Managing a Monitoring Plan

The following guidelines are provided to assist with managing your approved monitoring plan.

Investigator Responsibilities

Principal Investigators are required to:

a. Submit their Monitoring Plan Renewal Form 30 days prior to their renewal date.

b. Promptly report any changes to their monitoring plan at ori@fiu.edu.

c. Continuously submit the Exhibit B. Employee Disclosure Statement to ori@fiu.edu as new students/employees are hired.

d. Adhere to high ethical standards.

e. Comply with the requirements in the approved Monitoring Plan.

Submitting Renewals

a. The employee must email the completed Monitoring Plan Renewal Form to ori@fiu.edu 30 days prior to the renewal date. ORI will ensure that all required information is provided.  If the information is not complete, it shall be returned to the employee for completion.

b. Once the required form is complete, ORI shall assign it to the Conflict of Interest Research Committee (COI-RC) for review and recommendation to the Designated Official.

c. ORI will issue a memorandum to the employee and appropriate FIU units regarding whether the monitoring plan has been renewed as is, renewed with revisions or terminated.

Submitting Amendments

a. The employee must email the completed Monitoring Plan Amendment Form to ori@fiu.edu. ORI will ensure that all required information is provided.  If the information is not complete, it shall be returned to the employee for completion.

b. Once the required form is complete, ORI shall assign it to the Conflict of Interest Research Committee (COI-RC) for review and recommendation to the Designated Official.