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FDA And EMEA INSPECTIONS OF CLINICAL INVESTIGATORS - page 4 / 5

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Regulatory inspectors are trained in investigative techniques designed to detect and confirm misconduct. At times their questions may seem aggressive, repetitive and/or unrelated to the study. This is not necessarily a reflection of significant concern and the best response is to remain calm and not react in kind.

It is best if someone familiar with the study and the patient records is with the inspector at all times or checks in with the inspector’s progress at frequent intervals to answer any questions and determine if additional documents are required or copies needed. Notes should be taken of questions asked and answers given. It is important that someone (preferably the principal investigator) talk with the inspector at the end of each day to determine the progress of the inspection and whether there are any outstanding questions or concerns.

Study-related documents are to be provided to the inspector as requested. If other information is requested which is considered unrelated to the inspection, inform the inspector that the request will be considered and then contact the sponsor as soon as possible. The following are some general rules to consider in responding to an inspector’s questions:

  • Be pleasant, cooperative, calm and completely honest

  • Understand all questions before answering; if there is any doubt, ask to have it repeated, or restate it in your own words

  • Take your time; if you don’t know or are uncertain of the answer, just say so – never guess or speculate

  • Answer questions directly and as briefly as possible without being evasive

Copies of numerous study-related documents, including patient records, will be requested during the inspection, even if no problems are found. Duplicate copies should be made and a set retained for the sponsor as an aid in answering questions, performing risk assessments and, in the event that the inspectors misplace copied documents, to replace misfiled copies.

Post Inspection

A “wrap-up” discussion will conclude the inspection during which the inspector(s) may issue a list of observation/citations (FDA 483 or EMEA list of observations). The observations should be faxed

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