What is it? Why is it important?
The aim of safety reporting is to ensure that studies remain safe.
The Site-INV and SP-INV are responsible to maintain ongoing safety vigilance throughout study conduct, so as to:
- Protect participants from unnecessary risks
- Ensure the ongoing safety of the study by continuously performing benefit-risk assessments
- Provide medically relevant safety information to patients, EC, RA and MAHs, as applicable
A national reporting system ensures that safety issues and concerns are communicated on a national level. Reporting of safety issues to EC and RA is required by law.
In studies, safety monitoring, documentation and reporting:
- Is the responsibility of the Site-INV and SP-INV (e.g. Site-INV reports to the SP-INV, SP-INV reports to EC and RA)
- Have different reporting timelines depending on type and seriousness of event (e.g. within 24 hours, 7 days, 14 days, yearly safety reports)
- Are adapted in its extent based on:
- Study type (e.g. clinical (ClinO), non-clinical (HRO))
- Risk category A, B, or C
- Specifications given in the study protocol
What do I need to do?
As Site-INV and SP-INV, ensure that safety reporting is executed according to GCP, ISO, Swiss Law, and specifications given in the study protocol.
- Follow start- and end safety reporting timeframes as define in the study protocol. If not defined, required safety reporting starts after participants have signed the ICF
- Ensure reporting timelines are kept and implemented as defined by the law (e.g. Site-INV reports to SP-INV within 24 hours)
- Ensure staff is trained on safety reporting procedures
In order to protect study participants, safety issues and concerns can result in study conduct being put on hold until safety aspects are resolved.
For more information refer to Safety in this Study Guide.
As safety is supervised on an ongoing basis and applicable safety decisions must be taken, the establishment of an independent data monitoring committee is recommended. This committee, consisting of selected experts, can be consulted in order to jointly assess and decide on the best way to react to safety issues during study conduct.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, 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.usz.ch
Swissethics – see in particular
- Templates for safety notification
SCTO Platforms – see in particular
- Online safety training
Swissmedic – in particular see
- Safety measures in clinical trials
- Clinical trials with medical device
ICH GCP E6(R2) – see in particular guidelines
- 1.1 Adverse drug reaction (ADR) definition
- 1.2 Adverse Event (AE)
- 1.50 Serious adverse event (SAE) or serious adverse drug reaction (SADR)
- 4.11 Safety reporting (investigator)
- 5.17 Safety reporting (sponsor)
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 7.4 AE and Device deficiency
- 9.2.5 Safety evaluation and reporting (sponsor)
- 10.8 Safety reporting (investigator)
HRA – see in particular articles
- Art. 12 Risks and burdens
- Art. 15 Safety and protective measures
ClinO – see in particular chapters
- Chapter 2, section 5. Notification and reporting
- Chapter 3, section 4. Notifications and reporting
- Chapter 4, section 2. Notification procedures in other clinical trials
HRO – see in particular chapter
- Chapter 2, section 3. Notification and reporting