Your Easy Guide to Clinical Studies

A study is closed once the last study participant has had his/her last study visit.

 

Upon study closure, various activities are implemented, such as:

• To conduct a monitoring close-out visit
• To conclude IMP management (e.g. accountability, return to SP-INV, destruction)
• To ensure that all participant (S)AEs are correctly documented and closed (e.g. resolved or stabilised)
• To lock the study CDMS (eCRF) and to export the data for statistical analysis
• To inform the EC and if applicable RA (e.g. Swissmedic) about study closure (e.g. and if applicable also study participants)
• To write and submit a clinical (final) study report to EC and if applicable RA
• To update all required registries (e.g. international public registry, federal database)
• To publish study results (e.g. scientific publications)
• To prepare study documents for archiving (electronic and hard copies)

As a SP-INV and Site-INV complete and finalize upon study closure the document management of your study:

• Date and sign the study CRF (electronic and paper)
• Complete the finalise the filing of all essential and relevant quality documents in the study TMF/ISF

 

Complete the filing of all relevant study logs and ensure they are all dated and signed (e.g. identification-, delegation-, IMP accountability-, monitoring visit log)

Prepare documents for archiving and establish a document filing system that guarantees document identification and traceability. This will allow for easy document retrieval at some later date.

At study closure, left over study IMP/IMD is either destroyed or returned to the SP-INV of the study.