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Training and auditing

Corporate Responsibility Report 2008

Training and auditing

Training for clinical trials

All employees involved in designing, conducting, recording and reporting GSK-sponsored clinical research studies are trained in the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonisation (ICH). Employees must have completed the required training before undertaking these roles.

We keep detailed training records which are routinely requested by regulatory authorities when undertaking an inspection of GSK clinical research trials.

Auditing for clinical trials

GSK’s internal audit department audits the conduct of clinical trials. Audits cover GSK systems and processes, as well as external clinical research organisations and investigators performing clinical research on our behalf.

Trials are selected for audit based on risk. Risk factors include the complexity of the study, the patient population, the location of the study, previous audit history and any unusual findings during the conduct of the study.

Results are reported quarterly to the R&D Compliance Board, and annually to the Risk Oversight and Compliance Council and the Audit Committee of GSK’s Board of Directors. Read more about these in the corporate governance section of our Annual Report. Members of our Global Safety Board (GSB) receive individual audit reports on any safety-related findings.

Any concerns or issues identified are fully investigated and appropriate corrective action taken. For GSK staff corrective actions may include development of new training programmes or retraining for the individuals concerned. In more severe cases appropriate disciplinary action will be taken, up to and including dismissal.

For external investigators, GSK may retrain the investigator, or stop working with the investigator. Trial data from noncompliant investigative sites is excluded from the analysis.

Regulatory authorities also carry out inspections of GSK and the investigators we use to conduct clinical trials.