Your Easy Guide to Clinical Studies

Monitoring oversees the progress of a study in order to ensure that:

• Participant safety, rights, and well-being are protected
• The quality and integrity of study data is guaranteed
• Non-compliance is documented and resolved
• The study is conducted in compliance with the study protocol, SOPs, ICH GCP, Ethics requirements (EC ), applicable laws (e.g. Swiss law), applicable regulatory requirements (e.g. Swissmedic, FOPH), and applicable guidelines (e.g. ISO 14155)

The extent of monitoring is adapted according to study risk(s) and type of study under the law (e.g. ClinO versus HRO).

 

The SP-INV is responsible for the monitoring of the study, which can be delegated to the CTU or a CRO. Any delegation must be documented in a contract.

As a SP-INV:

• Select the type of monitoring required for your study (e.g. centralised, on-site, or a combination of both)
• Prepare a Monitoring Plan (MP), which documents the monitoring strategy for your study (e.g. extent and nature of monitoring)
• Appoint a monitor who
  • Has relevant scientific knowledge and experience
  • Is independent of the study
• In the event study monitoring services are outsourced, ensure to document its strategy, responsibilities, and costs in a contract

 

During a monitoring visit, the Site-INV is responsible to provide the monitor with all requested documents (e.g. quality documents) needed to perform the required Quality Control activities.

 

For more information refer to Monitoring in this Study Guide

References

ICH GCP E6(R2) – see in particular guideline

• 5.18 Study monitoring

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

• 8.2.4 Monitoring

Swiss Law

HRA – search for “good practice”

ClinO – see in particular article

• Art. 5 Rules of GCP