NHS Digital Data Release Register - reformatted

Royal Papworth Hospital NHS Foundation Trust projects

13 data files in total were disseminated unsafely (information about files used safely is missing for TRE/"system access" projects).


MesobanK (ODR1516_410) — DARS-NIC-656770-J1L3N

Type of data: information not disclosed for TRE projects

Opt outs honoured: Identifiable, Anonymised - ICO Code Compliant (Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006)

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (NHS Trust)

Sensitive: Non-Sensitive, and Sensitive

When:DSA runs 2023-10-11 — 2026-10-10

Access method: One-Off

Data-controller type: ROYAL PAPWORTH HOSPITAL NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. NDRS Cancer Registrations
  2. NDRS Linked HES APC
  3. NDRS Linked HES Outpatient
  4. NDRS National Radiotherapy Dataset (RTDS)
  5. NDRS Systemic Anti-Cancer Therapy Dataset (SACT)

Objectives:

The Royal Papworth NHS Foundation Trust MesobanK study has a remit to collect, process and despatch human tissue, pleural fluid and blood samples from NHS patients with clinically proven mesothelioma to support asbestos-related research.

Tissue, pleural fluid and blood samples are procured from NHS patients who either have a clinically proven diagnosis of mesothelioma or are suspected of having the disease.

The patient's name and NHS number are entered onto the database by staff at the donor centre so that follow-up information can be collected about that patient's disease progression, treatment and other outcomes at a later date - information will be pulled from the NHS Cancer Registries.

Clinically annotated biospecimens will be inwardly shared to support applications from researchers undertaking biomedical research directly concerned with asbestos-related disease diagnosis and treatment.

Royal Papworth Hospital NHS Foundation Trust requires access to NHS England data for the purpose of the following research project: Mesobank.

Mesobank has two cohorts of patients.

1) A prospective cohort of recruited patients via consent.
2) A retrospective cohort of around 100 deceased patients which is covered by s251 CAG (no further data will be requested for the retrospective cohort).

The following datasets are required:

NDRS Cancer registrations
NDRS Anti-Cancer Therapy (SACT) data
NDRS Radiotherapy Data Set (RTDS) data
NDRS HES admitted care
NDRS HES outpatient data

The level of the data will be pseudonymised

The data will be minimised as follows:
Limited to data for a study cohort identified by Royal Papworth Hospital NHS Foundation Trust
• Mesobank participants where extant consent remains in place (or s251 approval for the retrospective deceased cohort).
• Limited to conditions relevant to the study identified by specific ICD and OPCS codes
• Treatment data provided will be for the 3 months prior to and 24 months post diagnosis

Royal Papworth Hospital NHS Foundation Trust is the research sponsor and the data controller and the organisation responsible for ensuring that the data will only be processed for the purpose described above.

The lawful basis for processing personal data under the UK GDPR is:
Article 6 (1) (e): processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller.

The lawful basis for processing special category data under the UK GDPR is:
Article 9 (2) (j): processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The processing is in the public interest because it aims to produce clinically annotated biospecimens that researchers can use when undertaking biomedical research directly concerned with asbestos-related disease diagnosis and treatment. Mesothelioma is a rare cancer that arises from the pleura and peritoneum often following exposure to asbestos. Whilst there is a long latency between exposure to asbestos and the development of disease, an individual’s prognosis following diagnosis is generally poor with a median survival of 9-12 months. Owing to its historically high levels of asbestos use, the UK has the world’s highest incidence of mesothelioma per head of population.

Mesobank operates on a cost recovery basis and has also received research grants from several charities including:

Mick Knighton Mesothelioma Research Fund
Asthma and Lung UK (formerly the British Lung Foundation
The Victor Dahdaleh Foundation
The June Hancock Mesothelioma Research Fund

None of the listed funders have been involved in any decision making processes or development in the scope of the research undertaken by MesobanK.

A number of groups were involved in setting up Mesobank:
Mesothelioma UK
Greater Manchester Asbestos Victims Support Group
Papworth Hospital Mesothelioma Support Group

The national data opt-out does not apply where explicit consent has been obtained from the patient for the specific purpose.

