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CVIA Common Structure Test/lkj/.kmn
- Functional Documents
  - {Project Short Name} Clinical
    - Clinical Agreements
      - {Study Number}
        Central Trial Level Documents
        File Notes, Meetings and Correspondence
        Clinical Study Reports
        Template Subject Materials
        Trial Documents
        Local Laboratory Testing
        Facility Documentation
        File Notes, Meetings and Correspondence
        Sample Documentation
        Data Management
        Data Capture
        Data Management
        Database
        EDC Management Specifics
        Notes, Meetings and Correspondence
        Investigational Product and Trial Supplies
        Notes, Meetings and Correspondence
        IP Allocation Documentation
        IP Documentation
        IP Release Process Documentation
        Storage
        {Name of IRB} IRB
        Correspondence not related to submission
        Initial and Change Research Submission and Approvals
        Other Submissions and Acknowledgements: safety, progress reports, trial termination
  - {Project Short Name} CMC
    - Initial Early Development Reports
      - Initial Early Process Development
        Intellectual Property Evaluations
        Initial Analytical Reports
      - CMC Vendors and Partners
        Target Vendor Profiles
        {Vendor/Partner Name}
        CMO RFPs
        CMO Assessment
        CMO Agreements & SOW
        CMO Capacity
        CMO Audits
        Technology Transfer
        Historical information
        Tech Transfer Plan
        Tech Transfer Execution
        Quality Systems

CVIA Common Structure Test 47 concepts

By @mayimbe