Published: 17.01.2018 07:42

Compliance program guidance manual for fda staff

«Compliance program guidance manual for fda staff» in pictures.

FDA Compliance Program Guidance Manual for Sponsors & CROs

Regulatory Procedures Manual is a reference manual for FDA personnel. It provides FDA personnel with information on internal procedures to be used in processing domestic and import regulatory and enforcement matters. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.

FDA INSPECTIONS OF CLINICAL INVESTIGATORS

by the Comptroller of the Currency, the Federal Reserve System, and the Consumer Financial Protection Bureau on 66/59/7567

Investigator/Staff Guidance for FDA Inspections | ORRP

Because of their oversight responsibilities, boards of directors have a unique opportunity to influence their health care organizations to promote quality of care and embrace compliance with the law. These resources can help directors, who may not be lawyers or health care providers, create a corporate culture that promotes high-quality care and embraces compliance with the law.

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The Food and Drug Administration (FDA) conducts site inspections of clinical investigators involved in FDA-regulated clinical trials to determine compliance with applicable regulations. The HSO’s FDA Site Inspection Guide provides practical advice for Principal Investigators (PI) and research staff undergoing a FDA inspection. The Guide outlines step-by-step pre-inspection preparations, recommended study team conduct during the inspection, potential post-inspection outcomes, and directions for post-inspection activities. Please refer to the Guide below for details.

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Any suggestions, relevant guidelines or regulations you could provide on the submission of protocol deviations to IRBs would be appreciated.

Please note that FDA's regulations do not define the term protocol deviation. A protocol deviation could be considered a change to the protocol. In general, changes or deviations to the protocol require approval prior to implementation, unless a protocol change is intended to eliminate an apparent immediate hazard to subjects, then it may be implemented immediately provided FDA is subsequently notified and the reviewing IRB is notified in accordance with 76 CFR (c).

The FDA Bad Ad program includes a CME/CE e-learning course and case studies to raise healthcare providers and students' awareness of misleading prescription drug promotion and other common regulatory concerns.

These educational materials assist in teaching physicians about the Federal laws designed to protect Medicare and Medicaid and program beneficiaries from fraud, waste, and abuse. The materials summarize the five most important Federal fraud and abuse laws that apply to physicians and provide tips on how physicians should comply with these laws in their relationships with payers, vendors, and fellow physicians and other providers.