Reporting Responsibilities
Salus IRB requires the investigator to report certain information during the course of the study. Changes in research require IRB approval prior to implementation except when necessary to eliminate an apparent immediate hazard to research participants.
For investigators participating in multi-site research in which Salus IRB is the central IRB, unless the sponsor has agreed in writing to submit the study-wide changes on your behalf, you are required to submit these to the IRB:
- Revisions/amendments or administrative/clarification letters to the protocol
- Revisions to the investigator’s brochure/study product information
- Planned protocol deviations
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