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.
Researchers who are considering undertaking a data linkage or hosting study should contact DaSH via DaSH@abdn.ac.uk. A project reference number (e.g. DaSHXXX) will be assigned. Please use this project number in all communications with DaSH.
DaSH will then email you a Project Initiation Document (PID) to complete prior to an initial meeting which is designed to gather further information on your proposed project.
Once the feasibility of your project has been confirmed, DaSH will provide support with:
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 ACHDS datasets page
If you are a local researcher (i.e. University of Aberdeen or NHS Grampian employee) wishing to access local NHS Grampian data, then North Node Permissions Advisory Committee ([NNPAC]) approval may be suitable. DaSH will be able to advise on whether your planned study meets the criteria.
The team will also assist you in the preparation of a Data Management Plan (DMP) and Data Linkage Plan (DLP) for your project. These documents illustrate the data flow, access conditions and researchers. The DMP and DLP are useful for funders and permissions providers.
Once funding and permissions are in place, and ahead of data being transferred to or from DaSH, a DaSH Research Coordinator will arrange a ‘Pre-linkage" meeting with the Data Analysts. This meeting is designed to allow researchers to meet with the Lead Analyst for their project, to discuss technical aspects and specifications, and to plan the project schedule with the analyst team.
Once a file is ready for you in your Safe Haven folder, you will be notified by the DaSH team. Prior to accessing the folder, your Research Coordinator will arrange a ‘Pre-Access’ meeting. This meeting is designed to ensure that all Researchers gaining access to the Safe Haven are aware of their responsibilities. It also allows for any questions to be addressed.
Once in the Safe Haven, you will need to validate your data and check it against your data specification documentation to ensure it meets your requirements.
It is useful to check your data as soon after receiving the files as possible. That way, your analyst in the Safe Haven (and the external data source provider) will be able to address issues quickly.
At the end of a project, it is the Principal Investigators responsibility to complete any required end of study reports (e.g. as requested by ethics or data custodians). Please note that projects which are ‘completed’ via sponsor cannot subsequently be amended. Therefore, if you wish to access your data for follow up work, extensions to project end dates should be sought when required.
DaSH will contact researchers at the end of the analysis period to confirm that the project can be closed and archived. The standard DaSH archiving period is 5 years, unless previously agreed with DaSH.
Researchers should ensure they read and adhere to the rules and responsibilities outlined in their project Data Management Plans, Investigator Declaration and access instructions.
This includes the following:
If you wish to remove outputs from the safe haven, the only method of removing results, outputs or information from your safe haven folder is to contact DaSH via DaSH@abdn.ac.uk and provide the names of the files/folders you want released. They will then be assessed by a DaSH Research Coordinator (or named statistician if appropriate) for risk to patient confidentiality prior to release.
Generally, outputs requested for release should:
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. Additionally, DaSH is accredited to ISO27001:2013 Information Security Management
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 analyst, 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.
Our staff 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.