Completion↦Monitoring↦Close-Out Visit↦Conduct
What is it? Why is it important?
A the Close-Out Visit (COV) is the last planned visit to a participating study site, it should be carefully prepared.
Activities relevant to the study must come to a close and the site must prepare for archiving.
A distinction should be made between the closure of a participating study site, and the closure of the study. In multicentre studies, a particular site might close prior to the closure of the study (i.e. as defined in the SP-INV contract, all site participants have completed their study treatment).
A COV can take place:
- At the regular end of the study, and as foreseen in the study protocol
- Due to premature closure or termination of the study
In most instances, the COV is performed by the monitor(s) and according to the Monitoring Plan (MP).
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For the COV, the SP-INV can appoint other personnel, than the monitor, to perform this task. In any case, the SP-INV must ensure that those performing the COV are well qualified to take over study monitoring duties.
What do I need to do?
If you are the study monitor, ensure that during the COV:
- All used and unused investigational therapeutic products, implemented in the study (IMP / IMD), are accounted for (e.g. correct and completed product accountability-log)
- Unused IMP/IMD and lab supplies are ready to be returned to the SP-INV, or destroyed at the site (i.e. requires SP-INV approval)
- 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 Ethics Committee (EC) and, if applicable. to the RA (e.g. Swissmedic, FOPH)
- ISF and TMF study filing is complete
- The Site-INV is reminded of pending responsibilities upon study closure, such as to:
- Update study registries, and support the publication of study results (e.g. final study report)
- Comply with archiving requirements (e.g. infrastructure, access protected, duration)
- Decide with the SP-INV on the handling of leftover biological material (e.g. further-use, destruction)
More
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 final or clinical study report (CSR) report to EC
- The registration and publication of study results
- To be prepared for a possible audit or inspection by regulatory authorities
- The contemplation of data sharing and further-use of leftover biological material
Where can I get help?
Your local Research Support Centre↧ can assist you with experienced staff regarding this topic
Basel, Departement Klinische Forschung (DKF), dkf.unibas.ch
Lugano, Clinical Trials Unit (CTU-EOC), ctueoc.ch
Bern, Department of Clinical Research (DCR), dcr.unibe.ch
Geneva, Clinical Research Center (CRC), crc.hug.ch
Lausanne, Clinical Research Center (CRC), chuv.ch
St. Gallen, Clinical Trials Unit (CTU), h-och.ch
Zürich, Clinical Trials Center (CTC), usz.ch
References
ICH GCP E6(R3) – see in particular guidelines
- Glossary: definition monitoring
- 3.11.4 Monitoring
- 3.11.4.5 Monitoring activities
- 3.11.4.5.1 Communication with parties conducting the trial
ICH E8 – see in particular guideline
- 6.3 Study reporting
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
Swiss Law
ClinO – see in particular article
- Art. 38 Notification upon study completion, discontinuation, or interruption