Conduct - Close-Out Visit - Monitoring - Completion - Your Easy Guide to Clinical Studies

What is it? Why is it important?

The COV should be carefully prepared because it is the last planned 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 study 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

In most cases, the COV is performed by the monitor(s) and according to the MP. However, the SP-INV can appoint other personnel 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 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 Ethics Committee (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, such as the decision regarding leftover biological material (e.g. for further-use, destroyed)

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 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(R2) – see in particular guidelines

5.18 Monitoring activities
8. Essential documents for the conduct of a clinical trial

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

Abbreviations

CDMS – Clinical Data Management System
ClinO – Clinical Trials Ordinance
COV – Close-Out-Visit
CSR – Clinical Study Report
CTU – Clinical Trials Unit
EC/RA – Ethics Committee / Regulatory Authorities
EC – Ethics Committee
eCRF – electronic Case Report Form
ICH GCP – International Council for Harmonisation Good Clinical Practice
IMD – Investigational Medical Device
IMP – Investigational Medicinal Product
ISF – Investigator Site File
ISO – International Organisation for Standardisation
MP – Monitoring Plan
RA – Regulatory Authorities
Site-INV – Site Investigator
SP-INV – Sponsor-Investigator
TMF – Trial Master File

Completion ↦ Monitoring ↦ Close-Out Visit ↦ Conduct