What is it? Why is it important?
The COV should be prepared carefully because it is the last visit to the site.
Activities relevant to the study must come to a close and the site must prepare for archiving.
A distinction should be made between site closure and study closure, as in multicentre studies, a particular site might close prior to the closure of the study (e.g. a site has completed its treatment of participants as specified and agreed in the SP-INV contract).
A COV can take place:
- At the regular end of the study as foreseen in the study protocol
- Due to premature closure or termination of the study
What do I need to do?
If you are the study monitor, ensure that during the COV:
- All used and unused IMP/IMD are accounted for
- Unused IMP/IMD and lab supplies are ready to be returned to the SP-INV, or the SP-INV designates unused IMP/IMD to be destroyed at the site
- All database (CDMS) queries are resolved and no more changes are possible, thus database is ready for final lock
- The end of the study is reported is to the EC and, if applicable to the RA (e.g. Swissmedic, FOPH)
- ISF and TMF filing are complete and up to date
- The Site-INV is reminded of pending responsibilities
Pending responsibilities after the study COV include:
- Data export and the statisical analysis of study results
- The archiving of study relevant study documents needed to re-construc the study
- To provide appropriate archiving premises during the entire defined archiving period (e.g. access, fire, humidity, and rodent protection)
- To ensure that archived material remains accessible and legible during the entire archiving period
- Submission of a CSR report to the EC and as applicable RA (e.g. Swissmedic, FOPH)
- The registration and publication of study results
- To be prepared for a possible audit or inspection by regulatory authorities
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
ICH GCP E6(R2) – see in particular guidelines
- 5.18 Monitoring activities
- 8.1 - 4 Filing of essential documents
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 9.2.6 Clinical investigation close-out
- Annex E: Essential clinical investigation documents
ClinO – see in particular article
- Art. 38 Notification upon study completion, discontinuation, or interruption