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Safety Data Exchange Agreement Template

This 19-page template can be used as the basis of all safety data exchange agreements with subsidiaries, business partners, licensees, licensors, sub-contractors and agents of the company.

Areas covered in the template SDEA include:

 

  1. The format of the SDEA
  2. Reporting timeframes, notification and responsibilities
  3. Responsibilities for the analysis of safety data
  4. Notification of ongoing and planned clinical trials
  5. Notification of any known safety issues or concerns
  6. The process by which AEs are transferred between the two companies
  7. Metrics in place to monitor the transfers
  8. Reconciliation of AEs transferred
  9. Assessment of expectedness and relatedness (causality)
  10. Lack of efficacy
  11. The frequency and scope of literature searches
  12. Reference documents for determining labeledness (expectedness)
  13. What happens in relation to serious adverse events on comparator drugs
  14. Overdose, misuse, abuse and pregnancy
  15. The number of attempts and the timing of follow-up
  16. Which versions of MedDRA are used
  17. “Events of Interest” which will always be communicated
  18. Responsibilities for reporting to ethics committees/IRBs and investigators
  19. How blinded reports are handled, under what circumstances the blind will be broken, and who is informed (investigators, ethics committees/IRBs, regulatory authorities)