FDA BIMO Compliance Compliance Program - Clinical Investigators and Sponsor-Investigators скачать в хорошем качестве

FDA BIMO Compliance Compliance Program - Clinical Investigators and Sponsor-Investigators

#FDA #BIMO Compliance Compliance Program - Clinical Investigators and Sponsor-Investigators 00:00 Intro 01:08 FDA BIMO Compliance Compliance Program - Clinical Investigators and Sponsor-Investigators 03:06 Authorities and Administrational 05:38 Protocol Compliance 09:17 Institutional Review Board 11:03 Subject's Records 17:51 Other Study Records 18:52 Control of Investigational Product 21:56 Records Custody and Retention FDA Guideline - Processes and Practices Applicable to Bioresearch Monitoring Inspections 202406 https://www.fda.gov/media/179027/down... The FDA’s New Office of Inspections and Investigations -- What You Need To Know 112024 https://fda.complianceexpert.com/site... FDA Compliance Program CP-7348.809 IRB 20250404 https://www.fda.gov/media/75909/download FDA Compliance Program CP-7348.810 Sponsors and CROs 20210921 https://www.fda.gov/media/75916/download FDA Compliance Program CP-7348.811 Clinical Investigators 20200722 https://www.fda.gov/media/75927/download