What is it? Why is it important?
Routine Monitoring Visit(s) (RMV) are carried out after the SIV and until the end of the study, or the end of participant recruitment.
During RMVs, the monitor gains an overview of study progress and site compliance. This is important in order to ensure that:
What do I need to do?
If you are the study monitor, make applicable arrangements to prepare for an upcoming RMV:
- Arrange a date for the RMV with the study site
- Based on the MP, provide a list of documents to be reviewed
- Ensure access to electronic records (e.g. study eCRF, ISF, relevant medical records)
- Estimate the time needed to complete your monitoring tasks
- Ensure that all study personnel are available for support during the RMV
Extent of study monitoring during RMVs is determined by the MP.
Request any necessary access to electronic records at the study site ahead of time, because it may take time to arrange required access rights. If local access cannot be granted, obtain applicable SD or any other necessary information in printed form.
During on-site monitoring visits, many different documents must be handled simultaneously. As a Site-INV provide the monitor with a personal work desk on the day of the visit in order to facilitate his or her work.
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
- 4.5 Protocol Compliance
- 5.18 Monitoring activities
- 6.10 Access to source data / documents
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 9.2.4 Monitoring
ClinO – see in particular article
- Art. 5 Good Clinical Practice