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The British Medicines and Healthcare Products Regulatory Agency (MHRA) has issued updated guidelines that explain how representatives designated by clinical trial sponsors to review and verify data at the trial site can perform tasks remotely
.
The monitoring and auditing of the test is essential to ensure the safety of test participants and the reliability of the results
The “Sponsor’s Representative’s Access to Electronic Health Records in Clinical Trials” guidelines issued by the MHRA on September 8 stated that remote monitoring can be achieved by allowing the sponsor’s designated clinical trial monitors/inspectors to directly access the trial subjects’ Electronic health records (EHR) should be completed, but appropriate security measures should be taken to ensure patient privacy
.
The guide explains that allowing direct remote access to the EHR can take many forms, such as:
Login access, in which the test inspector/inspector can log in to the EHR system remotely instead of on-site
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The visit is guided by video calls, where the research site/institution personnel use the screen of the EHR system to share or display the original paper records
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Since guided visits will bring more burdens to on-site staff, the guidelines point out that direct login access rights should be given priority to inspectors/inspectors
Upload access, where the research site/institution can upload a scanned or electronic copy of the source file to a secure portal provided by the trial sponsor (or representative) or the research site/institution
.
For each of the above direct access mechanisms, the guide outlines the various processes and systems that must be in place
.
For example, in the case of file sharing portals, the guidelines state that if these are provided by the sponsor, the researcher/institution must edit and smear any data that may directly or indirectly identify trial participants
In addition, after the inspector/inspector completes the review, all records in the portal should be deleted
.
The details of who will perform the deletion and when it will be performed should be pre-arranged between the sponsor and the investigator
Telnet access
Telnet access In order to support remote log-in access by test monitors/inspectors, the guide lists some key functions that EHR systems should normally have
.
For example, to prevent unnecessary and inappropriate copying and sharing of information from EHR, prohibit trial monitors/inspectors from inadvertently changing data in the system, and ensure that only representatives approved by the sponsor can access the EHR system
The guidelines point out that these problems can be solved by taking some measures, such as allowing test monitors/inspectors to have read-only access to the EHR system, setting up two-step authentication that allows read-only access, constructing "automatic timeout" clauses, and Restrict printing, copying, and downloading of information from the EHR system
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The guidelines also stipulate different control measures that sponsors and research sites/institutions must implement to support remote direct access to the EHR system
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For example, the sponsor should prepare and/or review a test monitoring plan to ensure that risk-proportionate methods are implemented to verify/review source data
In the case of EHR system incompatibility, MHRA stated that it is not acceptable to print out from EHR to support source data verification activities
.
The MHRA had earlier warned of this practice, and it has occurred in some test sites in the UK, which will cause improper disclosure, cause distress and harm to patients, data leakage and possible law enforcement actions
Remote monitoring during the epidemic
Remote monitoring during the epidemic Some EHR systems may not have the necessary functions to allow direct login access, whether remotely or on-site, and may not be able to introduce these functions immediately
.
MHRA has issued separate updated guidelines on short-term mitigation measures.
The guide recommends some temporary solutions for some missing functions in the EHR system, such as:
In the case that read-only access is not possible, the test site can check for improper modifications to the EHR system after the audit (or audit) review activity
.
If the two-step remote login access is unavailable, another method is that the remote monitor/inspector should use video contact with the venue to confirm their identity, and confirm that they log in to the EHR during each audit (or audit) review period The intent of the system
.
If the EHR system cannot restrict the printing, copying, or downloading of data, the sponsor or sponsor’s representative can provide the inspector/inspector with strong written training on the importance of this requirement
.
