Clinical Risk Toolkit

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Manage Clinical Risk: servant leader that mentors the project team (marketing, product, tech, analytics) and business leaders in optimizing agile processes toward maximum business value while fostering an inclusive culture.

More Uses of the Clinical Risk Toolkit:

  • Contribute to overall Early Clinical Development Knowledge Management Strategy and execution.

  • Provide advice and Network Administration for the Clinical Technology Services staff in support of departmental operations.

  • Confirm your organization supports standardization initiatives as identified by Supply Chain leadership to Reduce Costs, to achieve Operational Efficiency, and to ensure clinical availability of supplies.

  • Ensure you establish; lead development of Statistical Analysis plans for clinical trials and research studies; perform sample size calculations.

  • Identify Privacy Risk areas, particularly in the area of clinical research, conduct focused privacy review, conduct trending analysis, and direct facility/departments to implement Corrective Action.

  • Coordinate with clinical team members to ensures all technology resources support your clinical goals and objectives while ensuring the Business Needs are met.

  • Confirm your organization ensures compliance with organization standards related to clinical measurement programs transparency, data exchange, ethics and public reporting.

  • Lead the development of prototype 3D recognition systems that scale to large clinical datasets.

  • Secure that your design complies; partners with clinical leaders in the effective adoption of information technology solutions in support of research and education.

  • Provide clinical input to Engineering, Manufacturing and Field Service regarding equipment performance and new product specifications.

  • Guide Clinical Risk: work directly with Business Development, research, clinical development, and commercial personnel to ensure the incorporation of key insights into the development of project strategy.

  • Make sure that your enterprise develops, evaluate, plans and conducts analysis of financial, operational, clinical or administrative projects in collaboration with management.

  • Secure that your organization conducts an evaluation of members/clients needs and benefit plan eligibility and facilitates integrative functions using clinical tools and information/data.

  • Prepare detailed audit reports and work with clinical and Quality Managers in the program to improve Data Quality.

  • Engage and inspire the clinical science team by consistently communicating the strategic vision, the operational plan to achieve the vision and by modeling the effort it takes to accomplish a successful product.

  • Guide Clinical Risk: clinical department draw on specialized knowledge gained from professional practice.

  • Create comprehensive, high impact content and Engagement Plans to maximize uptake, in collaboration with Product, Performance, and Clinical Strategy.

  • Advise and consult Clinical Development leadership and research teams of Inspection risk, clinical quality and compliance related issues, and support development and implementation of QMS/inspection Risk Mitigation.

  • Warrant that your enterprise provides clinical consultative services in accordance with contracted clinical services.

  • Identify opportunities to improve clinical and Administrative Processes.

  • Be accountable for spreading appropriate clinical knowledge about the market and feeding clinical study insight from the market back into your organization.

  • Manage Clinical Risk: work in the Research and Development department to establish and lead efforts aimed at assuring proper design and timely execution of development, analytical, and clinical diagnostic studies.

  • Be accountable for providing technical leadership and developing technical depth specifically related to clinical study viability and design and to also provide guidance on ways to gain competitive advantage through clinical study initiatives.

  • Establish Clinical Risk: operational and clinical Performance Improvement decision support, Data Analysis, and facilitating teams with Process Improvement methods.

  • Secure that your operation coordinates the installation of applications, modification, enhancements, and deployment of new portions of the EMR with specified clinical locations with minimal disruption to users.

  • Govern Clinical Risk: implement and execute enterprise level, cross departmental collaboration to align understanding and set priorities on clinical and business solutions Data Integration and Application Development.

  • Identify market and product trends and provide that feedback to the Clinical Sales management.

  • Warrant that your corporation complies; principles and techniques of clinical interviewing, diagnosis, and treatment.

  • Warrant that your organization demonstrates Leadership Skills in managing resources and data related to administrative and Clinical Operations, establishing and sustaining effective interdisciplinary relationships, and promoting Effective Communication and optimal Customer Service.

  • Provide statistical programming support to the project team for analysis and reports of clinical data in early clinical research studies.

