Change of Principal Investigator
The amendment process for a change in study responsibility from
one investigator to another usually requires the following information
to be submitted to WIRB®.
From the Relinquishing Principal Investigator:
- A letter stating that there will be a change in study responsibility.
The new principal investigator should be named.
From the Study Sponsor:
- A letter or fax from the sponsor indicating acknowledgment and
approval of this change in responsibility.
From the new Principal Investigator:
- A completed WIRB&ref; Research Review Submission Form
- A letter accepting responsibility for the study
- A revised FDA Form 1572 [Statement of Investigator] (if applicable)
- A copy of the new investigator's Curriculum Vitae
- A copy of the new investigator's current medical license
