Q&A aims to address the situation in which a sponsor uses a system (as intended) by a vendor, including built-in configuration options. Further useful tips are also available in the press release to sponsors on computerised systems published on the EMA website in the GCP Q&As section. According to ICH GCP (6.4.9), the protocol should identify all data to be included directly in FIUs and be considered as sources. One of the most common results of on-site inspections is the lack of reliable, accurate and adequate documentation of the source. This is also the most common trap identified during sponsorship audits. The importance of good documentary practices should be stressed to audit bodies to ensure that the results of the study are based on credible and valid data. This article focuses on the most important principles of good documentary practice and proposes improvements. A standard work manual (SOP) should describe the packaging operations step by step, including the checks to be carried out at each stage and the responsibilities of each person involved. The legal status of audit subject data as personal data, whether coded or not, must be taken into account at all times by auditors and sponsors or by a third party working on behalf of the promoter, in particular when the data is transmitted to other parties. This relates, for example.
B to FIU data and edited copies of medical records. A few important factors are to be taken into account below: sponsors are assigning more and more tasks in clinical trials. In accordance with Article 7(1) of Directive 2005/28/EC and Article 71 of the Clinical Trials Regulation (EU 536/2014), any sponsor may delegate its tasks/functions to a person, undertaking, institution or organisation in relation to study trials. However, where tasks/functions are entrusted to third parties, the sponsor shall remain ultimately responsible for the compliance of the audit and the final data obtained from those examinations with the requirements of Regulation (EU) No 536/2014 and those of Directive 2001/83/EC in the event of an application for authorisation. This applies in particular to the safety of the subjects and the reliability and robustness of the data generated during the clinical trial. Other unmonitored medical records are discovered at the time of audits/inspections. If a sponsor cannot rely on the provision of documents by a supplier, the sponsor must requalify the system based on its own specifications and the specifications of the supplier`s system. . . .