Safety Data Exchange Agreement Template

SJ Pharma Consulting, LLC in Mendham, NJ developed a 19-page template that may be used as the basis of all safety data exchange agreements (SDEAs). The template is for the agreements between the company and its subsidiaries, business partners, licensees, licensors, subcontractors, and agents.
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The SDEA template covers the following areas
 
  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 are informed (investigators, ethics committees/IRBs, and regulatory authorities)