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.
Assessments during Risk-Based-Monitoring (RBM) defines the set-up of the MP. This includes among others the:
- Complexity of the study (e.g. randomised-, blinded-, or cross-over designs)
- 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)
- Number of planned study participant
Regardless whether monitoring strategy is solely on-site or combined with Central Data Monitoring (CDM); the study IMP provides the monitor with guidance on relevant study monitoring tasks that must be addressed.
In Switzerland, the MP is a mandatory document to be submitted to EC for approval. Exceptions are if the monitoring strategy is described in the study protocol, or in the Clinical Investigational Plan (e.g. medical device studies). Consequently, references to relevant paragraphs can be made.
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 activities.
The SP-INV defines in the MP:
- Visit type: on-site +/- CDM
- 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, key study data, 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, allowing for the definition of key study data
- 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:
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, Central Data Monitoring (CDM), and off-site 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