NHS Digital Data Release Register - reformatted
Northern Ireland Clinical Trials Unit projects
1 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).
Opt outs honoured: Anonymised - ICO Code Compliant (Consent (Reasonable Expectation))
Legal basis: Health and Social Care Act 2012 s261(2)(c)
When:DSA runs 2022-01-24 — 2022-04-30
Access method: One-Off
Data-controller type: BELFAST HEALTH AND SOCIAL CARE TRUST
Sublicensing allowed: No
- MRIS - Personal Demographics Service
The expected benefit of the study was to show if simvastatin is effective in improving clinical outcomes in patients with ARDS. If this was not proven, there was still expected to be a benefit to publishing the results of the study, in that it should prevent similar research being carried out unnecessarily. The wider research community have access to the results of this study and should therefore be aware that simvastatin is not effective in improving clinical outcomes in patients with ARDS. This is expected to ensure that no undue risk and burden is put upon additional patients through a similar study to get the same results.
These outputs will generate new information to inform patient care and generate new research hypotheses to be tested to improve patient care. The benefits can be measured by the data generating future clinical trials, which inform patient care including informing in the guidelines for the care of patients with ARDS. This will be captured in Researchfish.
Data was released to BHSCT under Data Sharing Agreement DARS-NIC-155413 / MR1294. All anticipated data processing was carried out and outputs were produced as below.
1. Study Report, which has been uploaded onto the EudraCT System. The production of the study report for EudraCT is a regulatory requirement for a clinical trial of an Investigational Medicinal Product. The funder expected the study to be run in line with regulatory requirements. The funder as with all public sector funders has an expectation that the research will be disseminated via publication and appropriate data sharing of anonymised data.
2. The final study data was published in peer reviewed journal The New England Journal of Medicine.
3. A Final Report for funder Efficacy and Mechanism Evaluation Programme was produced.
The success of the trial depended on the collaboration of doctors, nurses and researchers from across the study sites. Therefore, the results of the trial werereported first to trial collaborators. The trial was reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines (www.consort-statement.org).
The findings were presented at national and international meetings with open access abstracts on-line and in accordance with the open access policies proposed by the leading research funding bodies. The findings were published in the New England Journal of Medicine. This secured a searchable compendium of these publications and the results were readily accessible to the public, health care professionals and scientists.
Due to limited resources, it was not possible to provide each surviving patient with a personal copy of the results of the trial. However, a laypersons summary of the principal findings of the results was sent to all patients involved in the study on their request. In addition, a laypersons summary was sent to local and national patient support and liaison groups (e.g. CritPaL, hospital patient groups). A report of the study findings was sent to the INVOLVE registry.
An ongoing update of the trial was provided on the HARP-2 trial website.
An approved data sharing agreement (DARS-NIC-155413 / MR1294) was created between the Northern Ireland Clinical Trials Unit (NICTU - part of the Belfast Health and Social Care Trust) and NHS Digital. Under this data sharing agreement, data was uploaded to NHS Digital for each patient as below:
Date of Birth
NICTU ID Number
Data was then downloaded from NHS Digital as below:
Status Alive or Dead
Date of Death
Date of Birth
NICTU ID Number
BHSCT did not receive any NHS numbers/ Dates of Birth from NHS Digital that were not already held by the Trust.
No onward sharing of NHS Digital data is permitted except in the form of aggregated data with small number suppression applied.
The data processing was carried out in accordance with the aims of the trial described in Objectives for Processing and all the outputs were produced (see Expected Outputs and Yielded Benefits). This all took place prior to the change of the Data Protection Act and introduction of the General Data Protection Regulations. A new data sharing agreement is required to enable retention of the data released under NHS Digitals historic data sharing framework as DARS-NIC-155413 / MR1294.
The trial received ethical approval from the Office for Research Ethics Committees Northern Ireland (ORECNI) on 08/09/2010.
Data processing is only carried out by substantive employees of the data processor(s) and or data controller(s) who have been appropriately trained in data protection and confidentiality. The ethical approval allowed the NICTU to hold patient names and addresses to allow them to be contacted before questionnaires were sent out. This was to prevent the NICTU sending out questionnaires to patients who had passed away. The key to identify the patients from their NICTU ID number was held electronically at the NICTU. This key was stored electronically (by the HARP-2 NICTU study team) within the NICTU Trial Master File, which is hosted on the BHSCT ICT servers. The access to this data is restricted to the HARP-2 study team only (for use on the study). No one else at the NICTU has access to this key and so the data was unidentifiable to everyone outside the study team.
The data from NHS Digital was received via secure file transfer from the Medical Research Information Service (MRIS) within NHS Digital. The data was stored electronically (by the HARP-2 NICTU study team) within the NICTU Trial Master File (TMF), which is hosted on the BHSCT ICT servers. The access to this data is restricted to the HARP-2 study team (for use on the study) and the Quality Assurance Manager (who has access to the Trial Master File to allow internal audits). No hard copy of this data exists. The NICTU TMF has all the documentation required under Good Clinical Practice (GCP) to be maintained for a clinical trials (e.g. contracts, communication, meeting minutes, regulatory approvals, database validations and approvals). This is on paper and in electronic format for most of the documentation but data received from the MRIS from NHS digital was only held in electronic form.
A version of this data with all identifiers (except the NICTU ID Number) removed was also placed on the MACRO database, which is hosted on the HSC Business Services Organisation (BSO) servers. The only data moved to this environment persistent from what was disseminated by NHS Digital is data derived from Date of Death field covered under this agreement. Date of death was converted into 28 day mortality status (alive/dead) which was used as part of the derivation for Ventilator Free days (VFDs) until day 28 which was the primary outcome on the HARP-2 trial. Data is being stored by both BHSCT and BSO but no longer being processed.
This data was entered onto the MACRO database by the HARP-2 study team. The MACRO system has password-protected access. BSO hosts the MACRO clinical study databases on their servers. BSO supply IT infrastructure for BHSCT and are therefore listed as data processors. They supply support to the system, but do not access data. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data. BT are subcontracted to house the BSO servers and they are a storage location / Organisation which is classed as Bricks and Mortar storage that houses the BSO IT infrastructure and cannot access the data. BT do not access data held under this agreement as they only supply the building. Therefore, any access to the data held under this agreement would be considered a breach of the agreement. This includes granting of access to the database[s] containing the data.
BSO was established on 1 April 2009 to provide a wide range of business and specialist professional services to the wider Health and Social Care (HSC) environment. BSO is an integral part of the HSC regional infrastructure in Northern Ireland.
Data in the MACRO system was moved from this system into the statistical software which is hosted on the BHSCT ICT servers. The software is held on files restricted to the statistical department. The data was analysed as per the Statistical Analysis Plan (SAP) and put into final reports in the form of aggregated data with small numbers suppressed.