3 Mission of a Sponsor’s Auditing Department
A quality management system is established to define quality policy and implement quality management. Quality Control (QC) and Quality Assurance (QA) are implemented in accordance with the quality policy. As part of implementing Quality Assurance, a sponsor’s audit is generally performed to accomplish the following missions:
1. To evaluate compliance with the reference documents so as to ensure the reliability of trial data and protection of the subject’s rights.
2. To evaluate the effectiveness of the clinical trial system and provide an opportunity for the sponsor to improve it.
It is expected that the results of an audit will be utilized by the auditee as essential information for the improvement of the clinical trial system or by the sponsor’s chief executives as material for making a business judgment about the quality of clinical trials. To accomplish the above objectives, the sponsor is expected to establish an independent auditing department and to ensure that the auditor(s) is(are) appropriately qualified by education and training.
4 Auditing Department
It is useful for the sponsor to establish an independent auditing department so as to ensure systematic and continuous conduct of audits. To ensure that a sponsor’s auditing department functions effectively the sponsor should fulfil the conditions specified in paragraphs 4.1 to 4.4 below, specify the roles and responsibilities of the auditing department, and establish written SOPs for the performance of audits. It is possible for a sponsor to define the responsibilities of a department manager and assign the manager if necessary.
4.1 Independent Auditing Department
The auditing department should be independent of the auditees so as to ensure the credibility of its audits. Auditing is part of Quality Assurance and involves independent and objective evaluation of clinical trials. The auditing department fulfils part of the Quality Assurance responsibilities of the sponsor.
4.2 Qualified Auditors
The sponsor should establish an auditing department with qualified auditors so as to ensure the proper conduct of audits as part of implementing Quality Assurance. Each auditor’s qualification should be documented to verify that he/she is a suitable person to properly conduct audits, e.g., records of education/training and business experience.
4.3 Qualifications of Auditors
The sponsor should specify the qualifications of auditors in auditing procedures and should only appoint appropriate individual(s) as auditor(s) based on consideration of his/her education/training, business experience, and ability. For example:
Knowledge: Necessary laws and regulations, GCP, relevant guidelines, the Declaration of Helsinki, clinical and pharmaceutical knowledge, SOPs, computerized system validation, etc. Skills: Communication, writing, language, etc.
Nature: Tenacity, power of observation analytical capability, decision, sense of ethics, maturity, etc.
4.4 Responsibilities of Auditors
The sponsor should specify the roles and responsibilities of the auditor before starting to conduct an audit so as to ensure fair and smooth performance of the audit. The auditor is responsible for maintaining the confidentiality of information obtained during an audit, planning (designing and updating) and conducting the audit, and reporting the audit results.