What is it? Why is it important?
Off-site monitoring (e.g. or remote monitoring), relates to monitoring activities where the monitor contacts the study site through e-mail, telephone, or conference calls. The aim is to:
- Assess the progress of the study site (e.g. current number of included or planned study participants)
- Track / address monitoring issues (e.g. resolution of queries, study staff fluctuations, status of data entry)
- Prepare the site for an on-site visit (e.g. set a date, inform about planned monitoring activities, staff support by the site)
The monitor checks documents (e.g. copies) provided by the site, and/or discusses relevant study procedures (e.g. informed consent procedures).
Due to data protection laws, documents provided by the site must not contain any participant identifiers (e.g. name, DOB, address). Regulators do not normally allow the remote checking of patient files (e.g. participant medical records) as the complete de-identification of documents is considered too challenging.
What do I need to do?
As a monitor, define off-site monitoring tasks such as to remotely:
- Review copies of study documents (e.g. site delegation log, drug accountability logs, IMP/IMD storage temperature logs)
- Discuss study procedures (e.g. participant consenting procedures, the exclusive use of EC/RA (e.g. Swissmedic) approved documents, ongoing adherence to safety reporting requirements)
Regarding study monitoring services, off-site monitoring activities should be included in the study budget. Likewise other monitoring activities (e.g. on-site- and central data monitoring), off-site monitoring checks should be included in the study monitoring plan.
Certain aspects can only be monitored through on-site monitoring, such as:
- ICF checks needed to confirm that all recruited participants did date and sign the document
- Process checks needed to confirm the correct handling and monitoring of investigational product (e.g. IMP/IMD preparation, storage, ongoing inventory, implementation of an emergency plan in the event of freezer breakdown)
- Patient file checks needed to verify that:
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
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 9.2.4 Monitoring