Completion↦Documents↦Required Documents↦Study Closure
What is it? Why is it important?
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)
What do I need to do?
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.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch