What is it? Why is it important?
Apart from participant recruitment, treatment and follow-up, many additional study tasks require ongoing attention.
These tasks include to:
- Ensure the study is conducted in compliance with the study protocol, applicable laws and guidelines
- Review the risk strategy of your study and the efficacy of its risk-control measures (e.g. document the review)
- Monitor the ongoing quality of the study and its collected data (e.g. routine monitoring visits)
- Ensure safety reporting requirements are correctly implemented
- Perform a risk-benefit assessment of the study, preferably once a year
- Ensure that staff remains trained on new and evolving tasks
- For ClinO studies:
What do I need to do?
- The study is conducted in compliance with the Swiss law, ICH GCP (ClinO), ISO 14155 (medical device studies, ClinO-MD), and the Declaration of Helsinki
- Informed consent procedures are correctly implemented and recorded (e.g. prior to any study relevant procedures, with special considerations regarding vulnerable participants such as children, participants without capacity, pregnant women)
- Compliance with data protection laws
- Surveillance and efficacy of the study`s implemented risk-management
- Correct handling of IMP/IMD (e.g. storage, application)
- Correct handling of Biological Material (BM) (e.g. collection, processing, storage, analysis)
- Ongoing participant safety monitoring and reporting to EC/RA (e.g. Swissmedic), including submission of an ASR
- Annual updates in applicable study registries
- Correct and current study documentation (e.g. data entry, TMF/ISF)
For more information refer to Study Management, Safety, and Quality & Risk in this study guide.
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
- Notification and reporting to the Ethics Committee
- Annual Safety Report
Swissmedic – see in particular
ClinO – see in particular articles
- Art. 64-66 Registration