What is it? Why is it important?

The Clinical Study Report (CSR), also called the Final Study Report (FSR), is a document that summarises the conduct of the study.

It also includes a “safety evaluation” section, where study safety data is described and evaluated.

Safety data is analysed and presented on three levels:

  • Level 1: Extent of exposure: such as dose administered, duration of treatment, number of participants treated in the study (e.g. extent of exposure helps to decide the degree to which safety can be assessed from the study)
  • Level 2: Most common adverse events: including changes in laboratory test parameters
  • Level 3: Serious adverse events: a description of each death, serious adverse event, including the occurrence of other significant adverse events during study conduct

What do I need to do?

As a SP-INV, ensure the following steps are finalised prior to writing the CSR:

  • All open monitoring queries are answered and closed (e.g. eCRF data entry is correct and complete)
  • Monitoring close-out visit is finalised
  • The study database is locked
  • The statistical analyses of the study’s safety data is finalised (e.g. according to SAP)

In the CSR provide:

  • For each patient a summary of all AE occurrences and include:
    • AE start and stop dates
    • Implemented measures and outcome
    • The AE safety assessment (e.g. severity, seriousness, causality, expectedness)
  • Narrative statements of all deaths, all SAEs and other safety events of particular interest
  • A conclusion regarding the study’s safety profile (e.g. discuss the study`s safety profile with potential consequences to its risk-benefit ratio)

More

Submit the CSR within a year after study completion or discontinuation, or as specified in the protocol, to:

  • EC vial BASEC
  • Swissmedic (e.g. only risk category B and C studies)

Where can I get help?

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

External Links

Swissethics – see in particular

  • Templates and checklists / Notifications
    • Study completion / discontinuation

Swissmedic – see in particular information sheet

  • BW101_10_003e_AA Instruction for reporting during the course of a study

References

ICH GCP E3 – Structure and content of CSR

ICH GCP E6(R2) – see in particular guideline

  • 5.22 Clinical trial / Study report

ISO 14155:2020 Medical device (access liable to cost) – see in particular annexes

  • Annex D Clinical investigational report
  • Annex F Adverse event categorization

Swiss Law

FEDLEX – laws are available online under numbers

  • 810.305 ClinO
  • 810.306 ClinO-MD
  • 810.301 HRO

ClinO – see in particular article

  • Art. 38 Notification upon study completion, discontinuation or interruption

ClinO-MD – see in particular article

  • Art. 36 Notification of study termination or interruption

HRO – see in particular articles

  • Art. 22, 36 and 40 Notification of study termination or interruption
Abbreviations
  • AE - Adverse Event
  • BASEC – Business Administration System for Ethics Committees
  • ClinO - Clinical Trials Ordinance
  • ClinO-MD - Ordinance on Clinical Trials with Medical Devices
  • CSR – Clinical Study Report
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – Electronic Data
  • FEDLEX – Publication Platform for Federal Laws
  • FSR – Final Study Report
  • HRO – Human Research with the Exception of Clinical Trials
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO - International Organization for Standardization
  • SAE – Serious Adverse Event
  • SAP – Statistical Analysis Plan
  • SP-INV – Sponsor Investigator
Completion ↦ Safety ↦ Clinical Study Report ↦ Procedures
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 ↦ Safety ↦ Clinical Study Report ↦ Procedures

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