Clinical Study Audit
A study audit will involve a review of the study documents at the sponsor and/or CRO (if requested) and an audit of the study documents, data, procedures and facilities at the investigator site. The audit assesses compliance with GCP standards and applicable regulatory requirements. Findings and recommendations for corrective action are summarised in a comprehensive audit report which can be tailored to the clients requirements. Audit certificates are provided for each study audit.
Before contracting out a study to a CRO, the activities that may be transferred to the CRO, such as clinical research, data management and reporting, must be reviewed to assure they meet the requirements of the sponsor and GCP standards. These audits can be performed pre-contract, to ensure the CRO is able to meet its obligations, or at any time after study initiation to verify that the obligations are being met.
Phase I Unit
This audit involves the review of the systems, procedures, practices and documentation at the Phase I Unit to provide assurance that they comply with international requirements and if necessary contractual obligations.
Clinical Laboratory Audit
This audit will involve a review of the systems, procedures and documentation at a clinical laboratory to provide assurance that they comply to international requirements and contractual agreements (if applicable). The timely and accurate reporting of results is assessed along with the communication between the sponsor, investigator and laboratory. This audit can be performed pre-contract, during the contract or on a routine basis.
This audit is conducted to verify that the data transfer from the CRF (or electronic file) to the database is performed such that the locked database complies with acceptable non-conformity rates and it is of a standard suitable for statistical analysis and reporting.
The audit involves comparing a sample of the data contained in the database with the CRFs and query forms (or electronic files). Non-conformities from the comparison are noted and a non-conformity rate for the database produced. Depending on the acceptable non-conformity rate specified, the database is considered to have passed or failed the audit. The follow-up phase upon completion of the audit is important especially if the database fails and contingency planning needs consideration.
Clinical Study Report Audit
Clinical Study Reports are audited to provide assurance that they are produced in accordance with the protocol, statistical analysis plan, sponsor SOPs and regulatory requirements.
The audit verifies that the data collected during the study is completely, accurately and consistently reported in the text, tables, figures and data listings. The Clinical Study Report should reflect the actual conduct of the study and it should possess clarity.
On-the-job training of client auditors can be offered in the use of VERITUS Consulting checklists and auditing procedures or the client procedures if this is requested. Audit reports can be drafted in conjunction with the client auditor to allow them practical experience of the complete audit process.
This on-the-job training allows the training of auditors and the conduct of client audits to be performed simultaneously.
Key systems utilised during the clinical research process are audited to identify areas of non-compliance, inefficiency and inadequate quality in processes relevant to all clinical trials. Such audits also aid in the continuing development of a quality system.
Systems audits can determine what changes will enhance the organisation procedures and they can provide improvements which affect all clinical trials. They can have a greater influence on management and they generate a team approach to systems improvement.