Conduct↦Ethics and Laws↦Study Conduct↦Ongoing Tasks
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 regulations
- Review the implemented risk strategy of the study and the efficacy of its preventative measures
- Monitor the ongoing quality of the study and its collected data (e.g. 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:
- Notify Swissmedic of the first patient enrolled in Switzerland (e.g. applicable for category B & C studies)
- Submit an Annual Safety Report (ASR) to EC, and if applicable Swissmedic
- Perform annual updates on study applicable registries
What do I need to do?
As a SP-INV and Site-INV, ensure:
- The study is conducted in compliance with the Swiss law, ICH GCP, 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. processing, storage, analysis)
- Ongoing participant safety monitoring and reporting to EC/RA, 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