Table 1.

Prestudy documents

Curriculum vitae (CV) - usually required of the PI and all co- or sub-investigators. CVs should be up-to-date, signed and dated to show that they are current. Lab certifications - licenses, certifications and normal laboratory values must be on file*. Signed protocol - This must be signed and dated by the PI. Financial/certification disclosure - Every PI needs to certify/disclose if he/she has a financial interest in the sponsoring company or device being tested*. Institutional review board or ethical committee approval Study budget Letters of agreement with sponsor* Approved informed consent form

^*If applicable, PI: Principal investigator