Your Easy Guide to Clinical Studies

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

 

The report has a “safety evaluation” section, where study safety data is evaluated and described 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 (Investigational Medicinal Product (IMP) = AE, Investigational Medical Device (IMD = ADE): including changes in laboratory test parameters
• Level 3: Serious adverse events (IMP = SAE / SADR, IMD = SDE): a description of each death, serious adverse event, including the occurrence of other significant adverse events during study conduct

 

The CSR is submitted once a year to:

• The Ethics Committee (EC) vial BASEC
• Swissmedic (i.e. for risk-category B and C studies)

As a SP-INV, prior to writing the CSR:

• Finalise and close all open monitoring queries (i.e. ensures data quality and that entries are correct and complete)
• Complete the monitoring close-out
• Lock the study database
• Finalise the statistical analyses of the study’s safety data (e.g. according to SAP)

 

In the CSR provide:

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

 

Submit an CSR once a year to EC/Swissmedic upon study completion/discontinuation, or as specified in the study protocol.

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

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