...data integrity, MHRA and FDA have produced a joint paper ‘Data Integrity in global Clinical Trials’ authored by those who presented at the event. Although UK and US legislation around...
...followed the first joint event back in 2018, which resulted in the following paper: https://mhrainspectorate.blog.gov.uk/2020/06/30/mhra-and-fda-joint-paper-data-integrity-in-global-clinical-trials/ We are pleased to say that, while the event seems like a world away from...
The first post in this series described the importance of organisational behaviour on the success of data integrity control measures. Behavioural issues are often unsuitable for technical guidance, but the...
The MHRA’s GXP data integrity guide has been published today. ‘GXP’ refers to the various good practices regulated by the UK MHRA, including the Good Laboratory Practice Monitoring Authority (GLPMA)....
The recently published guidance on data integrity provides an extensive description of the MHRA expectations of data integrity across the GxPs. This is not a new regulatory requirement but guidance...
...data listings (such as important safety laboratory results and electrocardiogram (ECG) data) PK data and other data outlined in the protocol for review was not present in the data provided...
...to patient (ePRO) reported data across a number of trials; The changes had been requested by the sponsor’s data management team in conjunction with investigator site staff; Data changes were...
...integrity has always been a fundamental aim of the GLP and GCP regulations, consequently the focus of inspections will not change substantively. However the route used to verify data integrity...
...be assured. Data migration – The MAH is responsible for data integrity when using a third party, risk of data loss needs to be minimised, especially during transfers. MHRA presented...
...starting the trial. The trial recruited to target in the timeframe with representation of each sub-age group for this population. Risk: Integrity of data Inevitably there is a risk to...
