What are the characteristics of source data documents? Finally, it provides a solid basis for data that is transcribed into a FRC, which is ultimately translated into a clinical study report. A standard operating procedure (SOP) should describe step-by-step packaging operations, including the controls to be carried out at each stage and the responsibilities of each person involved. The study/IP coordinators collaborate at the same time as different sponsors/CROs. These different sponsors/CROs communicate different expectations in terms of source documentation. If the site is not experienced enough and they do not have a standard procedure to follow, they can be confused with the variations in the guide they receive. This can have a negative impact on data quality. The 12 requirements of the discussion paper come from the CDISC standard and are therefore directly cited in the discussion paper. Although the CDISC requirements are specifically related to source data, the requirements will apply to EU inspectors as well as transcribed data, as indicated in the discussion paper section 6.2. Therefore, the requirement for a simultaneous and independent copy of the FRC applies, whether the FRC contains source data or only transcribed data. The inspectors of the European Union`s GCP believe 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 because the examiner does not contain a simultaneous and independent copy of the data. To understand the importance of good source documentation, we must first verify the purpose of source documentation. The main purpose of documenting the sources in a clinical trial is to reconstruct the study as it took place.

It should allow an independent observer to confirm the data again. Documents must be designed to provide an audit trail to allow for review where necessary. (“The contract should allow the client to review the outsourced activities of the contractor or its mutually agreed subcontractors”). The signature of the IP or the examiner`s authorized collaborator is considered a documented confirmation that the data entered and transmitted to the eCRF promoter is fact, readable, original, accurate and complete and simultaneous (ICH-GCP 4.9.1). Any officer authorized for the walkout (in accordance with ICH`s GCP 8.3.14) should be qualified to meet the purpose of the audit described below. Several data sets for the same data points, so they can`t determine what serves as an exact source file, for example. B for several versions of analog visual scales completed for the same visit with different values. The information must be documented at the same time as the flow of events within the appropriate time frame. If a clinical observation cannot be recorded when it is made, a timeline must be recorded. The amount of the delay allowed should be defined and justified. [4] In addition to the file documents, it is necessary to add to the file, during the course of the study, evidence that all new relevant information is documented as soon as it is available Many unreported EAs in the FRCs, delays in the transcriminalization of data in FRCs, discrepancies between source and FRC.

The lack of timely reporting of EAs in eCRFs compromises the security, reliability and integrity of data collected on the site. Essential documents are also used for a number of other important objectives. The timely presentation of essential documents to control centres/institutions and sponsor sites can greatly contribute to the proper management of a process by the auditor, promoter and monitor. These documents are generally verified by the promoter`s independent audit function and verified by the regulator as part of the procedure to confirm the validity of the test behavior and the integrity of the data collected.