Free RBQM Readiness Assessment | Evaluate Your Organization

Does your organization have a documented RBQM strategy aligned with ICH E6(R3)?

No strategy

No documented RBQM approach

In development

Strategy being drafted

Documented

Strategy exists but not fully implemented

Fully implemented

Strategy documented and actively used

How mature is your KRI (Key Risk Indicator) program?

No KRIs

No KRIs defined or tracked

Basic KRIs

Using vendor defaults only

Custom KRIs

Custom KRIs designed for your trials

Optimized KRIs

KRIs tuned with thresholds validated against your data

What percentage of your monitoring is centralized vs. on-site?

0-25% centralized

Primarily on-site monitoring

25-50% centralized

Some centralized monitoring

50-75% centralized

Majority centralized monitoring

75-100% centralized

Predominantly centralized with risk-based on-site

How integrated is your clinical trial data ecosystem?

Siloed systems

No integration between EDC, ePRO, Safety DB, IRT

Manual integration

Data manually reconciled across systems

Partial integration

Some automated data feeds

Fully integrated

Real-time data integration across all systems

Do you have an RBQM platform in place?

No platform

Using Excel and manual processes

Platform purchased

Platform licensed but not yet implemented

Platform implemented

Platform live but low adoption

Platform optimized

Platform fully adopted and delivering value

How do you handle data quality monitoring?

Reactive

Issues found at database lock

Periodic checks

Monthly or quarterly data quality reviews

Weekly monitoring

Weekly data quality reports

Real-time monitoring

Automated daily data quality checks with alerts

What is your team's RBQM training level?

No training

No formal RBQM training

Basic awareness

One-time vendor training during implementation

Role-based training

Ongoing training for specific roles

Continuous learning

Regular training, refreshers, and knowledge sharing

How do you validate your RBQM systems?

No validation

Systems not validated

Vendor validation

Relying on vendor validation only

CSV approach

Traditional Computer System Validation

CSA approach

Risk-based Computer Software Assurance (CSA)

Do your RBQM insights drive action?

No action

Reports generated but not acted upon

Occasional action

Some risk signals trigger action

Documented process

Clear SOPs for responding to risk signals

Closed-loop system

Actions tracked and effectiveness measured

How do you measure RBQM program success?

No metrics

No measurement of RBQM effectiveness

Basic metrics

Tracking KRI counts and alerts

ROI tracking

Measuring cost savings and efficiency gains

Comprehensive metrics

ROI + quality outcomes + regulatory readiness

RBQM Readiness Assessment