Your Easy Guide to Clinical Studies

A Clinical (final) Study Report (CSR), is a standardized report, that describes the methods and results of an implemented study.

A CSR is submitted to the respective Ethics Committee (EC) and regulatory authorities (e.g. Swissmedic, international).

 

The submission of CSR also applies when a study has been terminated or prematurely interrupted.

 

During study planning, the SP-INV used a risk-based approach, incorporating Quality-by-Design (QbyD) into the design of the study. An important integral part of QbyD is the identification of the study`s Critical-to-Quality (CtoQ) factors. The identification of risks threatening QtoQ is important to protect the:

• Right and safety of study participants
• Quality of study data
• Reliability and credibility of study results

 

In the CSR, the SP-INV must include and describe the quality management of the study, its risk-based and QbyD approach, including processes used to identify CtoQ factors, including risks threatening their integrity.

As a SP-INV:

• Ensure the design of the CSR is part of the QbyD approach of your study. Follow and comply with CSR specifications provided by ICH E3
• Describe the risk-based Quality Management System implemented in your study, emphasizing its role in ensuring participant safety and data integrity
• Summarise important deviations, including root-cause analysis and Corrective and Preventive Actions taken (e.g. describe deviations from the statistical analysis plan)
• If you have been audited include the audit certificate
• In a multicentre study, provide participating Ste-INV with a summary of study results, to be filed in the Investigator Site File
• Provide, and ask participating Site-INV(s), to submit a summary of study results to study participants. Ensure language used is non-technical, easily understood by a layperson
• Submit the report to the EC and Swissmedic within regulatory required timelines

References

ICH GCP E6(R3) – see in particular guidelines

• Glossary: Clinical Trial / Study Report (CSR); Interim Clinical Trial / Study Report
• 2.13 Reports (Site-INV)
• 3.10 Quality Management
• 3.17.1 Premature Termination or Suspension of a trial
• 3.17.2 Clinical Trial / Study Reports (SP-INV)

E8(R1) – see in particular guidelines

• 2.2 Scientific approach in clinical study design
• 3. Designing quality into clinical studies
• 3.1 Quality by design of clinical studies
• 5. Design elements and data sources for clinical studies
• 5.6 Statistical analysis
• 6.3 Study reporting

ICH E3 – in particular see guidelines for submission to Swissmedic

• All Sections: Structure and Content of Clinical Study reports

ISO 9001 (access liable to costs – see in particular section

• QMS Requirements

Swiss Law

ClinO – see in particular articles

• Art. 36, 38 Specifications regarding final study report

ClinO-MD – see in particular articles

• Art. 37 Final report
• Art. 36 Notification of the completion, premature termination and interruption of a clinical trial
• Art. 39 Reporting in relation to the use of ionising radiation

HRO – see in particular article

• Art. 22 Notification upon completion or premature termination of a research project
• 23 Reporting of investigations involving radiation sources

Documents

• Risk Assessment Form for Clinical Rsearch Projects