RBQM Maturity Self-Assessment

For each dimension, select the maturity level that best reflects your organization today

Use the definitions below each option to align stakeholders, identify areas for improvement, and guide next steps conversations

The scoring summary at the end is intended as a directional conversation starter, not an audit or compliance determinant

Planning

1 Rarely

2 Sometimes

3 Often

4 Always

Initial protocol risk assessment

No formal risk assessment

Risk assessments are conducted for a few studies only

Risk assessments are conducted for most studies with some variability

Risk assessments are conducted systematically for all studies prior to protocol finalization

Risk Assessment Categorization Tool (RACT) integration into functional plans

No connection between risks and functional activities

Limited connection between risks and functional plans

Most prioritized risks have connections with multiple functional plans

All relevant prioritized risks have connections to the functional plans. All functional plans reflect the RACT risk strategy

Defined risk monitoring activities

No risk-based monitoring and review strategy

Monitoring and review are defined ad hoc

Monitoring and review are driven by the risks across most studies and include a clear connection with study metrics (KRI, KPI, KQI, etc.) whenever applicable

Monitoring and review activities are fully and consistently aligned with the risks. Metrics and thresholds are well defined and documented

Defined mitigations and controls

No predefined mitigations. Lack of consistent risk control strategy

Mitigations are created reactively. Risk controls are subjective

Mitigations are consistent. Risk control strategy is driven by a risk scoring model and defined thresholds

Mitigations and controls are consistently conducted for all studies. Both are well defined, proactively identified, and maintained

Cross-functional alignment on risks

Risk assessment is not completed or is completed in silos. Risk ownership is not defined

Alignment on and ownership of risks is limited and occurs inconsistently

Alignment on and ownership of risks is defined and conducted for most studies

Risk assessment includes a full cross-functional team, and clear ownership is defined for prioritized risks

Execution & Closeout

1 Rarely

2 Sometimes

3 Often

4 Always

Risk-based data review

A full data review is conducted without considering a risk-based approach

A full data review is conducted with occasional risk considerations

Data review is risk-based for most data and most studies

Risk consistently drives all data review activities focusing on critical areas as defined during planning and re-review

Criticality incorporated into review

No critical data is identified, or connected to review activities

Data criticality is assessed inconsistently or rarely connected with review activities

Data criticality across multiple tiers is consistently assessed for most studies and drives review activities

Review activities focus on areas of greatest risk, aligned with data criticality, with resources prioritized accordingly

Metadata included in data review

Metadata is not reviewed

Metadata review is occasional or used for isolated issues

Metadata review is incorporated into review activities across multiple functions

Metadata review is driven by the previously identified risks and consistently conducted across all studies

Continuous reassessment

No reassessment is performed

Reassessment is conducted after major issues occur

Risks are re-assessed periodically and proactively

Reassessment occurs at minimum defined frequency, with out-of-sequence reviews when necessary

Source Data Verification (SDV) / Source Data Review (SDR) reduction

100% SDV/SDR approach is maintained

SDV/SDR reduction is attempted inconsistently, SDV is minimally reduced

SDV/SDR reduction is driven by the risk assessment and applied in most studies

Risk-based SDV/SDR is consistently applied across all studies, with SDV expected to be minimal unless risk dictates otherwise

Oversight

1 Rarely

2 Sometimes

3 Often

4 Always

Process oversight

There is no formal cross-study or outsourced activities oversight

Oversight exists inconsistently or informally

Cross-study oversight is defined for most processes including the ones that are outsourced

Formal and consistent cross-study oversight is conducted for most of the relevant GCP processes

Escalation pathways

No escalation process is defined

Escalation is handled reactively and inconsistently

Escalation pathways are conducted most of the time and follow documented processes

Clear escalation pathways are consistently defined, measured, and followed

Continuous improvement

No improvement process. No lessons learned

Improvements are rare and made reactively. Lessons learned are captured occasionally

Improvement initiatives occur periodically. Lessons learned are captured, reviewed, and distributed occasionally

Continuous improvement is embedded in governance, with lessons learned incorporated into future studies and processes

Governance

No governance framework

Governance is inconsistently applied and reactive

A governance mechanism is established but conducted inconsistently

Governance fully supports RBQM strategy across portfolio and is applied to both planning and execution

Score Summary

Planning0 / 20

Execution & Closeout0 / 20

Oversight0 / 16

Total0 / 56

14-24

Early-stage readinessFoundational RBQM practices may be informal, siloed, or inconsistently applied

25-38

Developing readinessCore activities are emerging, and there are clear opportunities to standardize and ensure inspection readiness

39-49

Established readinessRBQM practices are broadly in place, and there are opportunities to strengthen consistency, measurement, and governance

50-56

Advanced readinessRBQM is embedded across planning, execution, and portfolio oversight

What Does Your Assessment Reveal?

Regardless of your score, every organization has opportunities to improve how risk is identified, monitored, and managed throughout the clinical trial lifecycle.

Use your results to interpret current readiness, benchmark your current approach, and explore opportunities for more intelligent risk management.

About elluminate RBQM

elluminate RBQM is part of the elluminate Clinical Data Intelligence Platform and supports proactive identification and management of protocol, process, and vendor risk at both the study and portfolio levels.