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 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 (IMP = AE, 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

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 (IMP=AE, IMD=ADE) 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 (IMP=SAE / SADR, IMD=SDE) 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

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