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FDA And EMEA INSPECTIONS OF CLINICAL INVESTIGATORS - page 3 / 5

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    Study personnel qualifications, training and experience, including CVs for the clinical investigator and any sub- investigators

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      Evidence of study monitoring by sponsor including

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      Protocol implementation instruction

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      Investigational drug/device handling instructions

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      Regulatory obligations (i.e., retention of study records)

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      Study protocols and amendments

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      Protocol deviations

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      Study-related correspondence with the sponsor

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      Delegation of research responsibilities carried out by sub- investigators and other study personnel

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      IRB name, location and all correspondence and approvals

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      Investigator’s Brochure and amendments

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      SAE reports sent to the IRB and sponsor

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      Drug accountability, handling and storage documentation

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      Document retention requirements for the required length of time

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      Laboratories certification and accreditation documents

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      Laboratory Directors CV

During the Inspection

Upon the inspector’s arrival, the inspectors will present their credentials (such as a business card and the FDA Notice of Inspection - FDA 482). The investigator should request the inspectors credentials if they are not offered.

After arrival, the inspectors will state the purpose and scope of the inspection. And will likely meet with the principal investigator and others as appropriate.

During the inspection, a sponsor representative should be in daily contact with the principal investigator or delegate to determine how the inspection is progressing and provide any needed/requested assistance.

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