Sitemap
Pages
- 2. THE PRINCIPLES OF ICH GCP
- 3. INSTITUTIONAL REVIEW BOARD/INDEPENDENT ETHICS COMMITTEE (IRB/IEC)
- 3.1 Responsibilities
- INTRODUCTION
- 1. GLOSSARY
- 4. INVESTIGATOR
- 5. SPONSOR
- 6. CLINICAL TRIAL PROTOCOL AND PROTOCOL AMENDMENT(S)
- 7. INVESTIGATOR’S BROCHURE
- 8. ESSENTIAL DOCUMENTS FOR THE CONDUCT OF A CLINICAL TRIAL
- 3.2 Composition, Functions and Operations
- 3.3 Procedures
- 3.4 Records
- 4.1 Investigator's Qualifications and Agreements
- 4.2 Adequate Resources
- 4.3 Medical Care of Trial Subjects
- 4.4 Communication with IRB/IEC
- 4.5 Compliance with Protocol
- 4.6 Investigational Product(s)
- 4.8 Informed Consent of Trial Subjects
- 4.9 Records and Reports
- 4.10 Progress Reports
- 4.11 Safety Reporting
- 4.12 Premature Termination or Suspension of a Trial
- 5.1 Quality Assurance and Quality Control
- 5.2 Contract Research Organization (CRO)
- 5.4 Trial Design
- 5.5 Trial Management, Data Handling, and Record Keeping
- 5.6 Investigator Selection
- 5.8 Compensation to Subjects and Investigators
- 5.10 Notification/Submission to Regulatory Authority(ies)
- 5.12 Information on Investigational Product(s)
- 5.13 Manufacturing, Packaging, Labelling, and Coding Investigational Product(s)
- 5.15 Record Access
- 5.16 Safety Information
- 5.17 Adverse Drug Reaction Reporting
- 5.18 Monitoring
- 5.19 Audit
- 5.11 Confirmation of Review by IRB/IEC
- 5.14 Supplying and Handling Investigational Product(s)
- 5.20 Noncompliance
- 5.21 Premature Termination or Suspension of a Trial
- 5.22 Clinical Trial/Study Reports
- 5.23 Multicentre Trials
- 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
- 6.14 Financing and Insurance
- 6.15 Publication Policy
- 6.16 Supplements
- 7.1 Introduction
- 7.2 General Considerations
- 7.4 APPENDIX 1
- 7.3 Contents of the Investigator’s Brochure
- 7.5 APPENDIX 2
- 8.1 Introduction
- 8.2 Before the Clinical Phase of the Trial Commences
- 8.3 During the Clinical Conduct of the Trial
- 8.4 After Completion or Termination of the Trial
- Good Clinical Practice
- GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL
- Legal requirement:
- Purpose of the requirement
- Purpose of this guidance
- Arrangements for notification
- Identifying serious breaches
- Potential actions by the MHRA
- References
- Guidance for Industry Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects
- INTRODUCTION
- OVERVIEW OF INVESTIGATOR RESPONSIBILITIES
- CLARIFICATION OF CERTAIN INVESTIGATOR RESPONSIBILITIES
- The Global Guideline for GCP Audit
- Scope of the Guideline & Definitions
- Sponsor's Auditing Department
- Planning of Audits
- 6. Conduct of an Audit
- 7 Reporting the Results of an Audit
- CAPA, Completion of an Audit & Certificate
- 11 Keeping Audit Records
- Contact us
- Types and roles of clinical trial monitoring committees
- Incentive payments
- Recruitment issues
- Regulatory Inspection
- IMV
- Early Discontinuation of a CT
- Regulatory Inspection
- Project Management
- Download
- Sitemap
- ich-gcp-en.pdf
- ich-gcp-es.pdf
- ich-gcp-de.pdf
- ich-gcp-it.pdf
- Post a Job
- Clinical Research Jobs
- cro-list
- my-account
- Cart