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• Training and auditing for clinical trials

Training and auditing for clinical trials

We provide training to ensure that clinical trials are performed to high ethical and quality standards. We also audit the conduct of clinical trials to ensure they are carried out according to Good Clinical Practice (GCP) guidelines.

All employees involved in designing, conducting and monitoring GSK-sponsored trials are trained in GCP. Training is mandatory and employees must have completed the required training before starting or changing jobs. In 2004 there were 11,239 training activities related to GCP. Each "training activity" represents a successful completion of an e-learning module or instructor-led course related to GCP by one of our employees or complementary workers.

We keep detailed training records which are routinely requested by regulatory authorities when undertaking an inspection to assess the competence of employees undertaking clinical trials.

GSK has an internal audit department (independent of the departments responsible for conducting clinical studies) which conducts audits of GSK systems and processes involved in the conduct of trials, as well as auditing clinical research organisations and investigators performing clinical research on our behalf. In 2004, 176 audits were conducted:

• 102 audits of investigator sites conducting GSK-sponsored trials (representing approximately 5% of investigator sites participating in pivotal clinical trials).
• 17 audits of internal GSK systems and processes used in managing clinical trials/data.
• 26 audits of clinical research organisations carrying out clinical trials on GSK’s behalf.
• 17 audits of GSK Country Medical Departments.
• 14 audits conducted in response to suspected irregularities.

Audit results are reported quarterly to the R&D Risk Management and Compliance Board, and annually to the GSK Audit Committee. Any concerns or issues identified during audits are fully investigated and appropriate action taken.

In 2004 these audits resulted in 144 findings that needed further investigation, and 4 investigators were reported to regulatory agencies.

Inspections of investigators, clinical research organisations, independent ethics committees (IECs)/Institutional Review Boards (IRBs) and sponsors of clinical trails are also carried out by regulatory authorities to ensure the safety of trial participants, the quality of data, and that trials are conducted according to GCP. During 2004 there were 29 such inspections of GSK and investigators used by GSK to conduct clinical studies.

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