Researcher Incident Report Form
Directions: All incidents (minor issues, protocol change/deviation, unanticipated problems, or adverse events) must be reported by the principal investigator/project evaluator/researcher directly to HIRB within 10 calendar days from the date of discovery. In addition, for more severe problems or events, the project sponsor or funding agency must also be notified. For more information on incident reporting, the FDA has a guidance document that can be accessed at http://www.fda.gov/downlaods/RegulatoryInformation/Guidances/UCM126572.pdf
Sign in to Google to save your progress. Learn more
Project Investigator Name:
Project Name:
Project Number:
Date of occurrence:
MM
/
DD
/
YYYY
Date Investigator became aware of occurrence:
MM
/
DD
/
YYYY
Address of site where the incident took place:
Next
Clear form
Never submit passwords through Google Forms.
This content is neither created nor endorsed by Google. - Terms of Service - Privacy Policy

Does this form look suspicious? Report

Google Forms