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Good Clinical Practice,as describe in the ICH E6 is a internationally accepted standard to perform clinical trials with humans worldwide. GCP must be observed in addition to aplicable national or regional standards (as the Directive 2001/20/EC).
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GOOD CLINICAL PRACTICE
Online Course for Clinical Research Staff
Alta Tecnología y Educación, S.L.
Professional Training SolutionsE-learning, in-company, multimedia and streaming
Content of this lesson
1.What is a Clinical Trial Protocol
2.ICH Requirements
3.Content required
The Clinical Trial Protocol
What is a Trial Protocol?
It is the guidance document to perform the clinical project in order to answer the scientific question that the trial tries to address.
ICH Requirements
• It needs to have a standard content•Details are provided by section 6 of ICH E6.
Content of the Protocol
•General overview and background•Objectives, purpose and design• Selection and Withdrawal of Subjects• Treatment of Subjects• Assessment of Efficacy and Safety• Statistics
Content of the Protocol
•Direct Access to Source Data/Documents•Quality Control and Quality Assurance• Ethics•Data Handling and Record Keeping• Financing and Insurance• Publication Policy• Supplements
The Clinical Trial Protocol
•Some of the above items may be contained in other essential documents (e.g the Investigator Brochure)
• It should be dated (mandatory)
•Version is optional
• It should be signed both by the sponsor and the investigator
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