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  • Essential Documents For The Conduct of A Clinical Trial: Chapter-6

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    This chapter outlines the essential documents needed for conducting a clinical trial, including the protocol, investigator's brochure, informed consent form, clinical trial agreement, laboratory certifications and standard operating procedures. It discusses the documents required before, during and after a trial, such as the protocol, amendments, safety reports and final study report. Maintaining accurate essential documents is important for regulatory compliance and protecting subject safety.

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    This chapter outlines the essential documents needed for conducting a clinical trial, including the protocol, investigator's brochure, informed consent form, clinical trial agreement, laboratory certifications and standard operating procedures. It discusses the documents required before, during and after a trial, such as the protocol, amendments, safety reports and final study report. Maintaining accurate essential documents is important for regulatory compliance and protecting subject safety.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    26 views8 pages

    Essential Documents For The Conduct of A Clinical Trial: Chapter-6

    Uploaded by

    priyadarsh
    This chapter outlines the essential documents needed for conducting a clinical trial, including the protocol, investigator's brochure, informed consent form, clinical trial agreement, laboratory certifications and standard operating procedures. It discusses the documents required before, during and after a trial, such as the protocol, amendments, safety reports and final study report. Maintaining accurate essential documents is important for regulatory compliance and protecting subject safety.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
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    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    Chapter- 6
    Essential Documents For The Conduct Of A Clinical Trial

    Introduction

    www.clinomic.in 42
    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    Before The Clinical Phase Of The Trial Commences

    www.clinomic.in 43
    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    www.clinomic.in 44
    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    www.clinomic.in 45
    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    During the clinical conduct of the trial

    www.clinomic.in 46
    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    www.clinomic.in 47
    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    www.clinomic.in 48
    Chapter- 6 Essential Documents for the Conduct of a Clinical Trial

    After Completion or Termination of the Trial

    www.clinomic.in 49

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