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FDA And EMEA INSPECTIONS OF CLINICAL INVESTIGATORS - page 2 / 5

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Representatives from the Sponsors’ Compliance Department, and the Clinical Research Department, should visit the investigator, at the site of the pending inspection, to;

  • Review the EMEA/FDA inspectional process

  • Provide instruction of inspectional behavior

  • Sequester, review and assess the study documentation required to be maintained

  • Reassure the investigator and staff that the sponsor is available to assist during the inspection

  • Perform a risk assessment of the study site, study data and state of regulatory compliance

The sponsor should inform the investigator that inspections usually last 5 to 8 days, but may be longer dependent on various factors, including the length, size and complexity of the study.

Preparing for the Inspection – Clinical Investigator

To start, a meeting room and access to photocopying equipment should be arranged prior to the inspection. The investigator, or someone closely involved with the study, should review the study records so as to be prepared to produce documentation and/or answer questions regarding the following:

  • Subject Data

    • o

      All source documents, medical records, clinic/hospital records related to the study for all patients, including, study visits, AE reports, lab data, X-rays, etc.

      • o

        Case Report Forms and data queries

      • o

        Patient screening, recruitment and enrollment records

      • o

        Signed informed consent forms for all subjects

  • Regulatory Documents

      • o

        Country specific forms such as

      • o

        FDA 1572

      • o

        Investigator Financial Disclosure forms

      • o

        MOH authorization

      • o

        Local ethics committee favorable opinion

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