![]() The source data printouts did not contain all the relevant source data.The limited information printed was not the entire health record as the patients’ medical history information was not present and sometimes there were gaps in the records during the trial (including adverse events recorded in the EHR) resulting in missing visits and data in the printed records. There were printouts of source documents from the EHR systems which the monitors had used for source data verification (SDV), but there was no evidence that these had been certified copies. ![]() The lack of appropriate functionality of the system resulted in researchers being required to print out records in an unsuccessful attempt to make certified copies of source documents/data, with additional procedures and resources required to do this. The system did not allow access limited to trial patients for external (and internal) monitors and therefore direct access had been denied to the monitor.Some examples of the issues we have identified include (but are not limited to) the following: Access & security At several trusts this consists of scanning all written records into the EHR and destroying original source documents (both historic records and current visits).Īs inspectors, we have seen various types of EHR on our investigator site inspections and in several cases we have given major findings where they did not meet the requirements of Good Clinical Practice (GCP). Although a national initiative, trusts are implementing this locally with different service providers. As you will be aware, in the UK there is a national NHS initiative to replace patients’ paper medical records with electronic health records (EHRs). ![]()
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