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.
Assessments during Risk-Based-Monitoring (RBM) defines the set-up of the MP. This includes among others the:
- Complexity of the study design (e.g. randomised-, blinded-, or cross-over designs)
- Robustness of the study outcome / 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 population (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 investigational therapeutic product of the study (IMP / IMD) provides the monitor with guidance on relevant study monitoring tasks that must be addressed.
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In Switzerland, the MP is a mandatory document to be submitted to the Ethics Committee (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 preparation and storage)
What do I need to do?
As a SP-INV:
- Write a MP that takes the circumstances and nature of your study into consideration
- Keep the main focus on aspects that are critical-to-quality
- 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:
- 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.
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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:
- 100% of study participant Informed Consent Forms (ICF) or less
- Full source data verification (SDV) (e.g. 100% of the data) for X% of study participants
- Partial SDV (e.g. key data only) for X% of study participants
- All AEs or only SAEs
- 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 adverse events per participant as compared to other sites)
- Potential site adaptations that might become necessary in multicentre studies
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
- Glossary: definition monitoring plan
- 3.10.1.3 Risk control
- 3.11.4 Monitoring
- 3.11.4.3 Monitoring plan
- 3.11.4.4 Monitoring procedures
- 3.11.4.5 Monitoring activities
- 3.11.4.5.4 Monitoring of clinical trial data
- 6.2 Factors critical to quality
ICH E8(R1) – see in particular guidelines
- 3. Designing quality into clinical studies
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
Swiss Law
ClinO – see in particular article
- Art. 19 - 20 Study categorisation
- Art. 37 – 43 Safety Reporting