Source Document Agreement

Similarly, source documentation issues ranked 5th among the top 10 results of inspections carried out by the European Medicines Agency (EMA) in 2009[1] and, in some cases, the results were considered “critical”. It`s no surprise that clinical trial monitors and auditors also point to documentation issues as a common area of concern for the GCP. I would like to highlight here in detail some of the conclusions drawn from the warnings. These results provide an idea of regulatory expectations and documentation gaps identified during inspections. I`m sure readers would be able to identify some of these findings with their personal experience. This definition describes the different types of documents that together make up the source document. It is therefore necessary to exercise great diligence to ensure that the division of labour is clearly documented and agreed, that each party has control and access to the data and information required by its legal responsibilities and that the ethics committees and regulatory authorities authorising studies have been duly informed of those activities as part of the clinical trial application procedure. The 12 requirements of the discussion paper are derived from the CDISC standard and are therefore cited directly in the discussion paper. Although the CDISC requirements relate specifically to source data, EU inspectors consider that the requirements are also applicable to transcribed data, as set out in the reflection paper, section 6.2.

Therefore, the need for a simultaneous and independent copy of the FIU applies whether the FIU contains source data or only transcribed data. The EU PCM inspectors consider that the above requirement is not met when the data is collected in an electronic system and the data is stored on a central server under the exclusive control of the sponsor. This is due to the fact that the investigator does not have a simultaneous and independent copy of the data. In accordance with the recently published discussion paper on expectations for source data and electronic data that are transcribed into clinical trials into electronic data collection tools, a detailed diagram and description of the transmission of electronic data should be included in the minutes. The source data and their respective collection methods should be clearly defined prior to the recruitment of subjects (i.e. in the protocol or in a study-specific source data agreement).

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