Investigative site audits

Investigator site audits are probably the most frequent type of audits conducted by clinical QA departments and, therefore, deserve particular attention. The purpose of investigator site audits is to assess compliance with the GCP regulations (with a focus on the country-specific regulatory requirements) and the protocol. Further, thesafety of the trial participants, the ethical conduct of the trial and the validity, completeness and accuracy of the data collected and recorded are verified during the audit. 

The investigator site audit concludes with a closing meeting with the investigator and key site personnel to review key audit findings and to suggest corrective and preventive action, if required. 

In a similar manner, QA departments and consultants paid for by the sponsor will conduct audits of investigator sites. Again, as with the clinical trial monitor, there may be some annoyance among the investigator and his staff that some person, who may not be a physician, should be appointed by the sponsor to review the clinical trial documentation at the site. 

Audit skills—A CQA professional should be quite skilled in the area of auditing and capable of evaluating everything from documentation within the CRO, sponsor, and investigator sites. 

Irrespective of whether audits are initiated by the IRB, a sponsor, or the FDA, a number of commonly identified deficiencies have been noted and are addressed below. It is important to note that investigational sites, sponsors, and IRBs are all subject to FDA-issued warning letters or repeat inspections to verify that deficiencies have been adequately corrected. 

Trial-related audits focus on a particular trial to assess compliance with the protocol, with related SOPs and applicable GCP regulations. Of particular interest is how trial participants are informed of the trial, the study activities conducted at the investigator sites and the procedures of clinical data handling, recording, processing, analysis and reporting. 

Preparing for the site audit requires the review of key trial documents before visiting the site for the on-site part of the audit. The QA auditor should review at least the trial protocol (and amendments), the current investigator s brochure (to the extent necessary). Ideally, the following documents should be studied as well before the audit any site-related documents including the IEC submission and approval, approved informed consent form used at the site, monitoring reports for the... 

Systems audits in pharmacovigilance are useful to evaluate all processes and SOPs related to pharmacovigilance and to assess the interaction with investigator sites, CRAs and related in-house personnel involved in handling safety information. QA auditors verify if the pathways and timeframes for reporting AEs and SAEs are followed and that all required recipients of such safety information are notified as needed (e.g. http //eudravigilance. emea.eu.int). SOPs and, if required, protocol-specific... 

Bioresearch Monitoring (BIMO) Audit of several investigational sites Substantive Review Coordination and Completion in Areas such as... 

The quality assurance department within a company will frequently conduct audits of investigator sites, either during a clinical study or after it has been completed. Companies that do not have a quality assurance department or unit may contract this service from a consultant or a third party specializing in regulatory audits. The intent and scope of these audits are the same as the FDA, but they afford a company an opportunity to verify compliance and to correct deficiencies that might otherwise delay product approval. These audits... 

This optional attachment is used to promote continuous improvement of the entire safety management system. It is a checklist for anyone to use as a guide when auditing incident investigation activity. The facility from which this example was derived includes a similar checklist for each safe work practice at the site. 

Provision for monitoring and audit of study site and ongoing cooperation and liaison between sponsor, monitor and CRO/ investigator must be made. 

In preparing for a routine inspection, it is necessary to select toxicology studies for audit that are as representative as possible of the laboratory s current operations. This is done either by the assigning center s GLP unit prior to the inspection or by the field investigator at the laboratory site. When made by the field investigator, the selection is drawn from the firm s GLP master schedule sheet. 

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