Regulatory Submissions Progress Dashboard

July 16, 2024

Building high-quality regulatory submissions takes a large amount of resources and requires the coordination of many stakeholders throughout the process. Monitoring key progress indicators (KPI) throughout the data generation and submission compilation process is key to understanding if resources are being properly allocated. One metric will not provide a holistic view of progress but in aggregate these measures can provide insight. I created a KPI Category, Metric, Value score system that attempts to quantify these input and output variables. Here is an exemplar matrix of 24 KPI metrics used to build out the dashboard. The web output is here. 

Here are the "scoring" system explanations.

The Value column represents the actual metrics or measurements for each KPI. These values are what you will use to generate the visualizations for the dashboard. Here's a breakdown of what each value represents:

Documentation and Data Collection

• Completion Rate of Required Documentation: 95% (indicating that 95% of the required documentation is completed)

• Data Accuracy and Integrity checks: 8 (indicating 8 successful data accuracy and integrity checks)

• Submission of Third-Party Studies: 5 (indicating 5 third-party studies have been submitted)

Study Design and Execution

• Study Protocol Approvals: 12 (indicating 12 study protocols have been approved)

• Completion Rate of Studies: 60% (indicating that 60% of the studies are completed)

• Data Analysis Progress: 45% (indicating that 45% of the data analysis is completed)

Regulatory Compliance

• Deficiency Resolution Rate: 95% (indicating that 95% of identified deficiencies have been resolved)

• Compliance Checks: 15 (indicating 15 compliance checks have been conducted)

Cross-Disciplinary Coordination

• Meeting Frequency and Attendance: [3, 4, 2, 5] (indicating the number of meetings attended per week over four weeks)

• Interdisciplinary Communication: 7 (indicating 7 instances of interdisciplinary communication)

• Issue Resolution Time: 10 (indicating the average time taken to resolve issues, in hours or days)

Timeline and Milestones

• Adherence to Timeline: 80% (indicating 80% adherence to the project timeline)

• Milestone Achievement: 6 (indicating 6 milestones have been achieved)

• Review Cycle Progress: 4 (indicating progress in the review cycle)

Quality Assurance

• Document Review and Approval Rate: 95% (indicating that 95% of documents have been reviewed and approved)

• Audit Findings: 2 (indicating 2 audit findings)

• Quality Control Checks: 10 (indicating 10 quality control checks have been conducted)

Submission Preparation

• Template Population Progress: 65% (indicating 65% progress in populating submission templates)

• Final Review and Clearance: 8 (indicating 8 final reviews and clearances)

Stakeholder Engagement

• Stakeholder Feedback Sessions: 5 (indicating 5 stakeholder feedback sessions have been conducted)

• Training and Workshops: 6 (indicating 6 training sessions and workshops have been conducted)

Resource Allocation

• Budget Adherence: 95% (indicating 95% adherence to the project budget)

• Resource Utilization: 95% (indicating 95% of resources have been utilized)

• Time Tracking: [40, 42, 45, 47] (indicating hours or effort spent per week over four weeks)