Your Easy Guide to Clinical Studies

During study conduct, the study monitor checks among others the quality and integrity of the study data.

 

With respect to Data Managment (DM) responsibilities, the monitor:

• Checks whether data entry is correct and recorded in a timely manner
  • Recorded entries in the database correspond to SD (original data)
  • Data entries are done in close proximity to participant visits
• Writes queries in the event of data inconsistencies or errors
• Supervises query resolution by study site  (e.g. upload of query questions, query handling by study site, query resolution or pending issues)
• Reports any inconsistencies to the SP-INV in order to define applicable corrective actions
• Checks upon subsequent monitoring visits the implementation of any outstanding corrective actions

As a SP-INV and based on the complexity of your study (e.g. study design) and expected study risks:

• Assess the monitoring requirements of your study and how it affects DM aspects
• Establish a requirement profile for a study monitor

 

Monitoring  requirements are based on study type (ClinO, ClinO-MD, HRO) and risk category (A low risk, B or C high risk). As a SP-INV define the:

• Frequency and type of monitoring (e.g. one or several spaced monitoring visits, on-site or central monitoring)
• Extent of monitoring (e.g. what data to check) and the scope of data to monitor (e.g. all collected data, only a given percentage of data)

 

For more information refer to Monitoring in this Study Guide.

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References

ICH GCP E6(R2) – see in particular guidelines

• Art. 1.38 Monitoring
• Art. 5.5 Trial Management, data handling, and record-keeping
• Art. 5.18 Monitoring activities

Swiss Law

ClinO – see in particular article

• Art. 5 Rules of Good Clinical Practice.

Documents

• Risk Assessment Form for Clinical Research Projects