Your Easy Guide to Clinical Studies

Study monitoring requirements are:

• Defined by the SP-INV
• Outlined in a monitoring plan

 

Monitoring:

• Is performed by a site independent monitor on behalf of the SP-INV
• Findings are documented in a monitoring report to be reviewed and approved by the SP-INV of the study
• Findings are assessed and corrective and preventive measures are implemented (quality management task)

 

A study monitor:

• Is in most cases the main line of communication between SP-INV and study site (e.g. Site -INV, study staff)
• Is independent of the study site being monitored,  including any study activities to be monitored
• Reports to the SP-INV ongoing study progress, including recorded irregularities at the study site
• Supports the study site to ensure compliance with the study protocol, ICH-GCP, and applicable Swiss law and regulations (e.g. HRA, Declaration of Helsinki, ISO 14155, ISO 20916, ISO 20387)

As a SP-INV define which Swiss law(s) is applicable to your study.

Monitoring activities are:

• Mandatory for studies conducted under the ClinO and ClinO-MD
• Possible but not mandatory for studies conducted under the HRO

 

When deciding to include a monitor in your study:

• Make sure you employ a qualified monitor
• Be aware that the monitor should work according to an SOP, that describes monitoring procedures, including respective staff responsibilities (e.g. how to plan, set up, and conduct study monitoring)

 

The SP-INV can delegate monitoring activities to a contractor/CRO/local CTU, but remains responsible for the quality of any delegated services. As agreed, the SP-INV or the delegated party is responsible to provide applicable monitoring SOPs.

References

ICH GCP E6(R3) – see in particular guideline

• Glossary: definition monitoring
• 3.11.4 Monitoring

ICH E8 – see in particular guideline

• 6.13 Data management – centralized monitoring
• 6.2.1 Safety monitoring

ISO 14155 Medical Device – see in particular section

• 9.2.4 Monitoring (access liable to costs)

Swiss Law

HRA – search for “good practice

ClinO – see in particular article

• Art. 5 Rules of GCP

ClinO-MD – see in particular article

• Art. 17d Review areas – safety monitoring