eTMF Toolkit

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Downloadable Resources, Instant Access

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


STEP 1: Get your bearings

Start with...

  • The latest quick edition of the eTMF 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 991 new and updated case-based questions, organized into seven core areas of process design, this Self-Assessment will help you identify areas in which eTMF improvements can be made.

Examples; 10 of the 991 standard requirements:

  1. Is there evidence that the facility (or at service level) has a register that details the completed policy, procedure and protocol reviews and a prioritized schedule for future reviews?

  2. Which organization in the clinical trials industry is using new or novel data sources and technologies most effectively to positively influence clinical development, and why?

  3. Is there documented evidence that the facility (or at service level) has a quality improvement plan that details the improvement actions taken, based on the gaps identified?

  4. 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?

  5. How does providers gradual conversion from paper to electronic record-keeping systems change the meaning of privacy and security requirements and expectations?

  6. Are there processes in place which provide assurances that practices (managed and contracted) and other service providers operate effective risk management?

  7. Is there evidence that the facility (or at service level) ensures the workforce is aware of delegated safety and quality roles and responsibilities?

  8. Is a formal interview the best approach Ð is it likely to identify the best people for the role, or would a different method be more appropriate?

  9. Is there evidence that the facility (or at service level) involves clients and carers in decisions about care and confirm consent to treatment?

  10. Is there evidence that the facility (or at service level) has policies, procedures and protocols in place as part of the governance system?


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 eTMF book in PDF containing 991 requirements, which criteria correspond to the criteria in...

Your eTMF 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 eTMF Self-Assessment and Scorecard you will develop a clear picture of which eTMF 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 eTMF 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 eTMF projects with the 62 implementation resources:

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

Examples; 10 of the check box criteria:

  1. Stakeholder Analysis Matrix: How are you predicting what future (work)loads will be?

  2. Procurement Audit: Was the decision on the award process accurate and adequately communicated?

  3. Procurement Audit: Is the chosen supplier part of your organizations database?

  4. Requirements Traceability Matrix: What are the chronologies, contingencies, consequences, criteria?

  5. Project Schedule: How closely did the initial eTMF project Schedule compare with the actual schedule?

  6. Team Operating Agreement: Do you listen for voice tone and word choice to understand the meaning behind words?

  7. Lessons Learned: What were the problems encountered in the eTMF project-functional area relationship, why, and how could they be fixed?

  8. Probability and Impact Matrix: Which of your eTMF projects should be selected when compared with other eTMF projects?

  9. Cost Management Plan: Are the quality tools and methods identified in the Quality Plan appropriate to the eTMF project?

  10. WBS Dictionary: Are procedures in existence that control replanning of unopened work packages, and are corresponding procedures adhered to?

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

1.0 Initiating Process Group:

  • 1.1 eTMF project Charter
  • 1.2 Stakeholder Register
  • 1.3 Stakeholder Analysis Matrix


2.0 Planning Process Group:

  • 2.1 eTMF project Management Plan
  • 2.2 Scope Management Plan
  • 2.3 Requirements Management Plan
  • 2.4 Requirements Documentation
  • 2.5 Requirements Traceability Matrix
  • 2.6 eTMF 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 eTMF 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 eTMF 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 eTMF 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 eTMF project with this in-depth eTMF Toolkit.

In using the Toolkit you will be better able to:

  • Diagnose eTMF 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 eTMF 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 eTMF investments work better.

This eTMF 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.