Data Management
Plans for data entry, coding, security, and storage, including any related processes to promote data quality (eg, double data entry; range checks for data values). Reference to where details of data management procedures can be found, if not in the protocol.
Research Data Management Policy document.
- Description of the data
1.1 Type of study
Unblinded randomised controlled trial, with a nested cost-effectiveness evaluation
1.2 Types of data
Quantitative data on participant demographics and health status including liver disease and background
comorbidities.
Results of a Markov cost-effectiveness model including incremental cost effectiveness ratios
1.3 Format and scale of the data
All data will be collected once from all participants (n=640). Long-term outcomes including incident liver cancer
and death will be collected from routine health data after completion of the main study in accordance with
ethical approvals. Data will be entered into an Excel database (double entry) and transferred to SPSS (or like
databases) for statistical analysis. Databases will be password protected and stored securely on University of
Southampton computers. The results of statistical analyses will be recorded electronically as SPSS/R/Stata output
files. The Markov model and its outputs will be designed and stored on as University of Southampton computer. - Data collection/generation
2.1 Methodologies for data collection/generation
Data will be collected using validated questionnaires, validated tests for liver cirrhosis and laboratory methods.
All research will be conducted according to standard operating procedures (SOPs) and all staff will be fully
trained to assure competence. Any programmatic scripts produced to analyse these data will be made available
in a public repository (e.g github.com) under an open source licence
2.2 Data quality and standards
All laboratory and clinical methods will be performed in accordance with University of Hospital
Southampton/manufacturer guidance. SOPs will be followed and staff will be trained appropriately. Analyses will
be conducted in duplicate. A data analysis plan will be developed. Dual entry of data into Excel spreadsheets will
be used. - Data management, documentation and curation
3.1 Managing storing and curating data
Original hard copy data (e.g. questionnaires, consent forms, eligibility screening sheets) will be stored securely in
a locked cabinet within the University of Southampton in accordance with ethical approvals. Data will be (double)
entered into Excel spreadsheets on a regular basis; these will be password protected. These spreadsheets will be
backed up daily on the institutional server. Statistical analysis will be conducted in SPSS or other software where
more appropriate. Again such spreadsheets will be password protected and backed up.
3.2 The study will be registered as a clinical trial at www.clinicaltrials.gov. Once the findings from the trial are
published, the record will be updated to indicate that data are available from the PI upon request. The data will
be stored on the University of Southampton data repository (http://library.soton.ac.uk/researchdata) and
approved users will be given access to this. All data will be retained in this repository. - Data security and confidentiality of potentially disclosive information
4.1 Formal information/data security standards
The study will be compliant with the University of Southampton Data Protection Policy (May 2018) and the
General Data Protection Regulation 2016 (Data Protection Act 2018).
4.2 Main risks to data security
It is necessary to hold information on subjects’ names and contact details in order to contact them during the
study. However, such identifiable information will not be stored in any database along with study data. All
identifiable data will be kept in a password protected electronic file and in hard copy in a locked filing cabinet.
All data will be linked only to study codes and thus not identifiable with the source subject. However, the caveat
to this will be a data set recording the subject name and study code without any other subject details.
All data recorded on paper will be kept in a locked filing cabinet in the researchers’ office and/or in a dedicated,
restricted access, clinical data storage area (e.g. on Level D of the IDS Building, University of Southampton).
Data of an identifiable nature (i.e. subject names, contact details, addresses) will be destroyed after the end of
the project.
Data will be obtained, handled and stored in adherence to the principles set out in the General Data Protection
Regulation 2016 (Data Protection Act 2018). - Data sharing and access
5.1 Suitability for sharing
We will generate demographic data on ~640 patients with type 2 diabetes. These data are likely to be of interest
to other researchers.
5.2 Discovery by potential users of the research data
Publications from the study and end of study dissemination events (organised by the researchers and PPI
contributors) will indicate that data are available and how to approach the PI to gain approval for access to the
data. Once the main findings are published, the study record at www.clinicaltrials.gov will be updated to indicate
that data are available from the PI upon request. The data, including metadata, will be stored on the University
of Southampton data repository (http://library.soton.ac.uk/researchdata) and approved users will be given
access to this.
5.3 Governance of access
The data, including metadata, will be stored on the University of Southampton data repository
(http://library.soton.ac.uk/researchdata). Requests to access the data will be considered in a timely manner by
the joint-CIs – Ryan M Buchanan & Chris Byrne). Statistical models will be made available in R via GitHub and SBML via model repositories to enable reproduction of the results.
5.4 The study team’s exclusive use of the data
We will aim to publish our main findings in a timely manner (e.g. within 6 months of the end of the study). At that
stage notification of data availability will be widely disseminated through the publication(s) at the time of their
acceptance for publication.
5.5 Restrictions or delays to sharing, with planned actions to limit such restrictions
We do not anticipate such delays because study participants will consent to data sharing prior to study entry. No
identifiable personal data will be shared. Consequently we do not believe there will be any risk from sharing any
of the data generated in the study. - Responsibilities
The co-CIs will have overall responsibility for data management, metadata creation, data security and quality
assurance of data, Co-Is will each have responsibility for these activities at their sites. The Southampton
researchers will co-ordinate data management activities among the sites. - Co-funding with industry partners
Our study is co-funded with Echosens LTD. As per the terms of the contract between UoS and Echosens
Southampton University have full rights of ownership over the data. Southampton University will collect, store
and manage the sharing of data generated in this study without hinderance.