Your Easy Guide to Clinical Studies

The Annual Safety Report (ASR) is also referred to in:

• ClinO as a “Periodic Safety and general Progress Report”
• ClinO-MD as a Clinical Investigation Report (CIR)
• ICH GCP as a “Clinical trial / Study report” (CSR)

 

The aim of an annual safety/progress report is to provide a summary of the current progress and safety information of an ongoing study.

 

A report:

• Summarises the current recruitment/general progress of the study
• Includes a list of relevant safety events including their safety assessment (from all participating study sites):
  • Since the last submitted ASR, or
  • After 1 year following study start (i.e. defined as the Ethics Committee (EC)/Swissmedic approval date, whichever came first)
• Includes an assessment of the study`s implemented Quality by Design approach, with a description of:
  • Risks threatening the study`s Critical to Quality factors
  • Implemented risk-control measures needed to protect the safety of study participants, and the quality of study data

As a Site-INV submit to the SP-INV:

• A list and description of the site`s safety events (e.g. severity, seriousness, causal relationship to the intervention, and expectedness assessed by the SP-INV)
• Specifications regarding potential safety concerns
• Applicability and efficacy of implemented risk control measures against risks threatening the study`s Critical to Quality factors

 

As a SP-INV, prepare a report and:

• Describe the progress of the study (e.g. participant inclusion)
• Include a summary of all collected safety events from participating study sites. Include safety events from studies abroad conducted under the same protocol
• Include results from an interim analysis, and explain any deviation from the Statistical Analysis Plan
• Describe the compliance with the study`s Quality by Design approach

 

As a SP-INV submit once a year, a report to:

• The Ethics Committee (EC) via BASEC portal
• Swissmedic risk-category B and C studies, via Swissmedic portal
• All participating Site-INV(s)

 

As applicable, update relevant registries to promote research transparency

Mehr

External Links

Swissethics – see in particular

• Templates and checklists / Notifications
  • Annual Safety Report

Swissmedic – see in particular

• Human medicine
  • Clinical trials on medicinal products
  • Safety measures in clinical trials
• Medical devices
  • Clinical trials
  • Submissions during ongoing clinical trials

References

ICH GCP E6(R3) – see in particular guideline

• 3.17.2 Clinical trial / Study report
• 6.2 Factors critical to quality
• 7.3 Management of CtoQ factors

ICH E8(R1) – see in particular

• Glossary: definition of a CSR
• 3.2 Critical to quality factors
• 3.3 Approach to identify CtoQ factors
• 5.6 Statistical analysis

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

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

Swiss Law

ClinO – see in particular article

• Art. 43 Reporting on the safety of participants
• Art. 57b Reporting on the safety of participants
• Art. 62d Applicable provisions

ClinO-MD – see in particular article

• Art. 35 Annual reporting on the safety of participants
• Art. 38 Notification and reporting to Swissmedic