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:

  • The safety, rights, and well-being of study participants are being protected
  • The quality and integrity of study data are maintained
  • The study is conducted in compliance with the study protocol, GCP, and applicable laws and regulations

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.

More

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

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 Monitoring

Swiss Law

ClinO – see in particular article

  • Art. 5 Good Clinical Practice
Abbreviations
  • CTU – Clinical Trials Unit
  • eCRF – electronic Case Report Form
  • ISF –Investigator Site File
  • GCP – Good Clinical Practice
  • MP – Monitoring Plan
  • SD – Source Data
  • Site-INV – Site Investigator
  • SIV – Site Initiation Visit
  • RMV – Routine Monitoring Visit
Conduct ↦ Monitoring ↦ Routine Monitoring Visit ↦ Preparation
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 ↦ Preparation

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