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Daftar Isi: ICH-GCP E6

International Council for Harmonization of GCP


(Addendum - November 2016/2018)

1) Glossary
2) Prinsip ICH-GCP
3) KEPK
3.1 : Responsibilities
3.2 : Composition, Functions and Operations
3.3 : Procedures
3.4 : Records
4) Peneliti
4.1 : Kualifikasi dan Persetujuan Peneliti
4.2 : Sumber Daya yang Memadai
4.3 : Perawatan Medis Subjek Penelitian
4.4 : Komunikasi dengan KEPK
4.5 : Kepatuhan dgn Aplikasi Penelitian yg Disetujui KEPK
4.6 : Produk Penelitian
4.7 : Prosedur Pengacakan dan tidak disamarkan
4.8 : Informed Consent dari Subyek Penelitian
4.9 : Catatan dan Laporan
4.10 : Laporan Kemajuan
4.11 : Pelaporan Keselamatan
4.12 : Penghentian Dini atau Penangguhan Penelitian
4.13 : Laporan Akhir oleh Peneliti

5. Sponsor
5.0 : Quality Management
5.1 : Quality Assurance and Quality Control
5.2 : Contract Research Organization
5.3 : Medical Expertise
5.4 : Trial Design
5.5 : Trial Management, Data Handling, Record Keeping
5.6 : Investigator Selection
5.7 : Allocation of Responsibilities
5.8 : Compensation to Subjects and Investigators
5.9 : Financing
5.10 : Notification/Submission to Regulatory Authority(ies)
5.11 : Confirmation of Review by IRB/IEC
5.12 : Information on Investigational Product(s)
5.13 : Manufacturing, Packaging, Labelling, and Coding
Investigational Product(s)
5.14 : Supplying and Handling Investigational Product(s)
5.15 : Record Access
5.16 : Safety Information
5.17 : Adverse Drug Reaction Reporting
5.18 : Monitoring

 Purpose

 Selection and Qualifications of Monitors

 Extent and Nature of Monitoring

 Monitoring Procedures

 Monitoring Report

 Monitoring Plan
5.19 : Audit

 Purpose

 Selection and Qualification of Auditors

 Auditing Procedures
5.20 : Noncompliance
5.21 : Premature Termination or Suspension of a Trial
5.22 : Clinical Trial/Study Reports
5.23 : Multicentre Trials

6. Clinical Trial Protocol and Protocol Amendment


6.1 : General Information
6.2 : Background Information
6.3 : Trial Objectives and Purpose
6.4 : Trial Design
6.5 : Selection and Withdrawal of Subjects .
6.6 : Treatment of Subjects
6.7 : Assessment of Efficacy
6.8 : Assessment of Safety
6.9 : Statistics
6.10 : Direct Access to Source Data/Documents
6.12 : Ethics
6.13 : Data Handling and Record Keeping
6.14 : Financing and Insurance
6.15 : Publication Policy
6.16. Supplements

7. Investigator’s Brochure
7.1 : Introduction
7.2 : General consideration
7.3 : Table of Content
7.4 : Appendix

8. Essential Documents
8.1 : Introduction
8.2 : Before Trial
8.3 : During Trial
8.4 : After Completion