Your Easy Guide to Clinical Studies

The Close-Out Visit (COV) is the last monitoring visit and thus completes the monitoring aspect of the study.

The site is ready for closure once the following criteria are met:

• The last study participant has completed his or her last study visit
• All required study data has been collected and all eCRF entries in the study database (CDMS) are complete
• Queries have been resolved and database irregularities have been corrected. Thus the study database is ready for closure
• Essential documents have been dated and signed and filed in either ISF and/or TMF and consequently ready for archiving

 

Once the study database has been closed (locked), the data can be exported and forwarded to the statistician for analysis.

Confer with the study monitor and the study site in order to determine if closure criteria are fulfilled, and the site is ready for the COV.

Consult with the site to schedule the COV and inform the site of:

• The estimated time required
• Documents that need to be reviewed prior to archiving
• Required access to electronic records
• Which staff must be present in order to complete study closure (e.g. Site-INV, responsible study nurse)

 

Make sure that the Site-INV has sufficient time for a final discussion. During this discussion, a retrospective analysis of study performance can be summarised (e.g. lessons learned).

 

Lessons learned should be recorded because they provide important guidance for subsequently potential future studies.

 

Ideally, the COV is conducted after database lock. Also, potentially one could combine a Routine Monitoring Visits (RMV) with a COV, although this is not recommended

References

ICH GCP E6(R2) – see in particular guidelines

• 5.18 Monitoring activities
• 8. Essential documents for the conduct of a clinical trial

 

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

• 9.2.4 Monitoring
• Annex E: Essential clinical investigation documents