What is it? Why is it important?
The COV report documents activities performed during the COV, such as:
- Recording of staff attendance
- Final check of ISF and essential documents in order to prepare for document archiving
- Final IMP/IMD and study material accountability check
- Left over IMP/IMD ready to be returned and destroyed by the SP-INV, or the SP-INV delegates destruction tasks to the Site-INV
- Final query resolution, with database (CDMS) ready to be locked, so as no more changes are possible
- Study data ready for export and data analysis
- The selection of appropriate archiving premises able to safeguard archived documents over the entire archiving period
After the COV is completed, all previously unresolved issues should be resolved. If issues are still pending, a follow-up COV would become necessary. The SP-INV and monitor must ensure that there are no unresolved issues after the final COV.
What do I need to do?
As the study monitor who performs the COV, write its report and include a list of resolved issues, such as:
- Queries resolved
- ISF filing completed
- Database locked
- IMP/IMD returned to SP-INV or destroyed at the site
- Archiving premises selected
- EC and of applicable RA (e.g . Swissmedic) informed about the end (or termination) of the study
Forward the report to the SP-INV for review and include your comments. Incorporate any relevant SP-INV changes into the report. Together with the SP-INV date and sign the COV report, and file it in the TMF. The site does not receive a copy of the COV report. However, the Site-INV receives a follow-up letter summarising the visit and to be filed in the ISF.
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)
- 184.108.40.206 Monitoring reports
- Annex E: Essential clinical investigation documents
ClinO – see in particular article
- Art. 38 Notification upon study completion, discontinuation, or interruption