INVESTIGATOR ASSURANCESversion February 2025

INVESTIGATOR ASSURANCES

version February 2025

COMPLETE FORM BY MAKING ATTESTATIONS BELOW, SIGN, DATE AND UPLOAD WITH SUBMISSION REVIEW REQUEST.

Attestations part 1*

1) The information provided is true and correct to the best of my knowledge.

2) I understand as the PI, I have ultimate responsibility for the conduct of the study, the ethical performance of the project, the protection of the rights and welfare of human subjects, and adherence to any stipulations imposed by the IRB.

Attestations part 2*

You must coordinate the use of hospital personnel or facilities that may be required in connection with this research study and confirm that all investigators and research personnel have appropriate clinical privileges to carry out the study.

3) Before commencement of this activity, I will secure arrangements with appropriate Piedmont Administration and Medical Staff Committees.

Attestations part 3*

4) I will not implement the proposal described above or any changes to the protocol until I have received written approval from the Piedmont Healthcare IRB. (Except in an emergency, if necessary, to safeguard the wellbeing of human subjects).

5) Legally effective informed consent will be obtained from human subjects or their legally responsible representative. (when applicable).

Attestations part 4*

6) I will promptly report significant or untoward adverse effects or unanticipated problems to the IRB in writing within 10 working days of occurrence.

Attestations part 5*

7) I will abide by the protocol submitted and will comply with all policies, procedures, and requirements of Piedmont Healthcare and federal regulations.

8) I will maintain sufficient expertise to carry out the functions of the protocol.

Attestations part 6*

Study team members with expired certifications will be immediately dismissed from study participation until such time they are in compliance with the education and training requirements.

9) All study team members will maintain valid required training certifications for the duration of their involvement in the study.

10) Minimally, all study team members will be properly trained to all non-administrative protocol amendments.

PI Signature

__________________________________________________

Date

_________________

Send me a copy of my responses

Privacy Notice|Report Abuse