2.2 As Investigator, conduct study according to signed investigator statement, protocol, and applicable regulations: (812 Review guidelines applicable to study: Subpart E) Disclose accurate financial information to the sponsor to Violation/deviation complete certification of financial disclosure statements. Obtain informed consent in accordance with provisions in 21 Adverse reporting requirements CFR 50. IRB FDA Protect rights, safety, and welfare of subjects; Report violations/deviations to IRB; Informed consent Control devices under investigation; Recruitment Supervise device use Submit progress reports to the sponsor at regular intervals (812.150(a)(3)) 3.0 Monitoring
2.2 As Investigator, conduct study according to signed investigator statement, protocol, and applicable regulations: (812 Subpart E) Disclose accurate financial information to the sponsor to complete certification of financial disclosure statements. Obtain informed consent in accordance with provisions in 21 CFR 50. Protect rights, safety, and welfare of subjects; Report violations/deviations to IRB; Control devices under investigation; Supervise device use Submit progress reports to the sponsor at regular intervals (812.150(a)(3)) Review guidelines applicable to study: Violation/deviation Adverse reporting requirements IRB FDA Informed consent Recruitment 3.0 Monitoring
SIR_IDE_training-checklist.docx