  • Analyze and understand insurable risks and potential Risk Mitigation opportunities; interact with operational groups to ensure coordination between project activities, exposures, and appropriate insurance coverage.

  • Be accountable for developing Mathematical Models to solve difficult stochastic problems.


Save time, empower your teams and effectively upgrade your processes with access to this practical Clinical Risk Toolkit and guide. Address common challenges with best-practice templates, step-by-step Work Plans and maturity diagnostics for any Clinical Risk related project.

Download the Toolkit and in Three Steps you will be guided from idea to implementation results.

The Toolkit contains the following practical and powerful enablers with new and updated Clinical Risk specific requirements:

STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Clinical Risk Self Assessment book in PDF containing 49 requirements to perform a quickscan, get an overview and share with stakeholders.

Organized in a Data Driven improvement cycle RDMAICS (Recognize, Define, Measure, Analyze, Improve, Control and Sustain), check the…

  • Example pre-filled Self-Assessment Excel Dashboard to get familiar with results generation

Then find your goals...

STEP 2: Set concrete goals, tasks, dates and numbers you can track

Featuring 999 new and updated case-based questions, organized into seven core areas of Process Design, this Self-Assessment will help you identify areas in which Clinical Risk improvements can be made.

Examples; 10 of the 999 standard requirements:

  1. Who will be responsible for deciding whether Clinical Risk goes ahead or not after the initial investigations?

  2. Is risk periodically assessed?

  3. Are all Key Stakeholders present at all Structured Walkthroughs?

  4. What defines best in class?

  5. What are the disruptive Clinical Risk technologies that enable your organization to radically change your business processes?

  6. Where can you get qualified talent today?

  7. Is it needed?

  8. How do you foster the skills, knowledge, talents, attributes, and characteristics you want to have?

  9. How is Continuous Improvement applied to Risk Management?

  10. What are the barriers to increased Clinical Risk production?

Complete the self assessment, on your own or with a team in a workshop setting. Use the workbook together with the self assessment requirements spreadsheet:

  • The workbook is the latest in-depth complete edition of the Clinical Risk book in PDF containing 994 requirements, which criteria correspond to the criteria in...

Your Clinical Risk self-assessment dashboard which gives you your dynamically prioritized projects-ready tool and shows your organization exactly what to do next:

  • The Self-Assessment Excel Dashboard; with the Clinical Risk Self-Assessment and Scorecard you will develop a clear picture of which Clinical Risk areas need attention, which requirements you should focus on and who will be responsible for them:

    • Shows your organization instant insight in areas for improvement: Auto generates reports, radar chart for maturity assessment, insights per process and participant and bespoke, ready to use, RACI Matrix
    • Gives you a professional Dashboard to guide and perform a thorough Clinical Risk Self-Assessment
    • Is secure: Ensures offline Data Protection of your Self-Assessment results
    • Dynamically prioritized projects-ready RACI Matrix shows your organization exactly what to do next:


STEP 3: Implement, Track, follow up and revise strategy

The outcomes of STEP 2, the self assessment, are the inputs for STEP 3; Start and manage Clinical Risk projects with the 62 implementation resources:

  • 62 step-by-step Clinical Risk Project Management Form Templates covering over 1500 Clinical Risk project requirements and success criteria:

Examples; 10 of the check box criteria:

  1. Cost Management Plan: Eac -estimate at completion, what is the total job expected to cost?

  2. Activity Cost Estimates: In which phase of the Acquisition Process cycle does source qualifications reside?

  3. Project Scope Statement: Will all Clinical Risk project issues be unconditionally tracked through the Issue Resolution process?

  4. Closing Process Group: Did the Clinical Risk project team have enough people to execute the Clinical Risk project plan?

  5. Source Selection Criteria: What are the guidelines regarding award without considerations?

  6. Scope Management Plan: Are Corrective Actions taken when actual results are substantially different from detailed Clinical Risk project plan (variances)?

  7. Initiating Process Group: During which stage of Risk planning are risks prioritized based on probability and impact?

  8. Cost Management Plan: Is your organization certified as a supplier, wholesaler, regular dealer, or manufacturer of corresponding products/supplies?