Where individuals have opted out of disease registration by the National Disease Registration Service (NDRS), their data has been permanently removed from the registry and therefore will not be disseminated under this Data Sharing Agreement (DSA). https://digital.nhs.uk/ndrs/patients/opting-out

Yielded Benefits:

To date, Mesobank have supplied samples for use in over 50 different research projects. It usually takes many years for laboratory research to produce advances in the way diseases are diagnosed, treated or prevented.

Expected Benefits:

Mesothelioma is a rare incurable cancer that arises from the pleura and peritoneum often following exposure to asbestos. Whilst there is a long latency between exposure to asbestos and the development of disease, an individual’s prognosis following diagnosis is generally poor with a median survival of 9-12 months. Owing to its historically high levels of asbestos use, the UK has the world’s highest incidence of mesothelioma per head of population. The data will be used to produce clinically annotated biospecimens that will be made available to researchers undertaking biomedical research directly concerned with the prevention, diagnosis and treatment of mesothelioma. It is hoped that these clinically annotated biospecimens will enable us to better understand how mesothelioma develops from its early stages and translate this into more effective diagnosis and treatment for patients.

Processing:

Data Recipient will transfer direct identifiers to enable tumour level linkage to data held by the NCRAS. Where there is an unambiguous match, NCRAS will provide the Data Recipient with pseudonymised clinical data for each matched data subject.

Data processing is only carried out by substantive employees of Royal Papworth Hospital NHS Foundation Trust who have been appropriately trained in data protection and confidentiality.
Pseudonymised NCRAS clinical data is stored on secure network drives and access to folders is restricted

Royal Papworth Hospital NHS Foundation Trust will transfer the data below to NHS England for the cohort to be linked with NHS England data.

NHS number
Surname
Forename
Date of birth
Postcode of residence
Trust of diagnosis of mesothelioma
Date of diagnosis of mesothelioma
Primary diagnosis (ICD 10)
MesobanK ID

NHS England will provide the relevant records from the datasets below. The data will contain no direct identifying data items but will contain a unique person ID which can be used to link the data with other record level data already held by the recipient:

AV_patient data
MesobanK ID
ETHNICITY
VITALSTATUS (patientstatus)
VITALSTATUSDATE Split into two, date if dead (deathdate
and lastalivedate)
DEATHCAUSECODE_1A
DEATHCAUSECODE_1B
DEATHCAUSECODE_1C
DEATHCAUSECODE_2

AV_tumour data
MesobanK ID
Tumour ID (pseudonymised)
SITE_ICD10_O2
LATERALITY
BASISOFDIAGNOSIS
MORPH_ICD10_O2
BEHAVIOUR_ICD10_O2
T_BEST
N_BEST
M_BEST
DIAGNOSISDATEBEST
Previouscancers Derived field

AV_treatment data
Tumour ID (pseudonymised)
CHEMO_ALL_DRUGS
CHEMO_DRUG_GROUP
OPCS4_CODE
EVENTDATE
EVENTDESC

AV_Systematic Anti-Cancer Therapy (SACT) data
MESOBANK ID (pseudonymised)
Analysis_Group
Start_Date_of Regimen
Number_of_Cycles_Delivered Derived field

AV_National Radiotherapy Data Set (RTDS) data
MESOBANK ID (pseudonymised)
Treatmentstartdate
rttreatmentanatomicalsite
RTDS_PRESCRIPTIONS.RTTREATMENTM
ODALITY

AV_linked HES admitted care and outpatient data
MESOBANK ID (pseudonymised)
Opertn OPCS codes:
'E391','E398','E399','E441','E461','E541',
'E542','E543',
'E544','E545','E548','E549','E552','E559','T0
13','T023','E554','E551'
'T01','T02','T03','T05','T07','T08','T09',
'T10','T11','T12','T13','T14','T15','T16','T17'
Opdate


The data will be stored on servers at Royal Papworth Hospital NHS Foundation Trust

The data will not be transferred to any other location, except when the servers are backed up and the data is copied to tape and encrypted. Royal Papworth Hospital NHS Foundation Trust uses offsite back-up storage services. Data is copied to tape, encrypted and stored offsite at Iron Mountain. Iron Mountain only provide the physical storage location for backup purposes and have no access to/nor process the Mesobank data.

