Serious Breaches Training

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Across
  1. 1. Legally responsible for notification of a Serious Breach
  2. 4. System used to capture IDP information
  3. 5. Number of days in which a Sponsor has to report
  4. 6. The degree to which a serious breach is likely to effect the scientific value of the trial
  5. 8. Nature of the SB information
  6. 11. The contact reporting the SB
  7. 12. Manager Reviews the IPD in the CTMS system
Down
  1. 2. A possible Serious breach
  2. 3. When in doubt, you should do this
  3. 7. Likely outcome for not reporting an SB
  4. 9. Method by which the MHRA should be notified
  5. 10. Name of the regulatory body that should be reported to