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, guidelines, and applicable contract(s)
- 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:
- Notify Swissmedic (i.e. risk-category B & C studies) and Ethics Committee (EC) of the first patient enrolled in Switzerland (e.g. applicable for category B & C studies)
- Submit once a year a report on the safety of study participants to the EC, and Swissmedic (i.e. risk-category B & C studies)
- Perform annual updates on study applicable registries
More
Monitoring is a mandatory task for ClinO & ClinO-MD studies, but not for HRO research projects. Still even in HRO projects, data quality checks are highly recommended.
What do I need to do?
As a SP-INV and Site-INV, ensure that:
- The study is conducted in compliance with the study protocol, Swiss law, ICH GCP (ClinO), ISO 14155 (medical device studies, ClinO-MD), and the Declaration of Helsinki, and applicable contracts
- Informed consent procedures are correctly implemented and recorded (i.e. 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
- Monitoring activities conducted according to the Monitoring Plan
- 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 annual safety report
- 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 Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
External Links
Swissethics – see in particular
- Notification and reporting to the Ethics Committee
- Annual Safety Report
Swissmedic – see in particular
- BW101_20_002e_MB_Safety_of_Medicines.pdf
Swiss Law
ClinO – see in particular articles
- Art. 38 Notification to EC
- Art. 43 Reporting on the safety of participants
- Art. 57 Transplant studies - notifications and reporting
- Art. 62 Other studies - applicable provisions
- Art. 64-66 Registration