The data will be accessed onsite at the premises of Royal Papworth Hospital and by authorised personnel via remote access. The data will remain on the servers at Royal Papworth Hospital at all times except when backed up and sent to the offsite storage facility at Iron Mountain.

Access is restricted to individuals within the Research and Development Department of Royal Papworth Hospital who have authorisation from the Head of Department to access certain project specific (Mesobank) folders. All such individuals are substantive employees of Royal Papworth Hospital.

All personnel accessing the data have been appropriately trained in data protection and confidentiality.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset. There will be no requirement and no attempt to reidentify individuals when using the pseudonymised dataset.

Staff that work on MesobanK from Royal Papworth Hospital will process the data for the purposes described above.

Data will not leave England or Wales at any time.


Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) — DARS-NIC-139146-W7C3P

Type of data: information not disclosed for TRE projects

Opt outs honoured: Anonymised - ICO Code Compliant, No (Consent (Reasonable Expectation))

Legal basis: Health and Social Care Act 2012 – s261(2)(c)

Purposes: No (NHS Trust)

Sensitive: Sensitive, and Non-Sensitive

When:DSA runs 2021-02-22 — 2024-02-21 2021.10 — 2023.10.

Access method: Ongoing

Data-controller type: ROYAL PAPWORTH HOSPITAL NHS FOUNDATION TRUST

Sublicensing allowed: No

Datasets:

  1. Civil Registration (Deaths) - Secondary Care Cut
  2. HES:Civil Registration (Deaths) bridge
  3. Hospital Episode Statistics Admitted Patient Care
  4. Civil Registrations of Death - Secondary Care Cut
  5. Hospital Episode Statistics Admitted Patient Care (HES APC)

Objectives:

Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) are requesting Hospital Episodes Statistics (HES) and mortality data for use in the Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) study. The ETTAA study (The NIHR grant reference is: HTA Project:11/147/03 - Effective Treatments for Thoracic Aortic Aneurysms) is a prospective cohort study which commenced in 2014. The intent is to link the study cohort to the NHS Digital data to facilitate complete patient follow up and ensure that any key events (death and/or admission to hospital) and key resources used in hospital have not been missed.

Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) are the sole Data Controller who also process data.

The lawful basis for processing personal data for ETTAA is Article 6(1)(e) and Article 9(2)(j): Performance is in the public interest because, NIHR (HTA) commissioned the ETTAA study to try and identify Effective Treatments for Thoracic Aortic Aneurysms. such research is part of the official business of the hospital. Processing under Article 9(2)(j) is necessary for the scientific validity of the data to meet the outputs described below, subject to appropriate safeguards. The data processing to is necessary for reasons of substantial public interest - i.e., fulfilling the NIHR approved grant funded research and the data requested is proportionate to the study objectives.

The proposed project data will allow Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) to validate the existing ETTAA study data (collected by local study coordinators), ensuring that dates and causes of death are complete and accurate by linking to Civil Registration Deaths data, and by linking to the HES Admitted Patient Care data, so that any admissions to hospital and key resources used in hospital are reflected accurately in the ETTAA data set. It will also facilitate a complete follow up of all patients receiving a procedure in the latter months of the study observation period.

The incidence of chronic thoracic aortic aneurysm (CTAA) is rising as the UK population ages and will therefore pose an increasing challenge to health care providers and policy-makers. Based on an estimated incidence of 6-16 affected/100,000 people-year, there are 3000 – 8000 new cases per year. These patients are at risk of both fatal and non-fatal complications of the condition and the subsequent treatment costs for these patients are high. There are limited data describing the natural history of CTAA because it is often asymptomatic until presentation with rupture or dissection. Patients referred for elective intervention were usually diagnosed coincidentally during investigations for other conditions. The risk of rupture or dissection is related to size and rate of growth of the aneurysm, but these two factors alone are not sufficient to predict risk of rupture, dissection or death, since fatal complications occur even while the aneurysm is small. Control of blood pressure and smoking cessation help to reduce the risk of rupture or dissection but there is a greater risk reduction after endovascular stent grafting (ESG) or open surgical repair (OSR). Both ESG and OSR are known to be effective but each has limitations and cannot always be offered to all patients. OSR is a durable intervention but is more invasive with higher early mortality and morbidity than ESG. ESG is, however, only applicable when arterial morphology is suitable and is known to be less durable. Therefore, patient and aneurysm factors must be considered jointly while deciding upon a treatment.

