The MHRA advice (2015) only says that it is “strongly advised” and “ When establishing an eHR system the following aspects should be considered”. It does not say that alternatives (work-arounds) that produce compliant system are not acceptable and only the MHRA (2015) recommendations are acceptable.

I have seen a Presentation by Jason Wakelin-Smith 2017, entitled “NHS Digital Reform: Enabling Clinical Trials?”. He describes Current Work-around to preserve subject confidentiality as being: • CRA provided with a site access to EHR; • Agreement to only view trial patients; • Site review of patient records accessed; • Company disciplinary process; • Trust based.”
I presume from this that these work-arounds are acceptable.

As can be seen from their list of problems found (2015) that “Inability to readily access audit trails” is a big concern. Without audit trails availability it will be impossible for the investigator site to “review patient records accessed”. If you look at the full quote of the 2015 guidance you can see that this is their major concern:-- “Access to the system should be available for inspectors and sponsor representatives (e.g. monitors and auditors), which is limited to trial patients. This will enable source data verification of clinical trial subjects whilst protecting the confidentiality of non-trial patients. This should include access to audit trails;”