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Fda Guidance For Industry Investigator Responsibilities

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  • Anytime new responsibilities are delegated to staff the training to fulfill those responsibilities should be provided and documented.Certificates).

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  • This could help the investigator to anticipate adverse drug reactions or otherproblems in clinical trials.
  • Has issued guidance for institutional review boards IRBs clinical investigators and sponsors.

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  • The Sponsor should implement a system to manage quality throughout all stages of the trial process.

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Inspectors are trained in interviewing techniques and may ask different staff members the same questions to determine if they receive conflicting answers.

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Client Feedback

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  • This guidance is intended to assist sponsors, etc.

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This webinar on FDA GCP inspections provides practical information on how to utilize quality improvement methods to effectively prepare for FDA GCP inspections.

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