Data Subjects are patients with Chronic Thoracic Aortic Aneurysm (CTAA) referred to each collaborating centre who have consented to participate in the ETTAA study.

Inclusion criteria:
• Aged over 18 years
• Had a Chronic Thoracic Aortic Aneurysm (CTAA) larger than or equal to 4cm on the arch or descending aorta
• Were able to give informed consent.

Exclusion criteria:
• Intervention required below the level of the coeliac axis
• Have acute dissection or malperfusion syndromes (such as myocardial infarction, acute stroke or limb ischaemia)

The comparison groups are:

ESG: Endovascular repair of the aneurysm via transluminal introduction of a stent-graft under X-ray guidance. Hybrid procedures that comprise a combination of a conventional surgical component and a transluminal repair are to be included in this group.

OSR: Replacement of the aneurysmal aorta with prosthetic conduit via a surgical incision with circulatory support.

CM: These patients have aneurysms that merit procedural intervention; however this is not planned either due to patient choice, co-morbidities or risk assessment. This refers to lifestyle modification (smoking cessation and dietary management) as well as medical management of hypercholesterolaemia and hypertension for patients who are considered unsuitable for, or who refuse, OSR / ESG.

WW: Patients with small aneurysms considered to be at low risk of rupture will remain under surveillance with annual CT / MRI scans and MDT review (as per local practice). These patients’ data will contribute to the natural history component of the study.

The objectives of the ETTAA study are:

1. To follow patients with CTAA referred to each collaborating multidisciplinary team (MDT), prospectively recording management, medical events, Quality of Life (QoL) and use of health and social services throughout the duration of the study.

2. To quantify clinical outcomes in each cohort (WW, CM, ESG, OSR) in terms of survival and quality of life.

3. To identify patient -specific or aneurysm-specific features that might predict poor outcome in each treatment group by risk-modelling methods.

4. To estimate the clinical- and cost-effectiveness of competing treatments to define optimal management strategies for patients in whom more than one treatment is considered appropriate.

Data required includes: date of death, cause of death, dates of admission to and discharge from hospital. information about the clinical events associated with the hospital admission and key resources used in hospital and on discharge.

Civil registration deaths data is requested to provide mortality data.
HES data is requested to provide clinical event and hospital use data.

Study Number, NHS number and Date of Birth are provided, with patient consent for identification purposes. NHS Digital will provide pseudo-anonymised data identified by study number only.

Data is requested from 2014 to 2020. This is to maximise the number of patient years of follow up, to get closer to the original study plan whilst staying within the resources of the original grant.

When the study was planned the ETTAA study team predicted that a maximum of 2200 participants would be recruited from 8-9 UK aortic centres over 4 years. The first patient was recruited in March 2014. By the end of 2014, more centres were opened to boost recruitment. By July 2016 the ETTAA team reported to the HTA Monitoring Group that there were 26 UK centres open to recruitment and 402 patients had been recruited. The Health Technology Assessment (HTA) gave permission to continue to open new centres to recruit to ETTAA. Between 24th March 2014 and 24th July 2018, 874 CTAA patients were recruited from 30 centres. Although some centres specialised in either vascular or cardiac surgery, many centres recruited patients to all four management groups.

Between 24th March 2014 and 24th July 2018, 874 CTAA patients were recruited:
Version 1 (Patient recruitment 23/12/2013 – 10/03/2014) = 0
Version 2 (Patient recruitment 10/03/2014 – 09/07/2014) = 0
Version 3 (Patient recruitment 09/07/2014 – 27/07/2015) = 159
Version 4 (Patient recruitment 27/07/2015 – 24/06/2018) = 715

This is the most non-intrusive, scientifically valid and cost effective way to ensure complete patient follow up and to validate the existing ETTAA study data set.

