BCG External Auditor

This expenditure is to cover the auditing of the cattle vaccine and companion DIVA test field trails to Good Clinical Practice Veterinary (GCPvet). APHA are currently planning to run field trials to verify experimental data to enable the application for veterinary medicine certification for the use of BCG cattle vaccine and its companion DIVA skin test to enhance current TB controls in GB. To assist in this programme APHA require an independent Auditor that has had previous experience of GCPvet field trails of veterinary medicines for cattle.

The auditor will proactively provide independent external assurance to the sponsor that the study meets the requirements of GCPvet. This will include auditing of the protocol for likely problems and potential non compliances before the field trials begin, compliance by the Contract Research Organisation (CRO) with the protocol, that amendments and deviations from the protocol are appropriately recorded, reported and controlled. The final report from the CRO must be audited by the external auditor. Interim and final reports from the auditor will be expected regarding compliance of the trials to GCPvet.

Additional information:

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