Sunday, November 1, 2009

Data Management CRO/Sponsor Pharma Roles

The role of the data management CRO chosen by the sponsor pharma to conduct clinical studies at designated and approved sites, domestic and international, and leading to an integrated clinical submission, CTD, eCTD, Clinical Phases 1,2,3, are as follows:

  • Tracks receipt of all data
  • Enters data into the database (at the clinical study level)
  • Performs data review through execution of programmed edit checks as well as through a manual review of the data
  • Maintains an audit trail of all database changes
  • Provides adverse event and concomitant medication coding listings for review
  • Maintains documentation of the resolution of all discrepancies, including those that did not result in a DCF
  • Manages the receipt, loading and processing of any external electronic data received for the clinical study.
  1. Interview the CRO.
  2. Investigate where the CRO conducts studies, North America, South America, Europe, other.
  3. Investigate the experience of the CRO, what indications, which therapeutic areas, safety, efficacy, BE/BA, Clinical Phases 1,2,3, oncology, neuroscience, respiratory, drug, device, biologic, other.
  4. Examine the correspondence and communication tactic of the CRO with FDA.
  5. How well recognized and respected is the CRO in the eyes of FDA?
  6. Ask for a "track record" of approvals, RTFs, filings, Clinical Submissions, eCTD, CTDs globally.
  7. Look at the credibility and experience, resumes and CVs of the CRO staff.
  8. Ask for the resource and capacity available for your clinical studies - some CROs are "over-booked".
  9. Ask for the client list of the CRO.
  10. "Interview the CRO" before making a decision.
  11. Once the CRO is chosen, develop quality management plans to monitor the CRO, contract, conduct, performance, data, etc.
  12. "Monitor the Monitors".
  13. The ultimate responsibility of a credible clinical study and a database with data integrity and accuracy is the sponsor pharma.
  14. Perform Quality Control and Audits periodically during the course of the clinical study.
  15. Start early, after several patients are eligible and enrolled in the clinical study, quality check the data and documentation and paper trail at randomly selected sites.
  16. Use Quality Data Management and Quality Control SOPs and WIs for checking selected clinical study sites.
  17. Monitor the Monitors!

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