Conduct↦Monitoring↦Routine Monitoring Visit↦Report
What is it? Why is it important?
The RMV report documents activities performed during monitoring, such as checking for:
- Correctly documented ICs, that are dated and signed by both study participants and Site-INV
- The use of EC and if applicable RA (e.g. Swissmedic) approved documents (e.g. the study protocol, IC, CRF)
- Database (CDMS) entries correspond to the original SD
- Complete and timely safety reporting procedures
- IMP/MD handling (e.g. storage, accountability and inventory)
- Proper handling and processing of biological material
- Potential protocol or GCP deviations
- Current and ongoing unresolved issues, including resolution measures and timelines
What do I need to do?
If you are the study monitor:
- Write the RMV report and include the monitoring scope as defined in the MP
- Include any current and ongoing unresolved issues and how to resolve them
- Forward the report to the SP-INV and include changes the SP-INV makes
- Make sure both you and the SP-INV date and sign the approved report
- File the report in the TMF
The site does not receive a copy of the RMV report. However, the Site-INV receives a follow-up letter summarising the visit, which is filed in the ISF.
If there are any open issues, check back with study site at a later date. Provide any additional support needed to resolve open issues. Document and explain the resolution of open issues in the subsequent interim report.
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
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)
- 188.8.131.52 Monitoring reports