Your Easy Guide to Clinical Studies

Performed activities during a Routine Monitoring Visit (RMV), including recorded findings, are documented in a monitoring report.

 

The report summarises the assessment of performed monitoring activities, such as:

• The compliance with participant Informed Consent (IC) procedures (i.e. dated and signed by both study participants and Site-INV)
• The exclusive use of Ethics Committee (EC) and, if applicable, RA (e.g. Swissmedic) approved study documents (e.g. study protocol, IC / PIS forms, CRF)
• Database (CDMS) entries correspond with information recorded in the Source Data (SD) of the study
• Compliance with required safety reporting procedures (e.g. complete and timely reporting)
• The correct handling of the therapeutic product under investigation (IMP / IMD) handling (e.g. storage conditions, accountability-Log, access protected)
• The correct handling and documentation of biological material
• The documentation of protocol or ICH-GCP non-compliance
• The ongoing timely handling and correction of previously recorded findings requiring corrective measures (e.g. CAPAs)

If you are the study monitor:

• Write the RMV report and include the monitoring scope as defined in the Monitoring Plan (MP)
• Include any current and ongoing unresolved issues / findings, and provide guidelines on how to resolve them (e.g. CAPAs)
• Forward the report to the SP-INV for review and approval. Include in the report and changes made by the SP-INV
• Make sure both you, as a monitor, and the SP-INV date and sign the final 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 / e-mail summarising the visit, which is filed in the ISF.

 

In the event of remaining open issues / findings, check back with the study site at some later date. Provide any additional support needed to resolve them. Document and explain the resolution of previously open issues / findings in a subsequent interim report.

References

ICH GCP E6(R3) – see in particular guidelines

• Glossary: definition monitoring
• Glossary: definition monitoring report
• Glossary: definition monitoring plan
• 3.10.1.3 Risk control
• 3.11.4 Monitoring
• 3.11.4.5 Monitoring activities
• 3.11.4.5.1 Communication with parties conducting the trial
• 3.11.4.6 Monitoring report
• Essential records table: Site monitoring report

ICH E8 – see in particular guideline

• 6.3 Study reporting
• 6.2.1 Safety monitoring

ISO 14155 Medical Device – see in particular section (access liable to costs)

• 9.2.4.7 Monitoring reports

Documents

• Monitoring Visit Report Template