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Real-Life Example

Preparation of a Trial Site for an Inspection

A pharmaceutical company mandated Pharmatio with the preparation of a study site participating in a clinical study for an inspection, which was announced on short notice.

The pharmaceutical company needed professional support. The Clinical Research Associate (CRA) from the Clinical Research Organization (CRO) commissioned with monitoring the trial site, was still very unexperienced in preparing inspections. According to the clinical monitor the documentation at the trial site, despite his efforts, also left much to be desired,

Pharmatio was able to provide the company with a monitor experienced in the preparation and accompaniment of audits and inspections for this task in the short run.

In the beginning, our colleague was informed about the therapeutic area and the indication of the clinical trial, the patient visits to be performed and all the specifics of the study to be considered during the documentation and data capture at the trial site as well as about the structure and content of the investigator site file.

Equipped with the essential documents for the investigator site file and all the monitoring reports compiled so far, our colleague then went to the trial site, where she met the CRA of the contract research organisation. After a short introductory interview with the study team, our colleague had the CRA introduce her to the documentation and data capture of the patient visits and problematic documentation in the patient files from the CRA's point of view.

The documentation at the trial sites was completely reviewed in just three days and prepared for the inspector's visit. Once again the investigator and his study nurse were trained by the CRA of the contract research organisation in the essential problem areas, namely the correct and complete documentation in the medical records, the management of the drug accountability and temperature logs, the maintenance of the essential documents in the investigator site files, as well as their role during the inspection and a professional communication with the inspector.

Then came the day of the inspection, where the sponsor’s local project manager, our colleague, the CRA of the contract research organisation, the investigator and the study nurse from the site were present, besides the inspector of the BfArM. The inspection was completed with only three Minor Findings in the documentation of the 256 study patients.