BRC Clinical Records Interactive Search (CRIS) Usage Regulations

Background

CRIS provides a means of analysing anonymised data from the South London & Maudsley Foundation NHS Trust (SLAM) electronic case records. Ethical approval for such analyses was provided by Oxfordshire REC C National Research Ethics Service in September 2008 for a 5 year initial period and renewed in 2013. Access to clinical information is clearly a sensitive issue and a security model was developed which has been considered and approved by the SLAM Caldicott Guardian and the Trust Executive, as well as forming part of the ethics application.

Security Requirements of CRIS use

CRIS can only be accessed from the SLaM network. Data from CRIS must be kept within the Trust firewall and can only be saved on the CRIS shared drive on SLaM computers. CRIS data CANNOT be saved on personal or encrypted USB sticks. CRIS data CANNOT be emailed from SLAM machines to your personal email or King’s email. Please be aware that all data also has to be analysed within the SLAM firewall. You are not allowed to analysis CRIS data using King’s College or King’s Hospital or your own personal statistical software on our personal computers. Please also note that currently STATA, SPSS and SAS are the only statistical programmes that are available at the Nucleus

The security model includes regular audits of searches carried out using CRIS (all searches by all users are recorded and can be audited). For this to be possible, we keep a record of all projects carried out involving CRIS analysis along with general specification of the type of searches which will be required.

Ethics and research governance approval assume anonymity of the data analysed. As with any dataset, there is the potential within this database to compromise anonymity by generating unique variable combinations or rare categories. CRIS users are asked to consider whether this issue may occur and strategies to avoid compromising anonymity (Question 8 will provide scope to cover this). Alternatively they may wish to obtain specific ethics approval for an analysis where this risk is likely to be significant. Searching under clinician’ names are a sensitive issue; this type of information in research would have to be justified.

Rationale for Application Process

An oversight committee led by the BRC Stakeholder Participation theme will review all requests to use CRIS as an anonymised database. It is important for the BRC to demonstrate that SLAM clinical data are used responsibly and for projects with demonstrable research and clinical importance.

The future of CRIS, as with other aspects of BRC research, depends on successful bids for future funding. This in turn requires evidence of use of the database, hence the need to keep a record of individual projects.

The CRIS oversight committee has a role in facilitating CRIS analyses and to advise on how best to extract robust data. The database is potentially complex and users will be encouraged to collaborate and share expertise and hands-on experience. The information submitted in the project application form will be used to provide a database for this purpose to assist future researchers.