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

More

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

More

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):

  • Impact
  • Occurrence
  • Detectability

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

External Links

  • ADAMON – Risk-adapted monitoring

References

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

Swiss Law

ClinO – see in particular article

  • Art. 19 - 20 Study categorisation

HRO – see in particular article

  • Art. 7 Research categorisation

Documents

Abbreviations
  • CTU – Clinical Trials Unit
  • EC – Ethics Committee
  • eCRF – electronic Case Report Form
  • IT – Information Technology
  • RA – Regulatory Authorities SAE
  • RBM - Risk Based Monitoring
  • SAE - Serious Adverse Event
  • SOP – Standard Operating Procedure
  • SP-INV – Sponsor-Investigator
Development ↦ Monitoring ↦ Montoring Strategy ↦ Risk-Based Monitoring
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Development Biobanking
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Completion Biobanking
Current Path (click to copy): Development ↦ Monitoring ↦ Montoring Strategy ↦ Risk-Based Monitoring

Please note: the Easy-GCS tool is currently under construction.