Completion↦Management↦Study Closure↦Close-Out Visit
What is it? Why is it important?
Based on the MP of the study, the Close-Out Visit (COV) represents the last monitoring visit of the study. The COV thereby completes study monitoring.
The site is ready for closure once the following criteria are met:
- The last study participant has completed his/her last study visit (Last Patient Last Visit, LPLV)
- Required study data are collected and (e)CRF entries are complete
- Queries are resolved and eCRF / database irregularities are corrected
- Database is ready for final closure
- Essential documents are signed and filed in ISF and TMF and ready for archiving
Once the database is locked it can be forwarded to the statistician for analysis.
What do I need to do?
As a monitor ensure during COV that:
- Drug accountability is complete an correct, (e.g. all used or unused IMP/MD are accounted for)
- Unused IMP/MD and lab supplies are ready for return to SP-INV or to be destroyed at the site
- All CRF queries are solved with no more changes possible
- Study-end is communicated to EC and if applicable to RA
- ISF and TMF are complete and up to date
- All note-to-files are correctly filed
- Site-INV is reminded of pending responsibilities
- Archiving period is known to Site-INV (information printed on files / boxes)
For more information refer to Monitoring, Data Handling and Documents in this Study Guide.
The COV should be well prepared as it is the last visit to the site. Study relevant aspects must come to a close and the site must prepare for archiving.
Pending responsibilities after study COV include to:
- Submit a Clinical Study Report (CSR) to EC and if applicable to RA within one year
- Publish study results
- Archive study documents
- Provide appropriate archiving premises during the entire defined archiving period, (e.g. access-, fire-, humidity-, and rodent protection)
- Ensure that archiving material remains accessible and legible during the entire archiving period
- Remain prepared for the possibility of an 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
- 8.0 Essential documents for the conduct of a clinical trial
- 5.18 Monitoring activities
ISO 14155:2020 Medical devices (access liable to cost) - see in particular sections
- 8.3 Routine close out
- Annex E – Essential clinical investigation documents
ClinO – see in particular article
- Art. 38 Notification upon completion, discontinuation, interruption of study
HRO – see in particular article
- Art. 22, 36, 40, 43 Specifications regarding notification upon completion or discontinuation of a research project