What is it? Why is it important?
Routine Monitoring (RM) is carried out once participant recruitment has started until study closure or end of participant recruitment.
During RM the monitor gains oversight of study progress and site compliance to ensure that:
- The study is conducted in compliance with the study protocol, GCP, and applicable laws and regulations
- Participant rights are protected and their safety and well-being are guaranteed
- The quality and integrity of study data is guaranteed
- Expected study risks: Risks are evaluated using a risk-based approach towards study monitoring
- Type of monitoring: On-site monitoring, centralized monitoring, including a combination of both monitoring types
- Documented findings during study conduct. An increase in study findings and inconsistencies may result in an increase in monitoring activities (e.g. increase numbers of RM visits, increase of the extent of data monitoring). An unexpected increase in monitoring activities might increase the study budget
What do I need to do?
- Provides the monitor with all required documents necessary to evaluate compliance (e.g. source documents, CRFs/access to study database, filing of study documents in the ISF)
- Discusses findings with the monitor in order to find appropriate solutions. Outstanding issues from previous RM visits should be included.
- Implements corrective measures and ensures applicable staff is trained on improvement measures, applicable new processes or changes
- Outstanding issues which cannot be closed during the visit should be solved as soon as possible after the monitoring visit
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 guidelines
- 5.18. Monitoring
- 4.5. Protocol compliance
- 4.11 Safety reporting
- 6.10 Monitoring access to source data
ISO 14155:2020 Medical devices - see in particular sections (access liable to cost)
- 6.7 Monitoring Plan
- 7.3 Investigational site monitoring
- 9.2.4 Monitoring
ClinO – see in particular article
- Art. 5. Rules of good clinical practice