E-mail: mail@emea.eu.int http://www.emea.eu.int

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EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged

July 2002CPMP/ICH/135/95

ICH Topic E 6 (R1)Guideline for Good Clinical PracticeStep 5NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE

(CPMP/ICH/135/95)

TRANSMISSION TO CPMP July 1996FINAL APPROVAL BY CPMP July 1996DATE FOR COMING INTO OPERATION January 1997POST STEP ERRATA (linguistic minor corrections) July 2002

© EMEA 2006 2

GUIDELINE FOR GOOD CLINICAL PRACTICEICH Harmonised Tripartite GuidelineINTRODUCTION....................................................................................................................5

1.

GLOSSARY.......................................................................................................................5

1.1 A

DVERSE

D

RUG

R

EACTION

(ADR)...............................................................................51.2 A

DVERSE

E

VENT

(AE)..................................................................................................51.3 A

MENDMENT

(

TO THE PROTOCOL

)................................................................................61.4 A

PPLICABLE

R

EGULATORY

R

EQUIREMENT

(

S

)...............................................................61.5 A

PPROVAL

(

IN RELATION TO

I

NSTITUTIONAL

R

EVIEW

B

OARDS

)...................................61.6 A

UDIT

...........................................................................................................................61.7 A

UDIT

C

ERTIFICATE

......................................................................................................61.8 A

UDIT

R

EPORT

..............................................................................................................61.9 A

UDIT

T

RAIL

................................................................................................................61.10 B

LINDING

/M

ASKING

.....................................................................................................61.11 C

ASE

R

EPORT

F

ORM

(CRF)..........................................................................................61.12 C

LINICAL

T

RIAL

/S

TUDY

...............................................................................................71.13 C

LINICAL

T

RIAL

/S

TUDY

R

EPORT

..................................................................................71.14 C

OMPARATOR

(P

RODUCT

)............................................................................................71.15 C

OMPLIANCE

(

IN RELATION TO TRIALS

)........................................................................71.16 C

ONFIDENTIALITY

........................................................................................................71.17 C

ONTRACT

....................................................................................................................71.18 C

OORDINATING

C

OMMITTEE

.........................................................................................71.19 C

OORDINATING

I

NVESTIGATOR

....................................................................................71.20 C

ONTRACT

R

ESEARCH

O

RGANIZATION

(CRO).............................................................71.21 D

IRECT

A

CCESS

............................................................................................................81.22 D

OCUMENTATION

.........................................................................................................81.23 E

SSENTIAL

D

OCUMENTS

...............................................................................................81.24 G

OOD

C

LINICAL

P

RACTICE

(GCP)................................................................................81.25 I

NDEPENDENT

D

ATA

-M

ONITORING

C

OMMITTEE

(IDMC) (D

ATA AND

S

AFETY

M

ONITORING

B

OARD

, M

ONITORING

C

OMMITTEE

, D

ATA

M

ONITORING

C

OMMITTEE

).............81.26 I

MPARTIAL

W

ITNESS

.....................................................................................................81.27 I

NDEPENDENT

E

THICS

C

OMMITTEE

(IEC).....................................................................81.28 I

NFORMED

C

ONSENT

.....................................................................................................91.29 I

NSPECTION

...................................................................................................................91.30 I

NSTITUTION

(

MEDICAL

)................................................................................................91.31 I

NSTITUTIONAL

R

EVIEW

B

OARD

(IRB).........................................................................91.32 I

NTERIM

C

LINICAL

T

RIAL

/S

TUDY

R

EPORT

....................................................................91.33 I

NVESTIGATIONAL

P

RODUCT

.........................................................................................91.34 I

NVESTIGATOR

..............................................................................................................91.35 I

NVESTIGATOR

/ I

NSTITUTION

.......................................................................................91.36 I

NVESTIGATOR

'

S

B

ROCHURE

.......................................................................................101.37 L

EGALLY

A

CCEPTABLE

R

EPRESENTATIVE

..................................................................101.38 M

ONITORING

..............................................................................................................101.39 M

ONITORING

R

EPORT

.................................................................................................101.40 M

ULTICENTRE

T

RIAL

..................................................................................................101.41 N

ONCLINICAL

S

TUDY

..................................................................................................101.42 O

PINION

(

IN RELATION TO

I

NDEPENDENT

E

THICS

C

OMMITTEE

)..................................101.43 O

RIGINAL

M

EDICAL

R

ECORD

.....................................................................................10

