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. The study database can only be locked once the required dataset is complete (e.g. no missing data) and  all queries have been resolved
• 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.