Completion↦Monitoring↦Close-Out Visit↦Follow-Up Letter
What is it? Why is it important?
The monitor forwards a Follow-Up (FU) letter to the Site-INV summarizing:
- The scope of the performed COV, including a list of the performed action items (e.g. query resolution, database ready for closure, completion and filing of study documents)
- The handling of IMP/IMD and other study material
- Site archiving procedures
The FU letter can also be an email that includes all necessary information.
What do I need to do?
If you are the study monitor, write a short FU to the Site-INV and include:
- Query resolutions and completion of study data entry, with database ready for closure
- ISF tracking and the completion of essential documents needed for archiving
- Final IMP/IMD accountability, with unused products returned to SP-INV or destroyed at the site
- Lab material inventory check and leftover supply returned to SP-INV or destroyed at the site
- Definition of archiving procedures and duration, including the selection of appropriate archiving premises (e.g. access, fire, humidity, and rodent protection)
- The Site-INV files the COV follow-up letter in the ISF
- The monitor retains a copy of the letter
In the event the Site-INV is responsible for the destruction of IMP/MD or other relevant study material, an initial destruction approval letter must be forwarded from the SP-INV to the Site-INV
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
References
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)
- 9.2.4 Monitoring
- Annex E: Essential clinical investigation documents
Swiss Law
ClinO – see in particular article
- Art. 38 Notification upon study completion, discontinuation, or interruption