Study reports audits

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. 

The records required for field residue study authentication are the same records that would be required to reconstruct the study. Although this total volume of information is a necessary part of the GLP study record, the field summary report is a small fraction of that record. The field summary report is simply the information the EPA reviewers wish to see as they consider the data and determine how well they represent the crop situation for which the pesticide tolerance is being requested. At the current time, the field summary report should contain the information requested on pp. 48 and 49 of OPPTS 860.1500. The summary report for each test site in a study will typically form an appendix in the final study report. This information must be accurately extracted from the raw data notebook or field record and must be audited by... 

The integration of different forms of study information from various locations and sources is possible with electronic information. Both study management and quality assurance are addressing critical issues associated with this process. Study Directors must now keep track of more data and study reports than ever before. Quality assurance (QA) departments must have systems in place to audit electronic data. 

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 new GCP requires that sponsors shall compile plan and operating procedures on auditing and implement auditing in conformity with the plan and the procedures, thus auditors audit not only the sponsor s in-house process but also processes at study sites. Within the sponsoring company, usually aU CRFs and study reports are subject to the audit. Study sites are selected for audit based on auditors SOP, usually based on sampling methodology. Audit certificate for each clinical trial is required to be incorporated into new drug submission dossier. 

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-... 

Inspections and Final Report Audits for Environmental Studies... 

Accuracy of the final study report—The role of CQA is essential at this phase of trial activity. The final study report must be audited for accuracy and consistency against a broad body of data. If a study is terminated early or extended beyond the protocol period, the final report must reflect all the safeguards employed to ensure both patient safety and data integrity. 

If original subject records were audited or reviewed by the sponsor in the course of monitoring any clinical study to verify the accuracy of the case reports submitted to the sponsor, a list identifying each clinical study so audited or reviewed. 

Equipment maintenance and calibration records GLP protocols and amendments QA audit records Standard Operating Procedures Final Study Reports and QA Statements Training records Job descriptions... 

Before 1990, clinical trials conducted in Russia were characterized by a number of peculiarities. Many trials had no protocol and were carried out following the recommendations of the MOH. No ethics committees existed. There was no communication between the sponsor and the investigator, and the latter had no idea about the monitoring or audits, as if no such things existed. Moreover, the clinical data (study reports) would go directly to the Pharmacological Committee without being circulated to the sponsor. 

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. 

Systems audits in this late phase in clinical trials aim at assessing related procedures to ensure that capable procedures exist for managing and cleaning clinical trial data, for conducting statistical analyses and for preparing the final study report which represents properly the data collected and reported in the clinical trial. Such systems audits are performed across functional boundaries. Such systems audit can be combined with a database audit and/or an audit of the final study report. 

The monitoring report and audit report should be made available before release of the final study report. 

Quality assurance of the BE study audits of clinical and bioanalytical part of the study and the study report... 

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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