Documente Academic
Documente Profesional
Documente Cultură
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
Monitoring Procedures
Monitoring Report
Monitoring Plan
5.19 : Audit
Purpose
Auditing Procedures
5.20 : Noncompliance
5.21 : Premature Termination or Suspension of a Trial
5.22 : Clinical Trial/Study Reports
5.23 : Multicentre Trials
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