Good Clinical Data Management Practice Toolkit

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Save time, empower your teams and effectively upgrade your processes with access to this practical Good Clinical Data Management Practice Toolkit and guide. Address common challenges with best-practice templates, step-by-step work plans and maturity diagnostics for any Good Clinical Data Management Practice 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 Good Clinical Data Management Practice specific requirements:


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the Good Clinical Data Management Practice 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 833 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which Good Clinical Data Management Practice improvements can be made.

Examples; 10 of the 833 standard requirements:

  1. Is your organization helping providers share health information with each other through a health information exchange, clinical data repository, case management tool or some other means?

  2. Are mechanisms in place to capture the necessary data to inform quality service provision, competent case management and feed into the overall cycle of commissioning?

  3. Is data acquisition to inform on the planned adaptations rapid enough community the required analyses to inform the adaptation can be completed in time?

  4. What are the main information related problems you have identified in the decision making process supporting clinical service management in your area?

  5. Do you support quality process and outcome measures based on clinical data, including from clinical records, registries and other sources?

  6. Are there any other requirements of which you should be aware in addition to the skills competency and professional values requirement?

  7. How is identification of risks and benefits implemented within GCP and where may information about risks and benefits be obtained?

  8. Is there a way to know how each shift/unit/department is doing in a clinical area, or is there only facility level data available?

  9. Should you in Clinical Data Management strive to develop a similar standard number that might instantly enhance your status?

  10. Are you in clinical data management using data analytics as effectively as your peers in marketing or commercial operations?


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 Good Clinical Data Management Practice book in PDF containing 833 requirements, which criteria correspond to the criteria in...

Your Good Clinical Data Management Practice 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 Good Clinical Data Management Practice Self-Assessment and Scorecard you will develop a clear picture of which Good Clinical Data Management Practice 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 Good Clinical Data Management Practice 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 Good Clinical Data Management Practice projects with the 62 implementation resources:

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

Examples; 10 of the check box criteria:

  1. Planning Process Group: Is the Good Clinical Data Management Practice project making progress in helping to achieve the set results?

  2. Procurement Audit: If the expert was allowed to submit a tender, was all the relevant information the expert had gained from his earlier involvement made available to the other bidders?

  3. Procurement Audit: Are there appropriate controls in place to ensure that procurement complies with the relevant legislation?

  4. Probability and Impact Assessment: What are the industrial relations prevailing in your organization?

  5. Variance Analysis: Are work packages assigned to performing organizations?

  6. Schedule Management Plan: Are the Good Clinical Data Management Practice project team members located locally to the users/stakeholders?

  7. Procurement Audit: Are staff members evaluated in accordance with the terms of existing negotiated agreements?

  8. Probability and Impact Matrix: Were there any Good Clinical Data Management Practice projects similar to this one in existence?

  9. WBS Dictionary: Does the contractors system include procedures for measuring performance of the lowest level organization responsible for the control account?

  10. Schedule Management Plan: Does the time Good Clinical Data Management Practice projection include an amount for contingencies (time reserves)?

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

1.0 Initiating Process Group:

  • 1.1 Good Clinical Data Management Practice project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 Good Clinical Data Management Practice project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 Good Clinical Data Management Practice 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 Good Clinical Data Management Practice 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 Good Clinical Data Management Practice 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 Good Clinical Data Management Practice project or Phase Close-Out
  • 5.4 Lessons Learned

 

Results

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

In using the Toolkit you will be better able to:

  • Diagnose Good Clinical Data Management Practice 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 Good Clinical Data Management Practice 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 Good Clinical Data Management Practice investments work better.

This Good Clinical Data Management Practice 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.