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 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.
Experienced staff at your local CTU can provide you with support on this topic.
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
- CDMS - Clinical Data Management System
- CRF – Case Report Form (p – paper; e – electronic)
- CTU – Clinical Trials Unit
- EC/RA – Ethics Committee / Regulatory Authorities
- IMP – Investigational Medicinal Product
- ISF – Investigator Site File
- (S)AE – (Serious) Adverse Event
- Site-INV – Site Investigator
- SP-INV – Sponsor Investigator
- TMF – Trial Master File