EU clinical practice inspectors highlight document handling errors


More than 650 deficiencies were highlighted for inspections conducted in 2014

Poor performance in the management and preparation of documents was the most common problem highlighted by European Union (EU) good clinical practice (GCP) inspectors in 57 investigations launched in 2014.

An annual report of the EU good clinical practice inspectors working group noted that there were 119 problems discovered involving essential documents, of which 42 were major and four were critical. This included a lack of essential documents, such as receipts for investigational medicinal product shipments; records of blood samples and shipments to central laboratories; incomplete documentation, such as screening lists; and a lack of contemporaneous independent copies case report forms filed on site.

There were also 57 separate difficulties noted regarding source documentation, of which 21 were major. Here the problems included discrepancies between source data and data reported in clinical study reports; missing source documents; and a lack of documents specifying location source data.

And 49 data management issues were identified (28 major problems and four critical). These included inappropriate systems for reporting protocol violations; laboratory reports being submitted late; data management being undertaken after a clinical trial finished; and failures to communicate decisions of the data monitoring safety board.

Most inspections were carried out in the European Union EU) plus Switzerland, Norway, Iceland and Liechtenstein (33.3%), followed by the US (21.1%) and the Middle East/Asia/Pacific regions (19.3%).

Of these, there were 13 non-routine probes – five in Europe, five in the US, two in the Commonwealth of Independent States (CIS), and one in Australasia.

A total of 673 deficiencies, comprising 30 critical (4.46%), 290 major (43.09%) and 353 minor (52.45%) events were recorded for these 57 inspections conducted in 2014.

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Other problems highlighted included poor standard operating procedures (22 major and one critical case); staff training and qualification weaknesses (12 major problems); organisational and personnel errors such as unauthorised tasks (seven major issues).