Clinical Research Governance and Quality Assurance
The website provides useful information on : Planning Research, Sponsorship, Study Management, Standard Operating Procedures and Templates
Each project registered with DaSH will progress through the 7 stages of the DaSH process, as illustrated in the diagram below.
To start the process and discuss the requirements of your project contact us now at DaSH@abdn.ac.uk.
All enquiries are registered with DaSH and given a DaSH project number. Please use this project number in all communications with DaSH.
The DaSH team supports researchers through the robust governance processes to ensure safe research projects are undertaken by appropriately trained researchers; providing information about datasets, advice on data management plans and record keeping (for audit), and ensuring that any research findings are published without the risk of identifying individuals.
If appropriate, the DaSH team will arrange a ‘Project Initiation Meeting’ to discuss your project requirements and tell you about the support that DaSH has to offer. In advance of the meeting, you will be sent a Project Registration document to complete in preparation for the meeting.
Your Research Coordinator will advise you about the project and data permissions that you will need to consider and assist you in the preparation of a Data Management Plan (DMP). A DaSH analyst will prepare a Data Linkage Plan (DLP) for your project. The DMP and DLP are useful for funders and permissions providers.
The DaSH team will provide you with a cost for your funding application for the Safe Haven services you require. We can also provide you with text describing the Safe Haven environment if required.
It is important to understand the individual data sources from which you are requesting data. The DaSH team does not necessarily hold these data ‘in house’ so you should liaise with the Data Custodians to get information about the dataset(s).
To get the best research dataset for your project, you should carefully think about what data items (variables) you need. A detailed data specification helps you communicate this. DaSH can support you in the preparation of the data specification.
The range of datasets often used for linkage studies include the University held Aberdeen Maternity and Neonatal Databank (AMND), the national Scottish health records data held at NHS Information Services Division (ISD), disease specific cohorts held nationally such as Scottish Care Information - Diabetes Collaboration, or others held by the researchers undertaking the data linkage studies.
To view a larger list of University hosted datasets, visit the HIR@Aberdeen datasets page.
Researchers who want to use the Grampian Data Safe Haven (DaSH) facility must meet the following criteria:
1. To be employed by an approved institution (i.e. public sector institutions such as NHS, Scottish Government, universities, local authorities)
For commercial projects:
To access data in the safe haven there will be a contractual partnership with an approved research organisation (i.e. public sector institutions such as NHS, Scottish Government, universities, local authorities) in place.
If help is needed to arrange this, contact University of Aberdeen Research & Innovation or advise researchers to do so.
2. To be in possession of a valid certificate for one of the approved information governance training courses listed below.
Note: Training certificates must be kept up to date throughout the duration of the research project.
3. To have signed a DaSH investigator declaration for the study (usually signed by the study PI or equivalent, and if appropriate, the student researcher).
This requirement applies to University of Aberdeen researchers AND to external collaborators i.e. all external collaborators will need to sign a DaSH investigator declaration in addition to the study PI.
An approved training course for Information Governance is:
MRC Research, GDPR and Confidentiality Module (free e-learning)
Once all the permissions are in place, and ahead of data being transferred to or from DaSH, your Research Coordinator will arrange a ‘Pre Linkage" meeting with the data analysts to discuss the technical aspects of your project, so you can plan with the analyst team your project schedule.
Once a file is ready for you in your Safe Haven folder, you will be notified by the DaSH team. You then need to validate your data and check it against your data specification documentation to ensure it meets your requirements.
It is useful to check these as soon after receiving the files as possible. That way, your analyst in the Safe Haven (and the external data source provider) will still be able to address issues quickly.
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The project Principle Investigator and the research team continue to be responsible for good clinical research practice in relation the data, even though it is in the Safe Haven. The DaSH Investigator Declaration is the contract you will sign that summarises the key responsibilities which include:
Where no specific disclosure requirements are set by the Data Custodians, the minimum requirement is that no individual patient data record can be removed from the Safe Haven (i.e. no copy of the data files, rows of individual study participant data, or tables of statisitcis with cells with values of 1, or in some circumstances 0. Aggregated analysis results files can however be released once a DaSH Research Coordinator.
DaSH has been accredited by the Scottish Government (November 2017) and meets the Information Security and Governance standards outlined in the Charter for Safe Havens in Scotland 2015.
The DaSH approach ensures that researchers responsible for the custodianship of a dataset can retain rigorous control over who has access to their research data and a researcher cannot pass on the data without prior approvals. This is crucial to ensure that data is not subsequently combined with other data sources resulting in possible identification of individual patients.
DaSH comprises of state-of-the-art dedicated computer servers to safely store patient and public data. Identifiable data, crucial to enabling linkage of different datasets together, is stored within a dedicated NHS DaSH server, to the highest levels of security, whist the Virtual Private Network (VPN) and data storage server sits in the University of Aberdeen data centre. Access to these servers is controlled by the respective IT Departments.
During the linkage process one analyst extracts the cohort from the various datasets that the university holds and then assigns a pseudo-anonymised link number. This is then sent to the appropriate department, in the majority of cases NHS National Services Division (ISD), who then extract the data required and create a new file without the identifiable information, just the pseudo-anonymised link number. This new file is then sent to a second developer, who is not privy to the identifiable information, who then performs any additional linkage and a sense test before moving it into the dedicated area within the safe haven.
A sense test is performed before data release to allow for any possible mismatch in linkage to be identified. We also use this test to highlight any disease specific groups with small numbers of people. Expert advice is sought to determine whether there is a potential risk to patient confidentiality in the event that the disease is rare or uncommon.
Through DaSH, researchers safely access their data for analysis without the ability to copy, print, or transfer data outside the Safe Haven in anyway. Researchers access their data for analysis via the VPN in a dedicated secure folder within the Safe Haven and data is only released once DaSH is sure that all of the necessary approvals and permissions are in place and checks have been carried out.
A dedicated member of staff is responsible for the quality assurance of each project. Their remit is to ensure that each project has all the relevant paperwork completed and that the data is processed in line with the data management plan, data linkage plan and DaSH working protocols for security.