Only data needed to complete the study validation and statistical and health economic data analyses has been requested.

Expected Benefits:

It is hoped that the ETTAA study will directly address the research question specified in the NIHR HTA brief ‘What is the clinical and cost-effectiveness of various management strategies for chronic thoracic aortic aneurysm (CTAA)?’ The aim is to produce robust information to answer this question and, in the process, 1) assist clinical decision making by individual patients and healthcare professionals; and, 2) inform NHS Policy and resource allocation.

Any assessment of the clinical and cost-effectiveness of various management strategies for chronic thoracic aortic aneurysm (CTAA) are of public interest as the costs are funded from public funds and it is members of the public who develop aortic aneurysms that requires NHS treatment.

• The disseminated results (reports, publications and presentations) will provide the current background, descriptive evidence based on the ETTAA study results and assessment of how the findings of this observational study add to the evidence available to answer the above question.

Discussion within and around the research publications and presentations will inform the DoH, aortic specialists and the public on what has been observed and what this might mean for future practice and future research.

ETTAA will provide published cost-effectiveness analyses and general published literature (e.g. journal articles) and the ETTAA team will work with clinicians and professional bodies across the UK to revise clinical guidelines – should the study provide strong enough evidence to warrant changes.

The data requested in this application is essential to validate the data collected by study coordinators throughout the ETTAA study before any recommended changes in policy or practice are made based on the study results.

Accurate event data (hospital admission for adverse events and dates and causes of death) will provide more reliable clinical outcomes and cost effectiveness estimates of the different treatment options for CTAA.

The longer the patients are followed up, the more reliable long term outcome predictions and estimates of event free survival and resource use will be. The requested data will improve the quality of information provided for patients and the NHS.

The HTA monograph will include an overview of all the study outputs which will subsequently be prepared as journal articles and presentations for publication/delivery in Spring 2021. Further work on aneurysm growth and longer term follow up outcomes (if funding allows) will be reported in 2024.

Crucially, an economic analysis is required to assist future resource allocation. Evidence to date is retrospective and as such is limited. In this prospective study design, the planned risk modelling methods have the potential to assist in matching patients to the most appropriate treatments. The use of the MDTs will reduce the impact of the selection biases that confound previous data. The study will also permit (although it is not the primary aim) an analysis of referral patterns and patient characteristics across the UK due to the geographical location of collaborating clinical centres. The proposed study design will recruit patients and observe practice and results from a variety of NHS institutions across the country. Completion of the project will yield a nationwide ‘picture’ of the patient groups presenting with CTAA.

The study will secure:
1. information for medics to relay to their patients regarding their prognosis and expected quality of life
2. evidence to assist clinicians in choosing the most appropriate treatment for each patient
3. guidance to NHS management in planning the distribution of appropriate services.

It will also provide an evidence base for the role of MDTs in aortic surgery with a view to establishing an aortic network(s) to provide comprehensive, standardised care across the UK.

Outputs:

The study will culminate in a HTA monograph describing the study and its results in detail, which will
allow the Trust to make recommendations for practice and policy in the UK.

The findings from this study will also be reported locally, nationally and internationally in the form of presentations and journal articles to medical professionals and patient groups. This information will also be available via patient information leaflets and the study website which will be designed with the help of the patient representatives. Presentations may need to be online as medical conferences and public meetings are currently limited due to COVID-19.

It is anticipated that there will be a number of publications describing:
• Changes in aneurysm size over time
• Clinical events and relationship to aneurysm size
• Selection criteria for ESG, OSR and CM
• Factors affecting outcomes after ESG and OSR
• Comparative clinical outcomes after ESG and OSR in those patients that were eligible
for both treatments
• QoL and cost-effectiveness in patients for whom more than one treatment is
appropriate.

An analysis of patient specific and aneurysm specific factors (if there are any) which predict good or poor outcome will be provided. This will allow draft guidelines to be prepared regarding indications for ESG or OSR in patients with CTAA.