  9. Procurement Audit: Was a formal review of tenders received undertaken?

  10. Activity Cost Estimates: What procedures are put in place regarding bidding and cost comparisons, if any?

Step-by-step and complete Clinical Risk Project Management Forms and Templates including check box criteria and templates.

1.0 Initiating Process Group:

2.0 Planning Process Group:

  • 2.1 Clinical Risk Project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 Clinical Risk project Scope Statement
  • 2.7 Assumption and Constraint Log
  • 2.8 Work Breakdown Structure
  • 2.9 WBS Dictionary
  • 2.10 Schedule Management Plan
  • 2.11 Activity List
  • 2.12 Activity Attributes
  • 2.13 Milestone List
  • 2.14 Network Diagram
  • 2.15 Activity Resource Requirements
  • 2.16 Resource Breakdown Structure
  • 2.17 Activity Duration Estimates
  • 2.18 Duration Estimating Worksheet
  • 2.19 Clinical Risk project Schedule
  • 2.20 Cost Management Plan
  • 2.21 Activity Cost Estimates
  • 2.22 Cost Estimating Worksheet
  • 2.23 Cost Baseline
  • 2.24 Quality Management Plan
  • 2.25 Quality Metrics
  • 2.26 Process Improvement Plan
  • 2.27 Responsibility Assignment Matrix
  • 2.28 Roles and Responsibilities
  • 2.29 Human Resource Management Plan
  • 2.30 Communications Management Plan
  • 2.31 Risk Management Plan
  • 2.32 Risk Register
  • 2.33 Probability and Impact Assessment
  • 2.34 Probability and Impact Matrix
  • 2.35 Risk Data Sheet
  • 2.36 Procurement Management Plan
  • 2.37 Source Selection Criteria
  • 2.38 Stakeholder Management Plan
  • 2.39 Change Management Plan

3.0 Executing Process Group:

  • 3.1 Team Member Status Report
  • 3.2 Change Request
  • 3.3 Change Log
  • 3.4 Decision Log
  • 3.5 Quality Audit
  • 3.6 Team Directory
  • 3.7 Team Operating Agreement
  • 3.8 Team Performance Assessment
  • 3.9 Team Member Performance Assessment
  • 3.10 Issue Log

4.0 Monitoring and Controlling Process Group:

  • 4.1 Clinical Risk project Performance Report
  • 4.2 Variance Analysis
  • 4.3 Earned Value Status
  • 4.4 Risk Audit
  • 4.5 Contractor Status Report
  • 4.6 Formal Acceptance

5.0 Closing Process Group:

  • 5.1 Procurement Audit
  • 5.2 Contract Close-Out
  • 5.3 Clinical Risk project or Phase Close-Out
  • 5.4 Lessons Learned



With this Three Step process you will have all the tools you need for any Clinical Risk project with this in-depth Clinical Risk Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose Clinical Risk projects, initiatives, organizations, businesses and processes using accepted diagnostic standards and practices
  • Implement evidence-based best practice strategies aligned with overall goals
  • Integrate recent advances in Clinical Risk and put Process Design strategies into practice according to best practice guidelines

Defining, designing, creating, and implementing a process to solve a business challenge or meet a business objective is the most valuable role; In EVERY company, organization and department.

Unless you are talking a one-time, single-use project within a business, there should be a process. Whether that process is managed and implemented by humans, AI, or a combination of the two, it needs to be designed by someone with a complex enough perspective to ask the right questions. Someone capable of asking the right questions and step back and say, 'What are we really trying to accomplish here? And is there a different way to look at it?'

This Toolkit empowers people to do just that - whether their title is entrepreneur, manager, consultant, (Vice-)President, CxO etc... - they are the people who rule the future. They are the person who asks the right questions to make Clinical Risk investments work better.

This Clinical Risk All-Inclusive Toolkit enables You to be that person.


Includes lifetime updates

Every self assessment comes with Lifetime Updates and Lifetime Free Updated Books. Lifetime Updates is an industry-first feature which allows you to receive verified self assessment updates, ensuring you always have the most accurate information at your fingertips.