Development↦Monitoring↦Montoring Strategy↦Monitoring Plan
What is it? Why is it important?
The Monitoring Plan (MP) describes the monitoring strategy of a study by defining the scope, frequency, and type of monitoring.
Important aspects to consider when defining the study MP are:
- Study complexity (e.g. randomized-, blinded-, or cross-over designs)
- The robustness of the study endpoint (e.g. an improvement in blood value versus scores in a self-assessment questionnaire)
- Expected treatment risks (e.g. use of a novel drug, participation of vulnerable participants)
- Target group (e.g. adults, children, participants without capacity)
- The number of planned study participants
Regardless of whether monitoring is on-site or centralised; the IMP gives the monitor guidance on relevant study monitoring tasks.
Prior to implementation, the IMP of a study must be submitted to the EC for approval.
A SP-INV can delegate monitoring tasks to properly trained staff. It is important that the appointed monitor is independent of the study site being monitored. Monitoring can also be delegated to a contractor/CRO/local CTU. Nonetheless, the SP-INV remains responsible for all monitoring.
The SP-INV defines in the MP:
- Visit type: on-site and/or centralised
- Visit frequency: based on study risks, site performance, and study duration
- Extent of monitoring: includes which aspects to check and to what extent (e.g. percentage of participants in the database, relevant study documents, procedures such as processing of biological samples, IMP/IMD storage, preparation of study drug)
What do I need to do?
As a SP-INV write a MP that takes into consideration the circumstances and nature of your study.
- Use a systematic, prioritised, and risk-based approach.
- Include some flexibility regarding the extent and nature of monitoring. An increase in the monitoring scope and/or number of visits at a study site might be triggered due to:
- Safety concerns
- A low recruitment rate and/or poor compliance with the study protocol
- Major fluctuations in study staff
Monitoring activities consume time and resources. Remember to include applicable adaptations in your budget.
In the MP include information on:
- Monitoring frequency. Plan more visits for high-risk studies
- The extent of study data and study documents to be monitored, such as whether to check:
- The extent of on-site and centralised monitoring
- Criteria that would trigger monitoring adaptations potentially resulting in additional on-site monitoring visit(s) (e.g. irregularities found during monitoring, such as a site with a low number of reported AEs per participant as compared to other sites)
- Potential site adaptations that might become necessary in multicentre studies
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
- 4.5 Protocol compliance
- 5.0 Quality management
- 5.18 Monitoring activities
- 6.10 Access to source data / documents
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 6.2 Risk management
- 6.7 Monitoring plan
- 7.8 Document and data control
- 9.2.4 Monitoring
ClinO – see in particular article
- Art. 19 - 20 Study categorisation
- Art. 37 – 43 Safety Reporting
HRO – see in particular article
- Art. 7 Research categorisation
- Art. 20 – 21 Safety Notification