For centralised applications, the Committee for Medicinal Products for Human Use (CHMP) often requests an inspection of one or more Sites of Good Clinical Practice (GCP). Before such GCP inspections, the European Medicines Agency (EMA) sends the applicant an information letter containing, inter alia, a list of the documents to be provided to the inspection team. The data is used by inspectors for verification to select patients and data for inspection. Among the requested documents are individual lists of patient data for patients recruited from the sites to be reviewed. Based on previous experience, this request for data lists represents a considerable number of problems and subsequently takes a lot of time for companies and inspectors, which often leads to sub-optimal quality lists. To understand the importance of good source documentation, we should first check the purpose of the source documentation. The main purpose of source documentation in a clinical trial is to reconstruct the study as it took place. It should allow an independent observer to repair the data. The documentation shall be such that it is capable of providing a test track in order to allow, if necessary, a study. 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. In requirement 10 of the discussion paper above, it is stated that “the sponsor should not have exclusive control of a source document.