Dissemination of study results to the public will all be aggregated with small numbers suppressed, in line with the HES Analysis Guide. The data will be processed by members of the study team who already have access to patient information and have a contractual duty of confidentiality.

The ETTAA study has a publication committee and publication plan and the exact journals will be chosen when the papers have been drafted - however these are likely to be chosen from a general medical journal (Lancet, BMJ) or Cardiac surgery or Vascular surgery specialist journals as well as Statistical or Heath Economic publications.

Open Access articles will be made available whenever possible. (RPHNHST) PPI representative will be invited to present, or arrange for ETTAA team members to present, the results to Aortic Aneurysm groups and the study team will arrange presentations for study participants. Due to Covid 19 these are likely to be online presentations but face to face meetings may be considered it the situation changes and funding is available to complete these safely.

Processing:

A cohort list of all Effective Treatments for Thoracic Aortic Aneurysms (ETTAA) participants will be provided to NHS Digital, the ETTAA study will include Study ID number, Date of Birth and NHS number to identify the patients. The study ID will allow NHS Digital to flow back pseudonymised data to Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT). Once this is received, Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) will link NHS Digital data to the ETTAA study and will only use the study ID for linkage, there will be no attempt to re identify.

Along with the study ID, pseudo-anonymised Hospital Episodes Statistics (HES) Admitted Patient Care (APC) and Mortality data linked to the study cohort will be provided by NHS Digital to Royal Papworth Hospital NHS Foundation Trust (RPHNHSFT) as detailed above, this will include - where applicable - date of death, date of admission and discharge from hospital, reason for admission by way of diagnosis codes and resources used including procedures, Healthcare Resource Group (HRG) spells, dates and discharge details matched by Date of Birth and NHS number.

Royal Papworth Hospital NHS Foundation trust (RPHNHST) will then match the data received from NHS Digital with the current ETTAA data set using the Study ID, this will then be used to validate and complete the data set prior to further statistical and health economic data analyses. The statisticians or health economists will only have access to pseudo-anonymised datasets for analysis.

Royal Papworth Hospital NHS Foundation trust (RPHNHST) will provide the cohort data, provided from the existing study spreadsheet, and will be submitted to NHS Digital with NHS number and Date of Birth and Study ID.

NHS Digital will provide linkage of the (RPHNHST) cohort to HES APC and Mortality data and return data extracts containing Study ID only, the Study ID will allow NHS Digital to flow back pseudonymised data to (RPHNHST).

Variables provided by NHS Digital will be matched to existing variables in the ETTAA data set and the data will be compared. Where the data confirms existing information, this will be noted, and no further actions is required. Where information is additional to existing study data this will be provided as a separate variable for the analysts to use as they consider most appropriate after discussion with the study Working group, which consists of the Royal Papworth Hospital NHS Foundation Trusts, Trials Unit, including a former researcher of Royal Papworth Hospital NHS Foundation Trust, working on the ETTAA study, who has recently moved to the London School of Hygiene and Tropical Medicine. An honorary contract is in place for this user only and there will be no other access to the data by LSHTM.

Any conflicting information will be discussed in detail by the working group and if necessary, clarification will be sought from the Principal Investigator whose team originally recruited and followed up the patient.

NHS Digital data will only be linked to the ETTAA data set and no other linkage will be permitted.

NHS Digital will remove NHS number and Date of Birth and will only provide the Study ID back to (RPHNHST) which will then be returned to the ETTAA team.

The only exception to the above is if the ETTAA study follow up is formally extended in the future with HRA/REC approval and with an approved amendment to the DARS Data sharing Agreement.

Data processing NHS Digital data will only be carried out by substantive employees of Royal Papworth Hospital NHS Foundation Trust who have been appropriately trained in data protection and confidentiality.

Data is stored on a secure NHS hospital server with access only available to substantive employees of the data processor(s) / data controller(s).

NHS Digital reminds all organisations party to this agreement of the need to comply with the Data Sharing Framework Contract requirements, including those regarding the use (and purposes of that use) by “Personnel” (as defined within the Data Sharing Framework Contract ie: employees, agents and contractors of the Data Recipient who may have access to that data).