Essential Documents for the Conduct of a Clinical Trial

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Essential Documents for the Conduct of a
Clinical Trial
Clinical Study Documents
Wijittra Natthanonworakarn Roche Thailand Ltd.
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What is the Purpose of Essential Documents?

• Individually and collectively permit evaluation
  of the conduct of a trial and the quality of the
  data produced.
• Demonstrate the compliance of the investigator,
  sponsor and monitor with GCP and other Applicable
  Regulatory Requirement.
• Confirm the validity of the trial conduct and the
  integrity of data
• Become part of a submission to Health Authority
• To assist in the successful management of a trial
  by the investigator, sponsor and monitor

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Trial Master Files

• Trial master files should be established at the
  beginning of the trial.
• Sponsors File
• Investigators File
• Should be kept in a secure location with limited
  access
• GCP does not provide a guideline to organize
  essential documents
• A final close-out of a trial can only be done
  when the monitor has reviewed both investigator
  and sponsor files and confirmed that all
  necessary documents are in the appropriate files.

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Hanging file
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Sponsors File
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Investigators File
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Which Documents are Essential?

• ICH-GCP
• A list of essential documents is provided in
  Chapter 8 of the ICH-GCP guideline.
• Additional documents required by regulations
• Form 1572 (required by US FDA)
• Financial disclosure (as Roche form PD35)
• Defined by Sponsor
• Investigational Staff training (e.g. PD33)
• Lab Normal Values form (PD24)

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GCP part 8
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Additional documents required by regulations
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Additional documents required by regulations

• Form 1572 (required by US FDA)

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Additional documents required by regulations

• Financial disclosure (as Roche form PD35)

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Defined by Sponsor
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Defined by Sponsor

• Investigational Staff training (e.g. PD33)

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Defined by Sponsor

• Lab Normal Values form (PD24)

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The Minimum List of Essential Documents by ICH-GCP

• The various documents are grouped in 3 sections
• Before the clinical phase of the trial commences
• During the clinical conduct of the trial
• After completion or termination of the trial

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Before the clinical phase of the trial commences
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Before the clinical phase of the trial commences
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Before the clinical phase of the trial commences
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During the clinical conduct of the trial
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During the clinical conduct of the trial
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During the clinical conduct of the trial
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After completion or termination of the trial
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After completion or termination of the trial
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Additional Documents for the FDA studies

• This is for the trial conducted under an IND.
• To be completed before the trial starts
• FDA 1572 form (Investigator Statement)
• Financial Disclosure Form

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Roche Documentations

• Pre-study visit report (PD20)
• Site initiation visit report (PD30)
• PD01
• Authorization (PD38)
• Financial (PD35)
• Lab normal value (PD24)
• Monitoring report (PD40)
• Inventory log
• Accountability log
• Drug dispensing log
• Temperature log
• Drug return (PD101)

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Roche Documentations

• Document dispatch form (PD52)
• CRF dispatch form (PD50)
• PD 60 (study close down)
• Training form (PD33)
• Protocol violation form (PD99)
• Database Re-open form (PD80)
• Decoding documentation form (PD65)
• Safety fax cover sheet (PD55)

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The End
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