Good Clinical Practice - Advanced Principles

Program

Introduction to ICH-GCP

• Historical background

• Definition and scope 

• 13 Core principles

• Guidelines content

• Legislation

• Clinical development programme

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Responsibilities of Sponsor

• Definition

• Main responsibilities

• Trial design, management and reporting

o Clinical trial protocol: 

- Definition and remit

- Content

- Transparency

o Trial management, data handling, record keeping

o Trial Master File (Essential documents)

o Record access

o Safety review and reporting

o Premature termination or suspension of trial

o Notification/submission to regulatory authorities

o Reporting of results

• Resources

o Investigator selection

o Medical expertise

o Delegation to a CRO

o Allocation of responsibilities

o Appoint monitors

• Quality assurance and quality control

o IRB/IEC review confirmation

o Audit

o Non-compliance actions

• Financing

• Investigational product

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Responsibilities of Investigator

• Qualifications

• Key roles & responsibilities of a clinical research investigator 

• Definition and details about investigator`s brochure 

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Responsibilities of Ethics Committee

• Definition

• Difference between IRB and IEC

• Main responsibilities

• Membership

• Procedures

• Functions and operations 

• In relation with investigator and sponsor

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Patient Recruitment

• Informed consent:

o Definition of Informed consent 

o Critical points and content

o Process

o Who

Conduct and Monitoring

• Trial monitoring purpose and qualifications

• Responsibilities

• Monitoring report

• Audit

• Source data and source documents

• Case Report Form

o Definition

o Content

• Safety data

o Adverse Event

o Adverse Drug Reaction

o Unexpected Adverse Drug Reaction

o Serious Adverse Event

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Essential Documents during the Trial Conduct

• Overview documents necessary during the trial conduct

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Closure

• Criteria

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Result Analysis and Interpretation

• Clinical Study Report

o Definition and purpose

o Content

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Essential Documents after Completion of the Trial

• Overview documents after completion of the trial

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Communication of Trial Results

• Clinical Study Report communication

• Publication

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Data Filed and Registration Obtained

• According ICH-GCP

• World Health Organization

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