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 participants and Site-INV
  • The use of EC and if applicable RA approved documents (e.g. the study protocol, IC, CRF)
  • Database 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

More

  • The site does not receive a copy of the RMV report. However, the Site-INV receives a follow-up letter summarising the visit
  • 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

References

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)

  • 9.2.4.7 Monitoring reports

Documents

Abbreviations
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • GCP – Good Clinical Practice
  • IC – Informed Consent
  • IMP/MD – Investigational Medicinal Product/Medical Device
  • MP – Monitoring Plan
  • RA – Regulatory Authorities
  • RMV – Routine Monitoring Visit
  • SD – Source Data
  • Site-INV – Site Investigator
  • SP-INV – Sponsor-Investigator
  • TMF – Trial Master File
Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Report
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Report

Please note: the Easy-GCS tool is currently under construction.