© EMEA 2006 3

1.44 P

ROTOCOL

..................................................................................................................101.45 P

ROTOCOL

A

MENDMENT

............................................................................................101.46 Q

UALITY

A

SSURANCE

(QA).......................................................................................111.47 Q

UALITY

C

ONTROL

(QC)............................................................................................111.48 R

ANDOMIZATION

........................................................................................................111.49 R

EGULATORY

A

UTHORITIES

.......................................................................................111.50 S

ERIOUS

A

DVERSE

E

VENT

(SAE)

OR

S

ERIOUS

A

DVERSE

D

RUG

R

EACTION

(S

ERIOUS

ADR) 111.51 S

OURCE

D

ATA

............................................................................................................111.52 S

OURCE

D

OCUMENTS

.................................................................................................111.53 S

PONSOR

.....................................................................................................................121.54 S

PONSOR

-I

NVESTIGATOR

............................................................................................121.55 S

TANDARD

O

PERATING

P

ROCEDURES

(SOP

S

)............................................................121.56 S

UBINVESTIGATOR

......................................................................................................121.57 S

UBJECT

/T

RIAL

S

UBJECT

............................................................................................121.58 S

UBJECT

I

DENTIFICATION

C

ODE

.................................................................................121.59 T

RIAL

S

ITE

..................................................................................................................121.60 U

NEXPECTED

A

DVERSE

D

RUG

R

EACTION

..................................................................121.61 V

ULNERABLE

S

UBJECTS

.............................................................................................131.62 W

ELL

-

BEING

(

OF THE TRIAL SUBJECTS

)......................................................................13

2.

THE PRINCIPLES OF ICH GCP.................................................................................13

3.1 R

ESPONSIBILITIES

.......................................................................................................143.2 C

OMPOSITION

, F

UNCTIONS AND

O

PERATIONS

............................................................153.3 P

ROCEDURES

...............................................................................................................163.4 R

ECORDS

....................................................................................................................17

4.

INVESTIGATOR............................................................................................................17

4.1 I

NVESTIGATOR

'

S

Q

UALIFICATIONS AND

A

GREEMENTS

...............................................174.2 A

DEQUATE

R

ESOURCES

..............................................................................................174.3 M

EDICAL

C

ARE OF

T

RIAL

S

UBJECTS

...........................................................................184.4 C

OMMUNICATION WITH

IRB/IEC...............................................................................184.5 C

OMPLIANCE WITH

P

ROTOCOL

...................................................................................184.6 I

NVESTIGATIONAL

P

RODUCT

(

S

)..................................................................................194.7 R

ANDOMIZATION

P

ROCEDURES AND

U

NBLINDING

.....................................................194.8 I

NFORMED

C

ONSENT OF

T

RIAL

S

UBJECTS

...................................................................204.9 R

ECORDS AND

R

EPORTS

.............................................................................................234.10 P

ROGRESS

R

EPORTS

....................................................................................................244.11 S

AFETY

R

EPORTING

....................................................................................................244.12 P

REMATURE

T

ERMINATION OR

S

USPENSION OF A

T

RIAL

............................................244.13 F

INAL

R

EPORT

(

S

)

BY

I

NVESTIGATOR

..........................................................................25

5.

SPONSOR........................................................................................................................25

5.1 Q

UALITY

A

SSURANCE AND

Q

UALITY

C

ONTROL

.........................................................255.2 C

ONTRACT

R

ESEARCH

O

RGANIZATION

(CRO)...........................................................255.3 M

EDICAL

E

XPERTISE

..................................................................................................255.4 T

RIAL

D

ESIGN

.............................................................................................................265.5 T

RIAL

M

ANAGEMENT

, D

ATA

H

ANDLING

,

AND

R

ECORD

K

EEPING

..............................265.6 I

NVESTIGATOR

S

ELECTION

..........................................................................................275.7 A

LLOCATION OF

R

ESPONSIBILITIES

.............................................................................285.8 C

OMPENSATION TO

S

UBJECTS AND

I

NVESTIGATORS

...................................................285.9 F

INANCING

..................................................................................................................28

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