What is it? Why is it important?

A final study report is an account describing in detail the methods, events and results of a study. The reporting of the risk management of the study is an important integral part of this document.

Part of the report describes the QMS implemented during the study:

  • Identified and categorised study risks including applicable control measures
  • Important deviations and remedial actions taken

The SP-INV submits the final study report to the EC and RA as applicable.

What do I need to do?

Based on the RAT:

  • Describe the risk-based QMS implemented in your study
  • Summarise important deviations and remedial actions taken
  • If you have been audited include the audit certificates
  • Complete other report sections and submit the report to the EC and RA as applicable

The final study report must be submitted to the EC within 1 year after completion (last visit of the last participant) or discontinuation of the study.

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guidelines

  • 1.6 Audit
  • 5.0 Quality management

ISO 9001 – see in particular section

  • QMS Requirements (access liable to costs)

    Swiss Law

ClinO – see in particular article

  • Art 38 Final report

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • QMS – Quality Management System
  • RA – Regulatory Authorities
  • RAT - Risk Assessment Tool
  • SP-INV – Sponsor-Investigator
Completion ↦ Quality and Risk ↦ Final Study Report ↦ Risk Reporting
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Completion ↦ Quality and Risk ↦ Final Study Report ↦ Risk Reporting

Please note: the Easy-GCS tool is currently under construction.