Study Changes

Sponsors and investigators are responsible for obtaining prospective Board review for changes in research activity. Examples of changes in research that should be submitted to the Board for review and approval include:

  • Amendments and changes to the protocol (including administrative changes such as protocol clarification letters)
  • Change in principal investigator
  • Changes in the primary and/or additional research facilities (location move, suite number change, facility name change, etc.)
  • Addition of research facilities for a previously approved investigator
  • Changes in the investigator’s conflict of interest status
  • Notification of study completion/closure
  • Planned increase in the number of participants to be enrolled in the study
  • Changes in planned enrollment of vulnerable populations, including, but not limited to, employees and family members of employees, illiterates, and non-English speaking participants
  • Intentional departure from the inclusion/exclusion criteria set forth in the protocol when such variation affects the safety or welfare of study participants or affects the study integrity, even if the departure is approved by the sponsor

U.S. amendments can be submitted to one of the daily meetings and must be submitted by 5:00 p.m. PT 36 hours prior. Canadian research must be submitted (with all required elements) to the Wednesday meeting by 5:00 p.m. PT the week prior.

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