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FDA And EMEA INSPECTIONS OF CLINICAL INVESTIGATORS - page 5 / 5

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immediately to the sponsor. If there is no observation, this will be stated, but no form/list will be issued. Observations are the inspector’s interpretation that there were deviations from regulations, requirements or the study protocol. It is important that any observations be reviewed carefully during the wrap-up discussion to assure that none of them are due to a misunderstanding. A written response to inspectional observations should be prepared in anticipation of a formal response request by the inspecting agency. The sponsor can review the response before it is sent to the agency.

Recap

In summary, the investigator should be prepared in the event of an FDA inspection to:

Call the sponsor immediately when Review the study documentation

notified

Be prepared to answer questions documents noted above

and

provide

copies

of

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