Audit Reporting

The types of records needed to demonstrate adherence to requirements and standards as well as effective operation of the quality (ESH/PSM) management system are covered in this element. In addition to many of the quality records listed (e.g., inspection reports, audit reports, operational procedures, and drawings), ESH/PSM requirements might include training records, permits, hazard analyses, audit and other response plans, and accident/inci-dent investigation reports. 

QA must review the final study report to make sure that the report accurately describes the methods and SOPs, and that the report accurately reflects the raw data generated during the study. QA personnel need direct access to the on-line data to adequately perform a data/report audit. Access for QA personnel must be in the form of read-only access. 

The responsibility of the QA unit should not be limited to in-process inspections and data and report audits. To be in full compliance with GLP, the QA unit should review all procedures for storing and archiving electronic as well as paper raw data. This review should include ensuring that back up and archiving procedures were performed as specified in the SOPs, that archiving was documented properly, and that long-term storage procedures were followed. 

The QA SOP manual should describe QAU audit and inspection techniques with attached inspection checkhsts, if used. Statistically based methods for random selection of phases of studies for inspection and for random selection of data points during final report audits should be described and justified. Any designation of study phases as critical or noncritical used to estabhsh the frequency of study inspec-... 

GO Allen, AF Hirsch, H Leidy. Application of military STD 105D sampling plans to research report audits to meet GLP requirements. Drug Info J 14 65, 1980. 

Inspections and Final Report Audits for Environmental Studies... 

Methods of sample handling are well documented and assure a good trail-of-evidence from time of sample receipt at the laboratory to time of the report audit. However, information received from the field for individual samples is often incomplete. 

Environmental Protection Agency. EPA s program to control exports of hazardous waste, March 31. Report Audit. EID 37.05-0456-80855 1988. 

Requirements for data presentation, records, and reporting Audit trail requirements and copying of records Communication with external devices Networking requirements Performance requirements Availability Security Maintenance Documentation... 

This function, as has already been stated, is an independent review. The responsibilities here start with a review of the study plan and continue through the review of the study in the in-life phase, data audits, and the final study report audit. 

It may be useful to remind the recipients of the confidential nature of audit reports which means that they should not be made publicly available or distributed to persons outside the company. Regulatory authorities should not routinely be provided with audit reports. Audit reports should be securely filed (ideally with the QA department) and not included in the Trial Master File (TMF). 

The study report is the essence of the clinical trial and summarizes trial data and their interpretation. Since trial reports are part of the package submitted to regulatory authorities for obtaining marketing authorization, the contents must be valid, complete and accurate. Trial report audits verify that all necessary components and attachments are included in the report. Ideally, the last draft version is subject to audit, thus avoiding rework which may be necessary after audits of early drafts which are substantially changed until they are considered final. In addition, all QC checks and activities should have been completed prior to the audit. 

In contrast to GLP regulations, GCP does not require an audit for all trial reports. The number of report audits may depend on the audit plan, the importance of the trial for a regulatory submission and the confidence in the procedures followed for evaluating clinical study data and writing reports, just to name a few. 

An organization of validation reports, audit results, and other documentation should be completed around the systems list, allowing rapid reference for those systems selected. This organizational structure will often identify any documentary gaps, allowing correction prior to the regulatory visit. 

INTRODUCTION OPERATIONAL ISSUES A. Introduction Protocols Documentation Schedules Stability Reports Audits and Inspections... 

Therefore, for any given single study, it would be sufficient to address these issues in process-based inspections, and the requirement that each study should be inspected at least once could be fulfilled by the - in any case performed and also for short-term studies necessary - final report audit. Whether it is thus indeed the well-understood intention of GLP that each and every study, however short its duration, and however repetitive and routine its nature, would have to be inspected at least once in order to achieve full compliance, should, with regard to the wordings in the OECD Principles and the respective Consensus Document, not be a topic for debate anymore. 

Report Audit This report has been audited by the Quality Assurance Department. This audit was conducted and reported to the Study Director and Company Management as indicated above. 

Study plan midit t udy-based inspections / report audit... 

There are a number of issues to be addressed in a final report audit which in their entirety would then serve to determine whether the study had indeed been conducted in compliance with the Principles of GLP. Thus, the Quality Assurance inspector performing such an audit should try to determine whether the study was carried out in accordance with the study plan and the applicable SOPs, whether the study has been accurately and completely reported, and finally whether the raw data are complete and have been recorded and compiled in compliance with GLP. There are some points to be addressed which are more of an administrative nature, like the determination of whether the report contains all the elements required by GLP. One important aspect of the report audit will also be the question of whether the report is internally consistent, although this question may be seen to relate more to the scientific side than to the purely GLP aspects of the report on the other hand. 

At the beginning of section 4.3 the work of Quality Assurance has been likened to the conduct of a study. This likeness may be seen to continue in the recording of the procedures and the progress of a final report audit. Quality Assurance may find it helpful for the resolution of questions and queries that... 

One might possibly be tempted to interpret the economy issue in Quality Assurance resource utilisation also in an additional way, namely that Quality Assurance could perform report audits for short-term studies in just a random fashion, analogous to the inspectional practice. This possibility, however, is precluded by the GLP Principles. They require that Quality Assurance inspect the final reports to confirm that the methods, procedures, and observations are accurately and completely described, and that the reported results accurately... 

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