Data audits

Auditing data that have been captured, manipulated, transferred, and reported electronically has produced new challenges for QA personnel. In general, auditing electronically captured data from studies conducted in compliance with GLP should be approached no differently than performing any other data audit however, there are additional considerations. 

In electronic data packages used in held studies, there are some electronic data that are directly entered by the held investigator (FI) and some that are generated by the program (e.g., dates and times). Both types of raw data need to be verified by QA personnel, who should check not only directly entered data, but also computer-entered data. In order to conduct a thorough data audit, QA should determine which data are direct entry and which are automatic. 

QA should ensure that notes and various descriptions (e.g., sampling method, test system observations, etc.) are clear and thorough during the raw data audit. In addition, all audit trails should be checked for clarity and to ensure that each... 

Although the static type model tells what snapshots could be drawn at any one moment, a snapshot may contain plans for the future (schedules and timetables) as well as historical data (audit trails). So a list of past loans would be a valid attribute of a book. 

CRAs achieve these tasks through frequent visits to the clinical trial site. During these visits, the monitor will verify source data, audit regulatory documents for accuracy and completion, perform drug accountability assessments, and communicate any concerns, problems, or new information with the study staff. 

Data audits of IMS Health as reported in PhRMA 2000 Pharmaceutical Industry Profile and subsequent IMS news releases. 

Pinkus KV. Einancial auditing and fraud detection Implications for scientific data audit. Acct Res 1 53-70. 1989. 

Biobatch manufacturing Inspection to determine the establishment s compliance with cGMP requirements, including a data audit of the specific batches on which the application is based (e.g., pivotal clinical, bioavailability, bioequivalence, and stability) is a field office responsibility. CDER scientists are responsible for the review and evaluation of the records and data submitted in the application, including the components, composition, batch instructions, in-process and finished product test points, and... 

The second point is understanding the difference between a GLP audit, a data audit, and a technical audit. It is the industry position that these are three separate entities. All of these are legitimate EPA activities. We realize it s tempting for scientists to delve into the technical details of a particular study when conducting a GLP inspection. However, we believe this is the purview of other EPA activities and the GLP inspector should "stick to the knitting." On the other hand, we realize that one cannot be blind to discrepancies between raw and reported data, and technical... 

If a data audit is performed, the inspectors may request to see the SOPs that were in effect when the study was conducted. 

The conduct of a chemistry-related good laboratory practice (GLP) laboratory inspection and data audit will be discussed in this paper. This will be accomplished fcy describing the basic audit procedure, then digressing into the objectives of an audit and the primary problem areas that have been experienced. 

The laboratory to be inspected will receive a letter approximately two weeks before the Agency inspection team arrives that specifies which studies will be audited and if a laboratory GLP inspection is to be included. Upon arrival, the inspector will present official credentials and a Notice of Inspection form. The GLP portion of the audit is now conducted as if GLPs for all types of studies were in effect. For those laboratories conducting non-GLP studies, this is done to give an idea of what to expect when, and if, the GLP regulations become law. The laboratory inspection aspects will be reviewed briefly and then the data audit portion will be discussed. 

A data audit may be either priority or routine. Priority audits are conducted if a discrepancy, data gap, or other potential violation is suspected. Routine audits of studies submitted for pesticide... 

At the end of the facilities inspection and data audit, the inspector will present the laboratory with a Receipt for Samples form. This form lists all of the copies of documents, samples, etc., the inspection team collected for use in documenting the findings of the audit in their report. The laboratory will be given a closing session in which the auditors and the Inspector will discuss their findings. Frequently, this conference also provides a time for a question and answer session or an exchange of ideas. 

The audit was divided into two parts (1) General QA Practices and (2) Data Audit. A questionnaire as used by EPA s Office of Pesticide Programs, Quality Assurance Office, for Internal Audits, was employed. A copy of the completed questionnaire is(not) attached. From discussions, based on the questionnaire and observations made during inspection of the facilities and from a data audit, a subjective summary regarding... 

E. The laboratory audit and data audit were concerned with only the Pesticide-Toxic Chemicals Section of the laboratory. General comments on these areas of responsibilities follow ... 

In conclusion, the Data Audit was considered to be successful. One study was found to be acceptable and another study showed the need for improved QA practices. Fortunately, GLP s were of sufficient quality that no loss or compromise of data was experienced."... 

Analyses for benomyl residues in Chinese cabbage, data audit, 121-1221... 

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. 

Password Expiry Retention of Data Audit Trails User Profiles Timeouts... 

The FDA has in the past promoted the ability to reprocess electronic records, that is, to retrospectively process necessary raw data again using the same or equivalent conditions to prove the integrity of original records. Such processing requires metadata data about data. Audit trail information is insufficient to reprocess electronic records. Details of the software originally used to create and maintain the records are also required to reprocess records together with hardware platform dependencies. 

Auditing methods can validate data. Audit techniques are commonly used to validate data entries into a metrics system. Such techniques may include reviewing the data and asking some selected questions, such as ... 

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. 

Zhang P. 2004. Statistical issues in clinical trial data audit. Drug Inf. J. 38(4) 371-386. 

It might be added here, that these responsibilities will certainly be transferred to their full extent to an eventual replacement Study Director. Since a permanent replacement will entail the privilege - or the burden, whichever describes the situation better - of accepting, with the signature under the statement of GLP compliance of the final report, the full responsibility for the quality, integrity and reliability of the data and the report, it will be one of the first activities of this person to assure him- or herself, as soon as practicable after taking over the new position, and preferably with the assistance of Quality Assurance personnel, of the GLP compliance in the study as it has been conducted to date. If this were to be done by means of an interim review or data audit, the results of such a GLP review should be fully documented, especially in such cases where deficiencies or deviations were found. 

It is able to make available accurate and complete (data, audit trail, and metadata) copies of records in electronic form for inspection, review, and copying. Records are protected so that they are accurate and readily retrievable throughout the required retention period. 

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