What is it? Why is it important?
Not all studies carry the same risks. Thus, monitoring strategies can be adapted accordingly.
Adaptations may include:
- Monitoring frequency: low-risk studies require less monitoring
- Extent of monitoring: low-risk studies require less data and document checks (e.g. 20% of data versus 80%)
- Centralised versus on-site monitoring: high-risk studies may require more on-site monitoring than low-risk studies
The study SP-INV is responsible to identify risks of the study
Monitoring in low-risk studies focuses particularly on the most critical data, such as:
- Medical records that prove the existence of study participants
- IC documentation that provides evidence that all participants have agreed to participate in the study
- Data related to the primary endpoint (e.g. data on whether study treatment was successful)
- Safety documentation that demonstrates compliance with safety reporting procedures to EC and RA
- Follow-up of participants with safety issues (e.g. occurrence of an SAE)
What do I need to do?
Plan the monitoring strategy of your study by assessing risks using the CTU-RBM score calculator.
Assess risks based on:
- System-level: Risks related to IT, SOPs, and infrastructure (e.g. work and storage space, access to patient rooms, labs, resources such as budget, available time, and qualified staff)
- Study-level: risks related to type of intervention, target population, study design, data collection procedures, and safety concerns
Define thresholds that will trigger measures to reduce risks.
For more information refer to Study Quality and Risk in this Study Guide
When defining the monitoring strategy of the study, consider the following aspects:
- Complexity of design (e.g. randomized, blinded, cross-over, pilot cohort)
- Data complexity (e.g. many variables, extensive eCRF, statistical analysis)
- Study Risks (e.g. vulnerable participants, first-in-man study)
- Recruitment frequency (e.g. large numbers of participants are recruited within a short period of time)
- Number of participants (e.g. less than 20 versus several hundred)
- Number of planned monitoring visits (e.g. only an initial and final visit versus several additional intermediate visits)
- Number of participating sites (e.g. monocentric versus multicenter in Switzerland, international study)
- Existing safety data that requires increased surveillance
The CTU-RBM score calculator lists 23 potential study risks classified in 7 categories: subject, design, intervention, management, data, and others.
Each of the following risk factors is evaluated on a 3-level scale (1 = low, 2 = medium, 3 = high):
Where can I get help?
Your local CTU↧ can support you with experienced staff regarding this topic
Basel, Clinical Trials Unit, CTU, dkf.unibas.ch
Bellinzona, 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.ctc.usz.ch
- ADAMON – Risk-adapted monitoring
ICH GCP E6(R2) – see in particular guidelines
- 4.5 Protocol compliance
- 4.8 Informed consent of study participants
- 5.0 Quality management
ISO 14155 Medical Device – see in particular section (access liable to costs)
- 5.8 Informed consent
- 5.2 Risk management
ClinO – see in particular article
- Art. 19 - 20 Study categorisation
HRO – see in particular article
- Art. 7 Research categorisation