ich-e6-r1-guideline-good-clinical-practice_en.pdf - European Medicines Agency July 2002 CPMP\/ICH\/135\/95 ICH Topic E 6(R1 Guideline for Good Clinical

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European Medicines Agency 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 85 75 Fax (44-20) 75 23 70 40 E-mail: [email protected] EMEA 2006 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged July 2002 CPMP/ICH/135/95 ICH Topic E 6 (R1) Guideline for Good Clinical Practice Step 5 NOTE FOR GUIDANCE ON GOOD CLINICAL PRACTICE (CPMP/ICH/135/95) TRANSMISSION TO CPMP July 1996 FINAL APPROVAL BY CPMP July 1996 DATE FOR COMING INTO OPERATION January 1997 POST STEP ERRATA (linguistic minor corrections) July 2002
© EMEA 2006 2 TABLE OF CONTENT INTRODUCTION ......................................................................................................................... 5 1. GLOSSARY ............................................................................................................................ 5 1.1 A DVERSE D RUG R EACTION (ADR) ................................................................................... 5 1.2 A DVERSE E VENT (AE) ....................................................................................................... 5 1.3 A MENDMENT ( TO THE PROTOCOL ) ..................................................................................... 5 1.4 A PPLICABLE R EGULATORY R EQUIREMENT ( S ) ................................................................... 5 1.5 A PPROVAL ( IN RELATION TO I NSTITUTIONAL R EVIEW B OARDS ) ....................................... 5 1.6 A UDIT ................................................................................................................................ 5 1.7 A UDIT C ERTIFICATE .......................................................................................................... 6 1.8 A UDIT R EPORT .................................................................................................................. 6 1.9 A UDIT T RAIL ..................................................................................................................... 6 1.10 B LINDING /M ASKING .......................................................................................................... 6 1.11 C ASE R EPORT F ORM (CRF) ............................................................................................... 6 1.12 C LINICAL T RIAL /S TUDY .................................................................................................... 6 1.13 C LINICAL T RIAL /S TUDY R EPORT ....................................................................................... 6 1.14 C OMPARATOR (P RODUCT ) ................................................................................................. 6 1.15 C OMPLIANCE ( IN RELATION TO TRIALS ) ............................................................................. 6 1.16 C ONFIDENTIALITY ............................................................................................................. 6 1.17 C ONTRACT ......................................................................................................................... 6 1.18 C OORDINATING C OMMITTEE ............................................................................................. 6 1.19 C OORDINATING I NVESTIGATOR ......................................................................................... 7 1.20 C ONTRACT R ESEARCH O RGANIZATION (CRO) .................................................................. 7 1.21 D IRECT A CCESS ................................................................................................................. 7 1.22 D OCUMENTATION .............................................................................................................. 7 1.23 E SSENTIAL D OCUMENTS .................................................................................................... 7 1.24 G OOD C LINICAL P RACTICE (GCP) ..................................................................................... 7 1.25 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 ) .................. 7 1.26 I MPARTIAL W ITNESS ......................................................................................................... 7 1.27 I NDEPENDENT E THICS C OMMITTEE (IEC) ......................................................................... 7 1.28 I NFORMED C ONSENT ......................................................................................................... 8 1.29 I NSPECTION ....................................................................................................................... 8 1.30 I NSTITUTION ( MEDICAL ) .................................................................................................... 8 1.31 I NSTITUTIONAL R EVIEW B OARD (IRB) .............................................................................. 8 1.32 I NTERIM C LINICAL T RIAL /S TUDY R EPORT ........................................................................ 8 1.33 I NVESTIGATIONAL P RODUCT ............................................................................................. 8 1.34 I NVESTIGATOR ................................................................................................................... 8 1.35 I NVESTIGATOR / I NSTITUTION ............................................................................................ 8 1.36 I NVESTIGATOR ' S B ROCHURE .............................................................................................. 8 1.37 L EGALLY A CCEPTABLE R EPRESENTATIVE ......................................................................... 8 1.38 M ONITORING ..................................................................................................................... 9 1.39 M ONITORING R EPORT ........................................................................................................ 9 1.40 M ULTICENTRE T RIAL ........................................................................................................ 9 1.41 N ONCLINICAL S TUDY ........................................................................................................ 9 1.42 O PINION ( IN RELATION TO I NDEPENDENT E THICS C OMMITTEE ) ......................................... 9 1.43 O RIGINAL M EDICAL R ECORD ............................................................................................ 9 1.44 P ROTOCOL ......................................................................................................................... 9 1.45 P ROTOCOL A MENDMENT ................................................................................................... 9
© EMEA 2006 3 1.46 Q UALITY A SSURANCE (QA) .............................................................................................. 9 1.47 Q UALITY C ONTROL (QC) .................................................................................................. 9 1.48 R ANDOMIZATION .............................................................................................................. 9 1.49 R EGULATORY A UTHORITIES .............................................................................................. 9 1.50 S ERIOUS A DVERSE E VENT (SAE) OR S ERIOUS A DVERSE D RUG R EACTION (S ERIOUS ADR) 9 1.51 S OURCE D ATA ................................................................................................................. 10 1.52 S OURCE D OCUMENTS ...................................................................................................... 10 1.53 S PONSOR ......................................................................................................................... 10 1.54 S PONSOR -I NVESTIGATOR ................................................................................................ 10 1.55 S TANDARD O PERATING P ROCEDURES (SOP S ) ................................................................ 10 1.56 S UBINVESTIGATOR .......................................................................................................... 10 1.57 S UBJECT /T RIAL S UBJECT ................................................................................................. 10 1.58 S UBJECT I DENTIFICATION C ODE ...................................................................................... 10 1.59 T RIAL S ITE ...................................................................................................................... 10 1.60 U NEXPECTED A DVERSE D RUG R EACTION ....................................................................... 10 1.61 V ULNERABLE S UBJECTS .................................................................................................. 11 1.62 W ELL - BEING ( OF THE TRIAL SUBJECTS ) ........................................................................... 11 2. THE PRINCIPLES OF ICH GCP ..................................................................................... 11 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC) ..................................................................................................................................... 12 3.1 R ESPONSIBILITIES ............................................................................................................ 12 3.2 C OMPOSITION , F UNCTIONS AND O PERATIONS ................................................................. 13 3.3 P ROCEDURES ................................................................................................................... 13 3.4 R ECORDS ......................................................................................................................... 14 4. INVESTIGATOR ................................................................................................................ 14 4.1 I NVESTIGATOR ' S Q UALIFICATIONS AND A GREEMENTS .................................................... 14 4.2 A DEQUATE R ESOURCES .................................................................................................. 15 4.3 M EDICAL C ARE OF T RIAL S UBJECTS ............................................................................... 15 4.4 C OMMUNICATION WITH IRB/IEC .................................................................................... 15 4.5 C OMPLIANCE WITH P ROTOCOL ........................................................................................ 16 4.6 I NVESTIGATIONAL P RODUCT ( S ) ....................................................................................... 16 4.7 R ANDOMIZATION P

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