Clinical Data Management Solutions

Providing Safety and Clinical Data
Management Solutions

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Listing of SOPs and SWPs

IT SOP's

  1. Backup
  2. Change Control
  3. Disaster Recovery
  4. Hardware Maintenance
  5. Software Maintenance
  6. Records Maintenance
  7. Hardware Maintenance
  8. Physical Security
  9. Logical Security
  10. Problem Reporting
  11. Training
  12. Validation and Re-evaluation

    Data Management SOP's

  13. Quality Assurance of Study Reports
  14. Query Generation and Resolution
  15. CRF Development
  16. Database Design
  17. Quality Control of Data Listings
  18. Database Lock and Review Request
  19. Creation of Data Listings
  20. Data Entry and Verification
  21. CRF Receipt and Tracking
  22. Coding of Adverse Events and Medications
  23. Programming Development & Standards
  24. Training Procedures
  25. Electronic Data Transfers
  26. Data Management Plan
  27. Data Management of CROs
  28. Records Management
  29. Scientific Misconduct and Noncompliance

SWP's

  1. Installation
  2. Administration
  3. Backup
  4. Support

     

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