Clinical trials audit trails

Most clinical trials have problems, sometimes detected by inspection and audit. These can usually be resolved and, if so, the regulatory submission must include a full explanation of how they were dealt with. Therefore, an audit trail with all the data should be available, accompanied by a statement by QA confirming that the procedures have been audited. 

It is ultimately the sponsor s responsibility to ensure that cGCP is followed in its clinical trials, even though some of the work is contracted out to CROs and other service providers. With regard to analytical laboratories, GCP guidances require that all laboratories have full documentation, data-audit trails, standard procedures, trained staff, archives of samples and data, and routine quality assurance inspections (Prokscha, 2007). If multiple laboratories were to be used, the sponsor would need assurance that GCP requirements were met for every one. In contrast, if a central laboratory is used and all samples are shipped to it, the sponsor only needs to check GCP compliance at that laboratory. 

Integrating ERMS with automated laboratory information systems and clinical and nonclinical trials databases is a critical issue. Records and documents can come from laboratory devices as well as word processing, spreadsheet, database, e-mail, and web-based applications. An ERMS must integrate all of these functions into a cohesive workflow that prevents unauthorized access and logs all activity in an FDA compliant audit trail. 

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