Good Clinical Practice (ICH E6)

GOOD CLINICAL PRACTICE

Online Course for Clinical Research Staff

Alta Tecnología y Educación, S.L.

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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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