Your Easy Guide to Clinical Studies

The Annual Safety Report (ASR), also referred to in ClinO as the “periodic reporting of safety and general progress of the clinical trial”, summarises the current progress and safety information of an ongoing study.

 

An ASR report is submitted:

• For all studies under ClinO and ClinO-MD
• Once a year to the Ethics Committee (EC) and, if applicable, Swissmedic (i.e. only for risk-category B and C studies)

 

The ASR report:

• Summarises the current recruitment/general progress status of the study
• Contains, from all participating study sites, a list of relevant safety events, that occurred:
  • Since the last submitted ASR, or
  • Upon 1 year following study start (e.g. defined as the EC/Swissmedic approval date, whichever came first)
• Describes the safety assessments of collected events (e.g. severity, seriousness, causal relationship to the intervention, and expectedness)
• Describes the implemented risk-control measures needed to protect study participants

Mehr

As a Site-INV submit all safety relevant information required for the preparation of the ASR report to the SP-INV.

As a SP-INV submit once a year an ASR to:

• All participating Site-INV(s)
• EC via BASEC (e.g. use a safety form)
• Swissmedic (for risk category B and C studies)

 

Based on study type, include in your ASR the following lists:

• Investigational Medicinal Product (IMP) studies: all SAEs and SUSARs
• Investigational Medical Device (IMD) studies: all reportable events (SADEs and DDs with SAE potential)
• Other Clinical Trials: all SAEs for which a causal relationship with the intervention cannot be excluded
• TrP / GT / GMO studies: all SAEs, SADRs, SUSARs, and quality defects

 

For international multi-centre studies with TrP/ GT / GMO:

• Present data from study participants treated in Switzerland separately
• For healthy volunteers, list all AEs irrespective whether they occurred in Switzerland or abroad

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

Swiss Law

ClinO – see in particular article

• Art. 43 Reporting on the safety of participants

ClinO-MD – see in particular article

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