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Training and auditing for clinical trials

We provide training to ensure that clinical trials are performed to high ethical and quality standards. We 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 2005 there were 13,085 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’s internal audit department 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 2005, 170 audits were conducted:

• 106 audits of investigator sites conducting GSK-sponsored trials. This represents approximately 5% of investigator sites participating in pivotal clinical trials (pivotal clinical trials are those trials that provide the primary data on which regulatory approval is based).
• 13 audits of internal GSK systems and processes used in managing clinical trials/data.
• 32 audits of clinical research organisations carrying out clinical trials on GSK’s behalf.
• 9 audits of GSK Medical Departments based in specific countries.
• 10 audits conducted in response to suspected irregularities.

In 2005, these audits resulted in 127 findings that needed further investigation and 3 investigators were reported to regulatory agencies.

Audit results are reported quarterly to the R&D Risk Management & Compliance Board, and annually to the GSK Audit Committee. Any concerns or issues identified during audits are fully investigated and appropriate action taken. This may include retraining or, in severe cases, dismissal for the individuals concerned as well as development of new training programmes or procedures to prevent a reoccurrence. Trial data may also be re-analysed.

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 2005 there were more than 50 such inspections of GSK and investigators used by GSK to conduct clinical studies.

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