What is it? Why is it important?
Safety assessments (SAs) of Other Clinical Trials (OCT) are standardised procedures used to evaluate adverse events (AEs), and other reportable events, during study conduct.
In OCT studies, SA of AEs is based on 3 main criteria:
- Severity: grades the intensity of an AE, such as:
- CTCAE, criteria mainly used in oncology
- Other grading systems. Such as to distinguish between mild, moderate, and severe AEs (ICH E2A)
- Seriousness: grades the effective harm of an AE to study participants. The grading is based on clear regulatory definitions (e.g. serious / non-serious)
- Causality: assesses the suspected relationship between study intervention and AE occurrence
- Mild: minor discomfort which does not interfere with normal daily activity
- Moderate: discomfort which reduces or affecting normal activity
- Severe: incapacitating with the inability to work or perform normal daily activities
For OCT, serious is defined as any event which:
- Requires inpatient treatment not envisaged in the protocol or extends a current hospital stay
- Results in permanent or significant incapacity or disability
- Is life-threatening or results in death; or
- Causes a congenital anomaly or birth defect
- Is a congenital anomaly/birth defect
Suggested assessment (according to Art. 63 ClinO):
- It can be excluded that the SAE is attributable to the intervention under investigation
- It cannot be excluded that the SAE is attributable to the intervention under investigation
What do I need to do?
As a Site-INV assess each AE and:
- Determine its severity (e.g. intensity) as defined in the study protocol
- Determine whether the AE qualifies as serious. A serious AE is named a Serious Adverse Event (SAE)
- Determine if there is a relationship between study intervention and AE occurrence
As a SP-INV:
- Re-assess each AE reported by the Site-INV(s) on severity, seriousness, and relationship
- Report safety events as required by applicable laws (e.g. to EC)
- If applicable, re-evaluate the risk-benefit of the study
- Inform the Site-INV
For all AEs, Site-INV and SP-INV both assess severity (intensity), seriousness, and causality.
In the event the SP-INV and Site-INV disagree on the assessment, they should try to find a consensus. If not possible, the opinion of both Site-INV and SP-INV should be included in the report.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.ctc.usz.ch
ICH GCP E6(R2) – see in particular guideline
- 6.8 Assessment of Safety
FEDLEX – law is available online under number
- 810.305 ClinO
ClinO – see in particular article
- Art. 63 Documentation and notification of SAE