Directive 2004/9/EC of the European Parliament and of the CouncilShow full title

Study audits U.K.

Test facility inspections will generally include, inter alia, study audits, which review on-going or completed studies. Specific study audits are also often requested by Regulatory Authorities, and can be conducted independently of test facility inspections. Because of the wide variation in the types of studies which might be audited, only general guidance is appropriate, and inspectors and others taking part in study audits will always need to exercise judgment as to the nature and extent of their examinations. The objective should be to reconstruct the study by comparing the final report with the study plan, relevant SOPs, raw data and other archived material.

In some cases, inspectors may need assistance from other experts in order to conduct an effective study audit, for example, where there is a need to examine tissue sections under the microscope.

When conducting a study audit, the inspector should:

• obtain names, job descriptions and summaries of training and experience for selected personnel engaged in the study(ies) such as the study director and principal scientists,

• check that there is sufficient staff trained in relevant areas for the study(ies) undertaken,

• identify individual items of apparatus or special equipment used in the study and examine the calibration, maintenance and service records for the equipment,

• review the records relating to the stability of the test substances, analyses of test substance and formulations, analyses of feed, etc.,

• attempt to determine, through the interview process if possible, the work assignments of selected individuals participating in the study to ascertain if these individuals had the time to accomplish the tasks specified in the study plan or report,

• obtain copies of all documentation concerning control procedures or forming integral parts of the study, including:

  (i)

  the study plan;

  (ii)

  SOPs in use at the time the study was done;

  (iii)

  logbooks, laboratory notebooks, files, worksheets, print-outs of computer-stored data, etc.; checking of calculations, where appropriate;

  (iv)

  the final report.

In studies in which animals (i.e., rodents and other mammals) are used, the inspectors should follow a certain percentage of individual animals from their arrival at the test facility to autopsy. They should pay particular attention to the records relating to:

• animal body weight, food/water intake, dose formulation and administration, etc.,

• clinical observations and autopsy findings,

• clinical chemistry,

• pathology.