Monitoring

Quality instead of quantity

To demonstrate that the clinical study is conducted in accordance with the clinical investigation plan, its amendments, and the applicable legal requirements, independent monitoring is essential and required for clinical investigations by the MDR, MDCG 2024-03, and ISO 14155.

The start of the study, with the inclusion of the first patient, also marks the beginning of monitoring. However, the planning of monitoring takes place in advance, depending on the study design and your requirements. Comprehensive monitoring of the study includes initiation, interim, and close-out visits. Interim visits do not always have to involve 100% source data verification (SDV) of the source data with the data in the (e)CRF. A resource-saving, adaptive approach (adaptive monitoring) can and should be considered.

At the end of the study or when closing a site, we clarify open issues, check the completeness of the Investigator Site File (ISF), and close the sites.

Throughout the entire study period, we act as an interface between you and the study sites, ensuring the quality of the study data received.

Here is an overview of what we can offer as part of monitoring:

• Recruitment of potential study sites, assessment of suitability and qualifications
• Preparation of study-specific monitoring documents such as monitoring plan  and documentation aids
• Set-up and maintenance of the ISF
• Site Initiation Visits (SIV), Interim Monitoring Visits (IMV), Close Out Visits (COV)
  • Training of personnel at the study centers
  • Comparison of the study data with the patient file (Source Data Verification, SDV)
  • Review of (serious) adverse events and incidents
  • Monitoring reports and follow-up letters after each visit
• Interface between sponsor and study centers