MyMelanoma Study - NHS DigiTrials Recruitment Service
University of Oxford · Academic
In term In term in the September 2026 edition: the latest version runs to 5 February 2028.
- Reference
- DARS-NIC-743571-K7X4R
- Current version
- v2.3
- Term of current version
- 6 February 2026 to 5 February 2028
- Start date
- 1 November 2024
- Data controller
- Sole Data Controller
- Commercial purposes
- No
- Sublicensing
- No
- Files released to date
- 0
Why the data was released
Objective for processing
The University of Oxford requires access to NHS England data for the purpose of the MyMelanoma study.
The following is a summary of the aims of the study provided by the University of Oxford:
The primary aim of MyMelanoma is to recruit and maintain contact with a large group of melanoma patients to build the biggest melanoma data resource ever collected in the UK. The University of Oxford hope this resource will enable researchers to answer key unanswered questions about melanoma. These questions can be grouped under the following aims:
Increasing what is known about susceptibility to melanoma and the long-term cancer risks in carriers of high-risk susceptibility genes
The identification of lifestyle and genetic factors playing a role in melanoma development, progression, response to treatment and survival
The effects of melanoma diagnosis, treatment and associated side effects have on the quality of life of melanoma patients and survivors
The identification of prognostic and predictive biomarkers
Increasing knowledge of the biology which underlies tumour progression and the interaction between the host (immunology), the host’s environmental exposures and the tumour
Any individual residing in England, who has been treated for a melanoma arising from the skin, genitalia, nail web, eye or mucosal surface, by the NHS is eligible to participate in MyMelanoma.
For the MyMelanoma Study to achieve its objectives, 20,000 people will need to be recruited.
MyMelanoma is part of a series of recruitment pilots testing new user cases and capabilities for minimal viable product (MVP) NHS DigiTrials recruitment service. As part of the pilot, the University of Oxford will provide suitable feedback regarding response rates to the invitations in order for NHS DigiTrials to undertake suitable analysis of the service.
The following NHS England Data will be accessed:
* Demographics – necessary for the purposes of identifying individuals who are eligible to participate in the MyMelanoma Study; and providing key information to the third-party messaging provider who have been contracted to contact potential participants.
Although the Hospital Episode Statistics dataset(s) are being cross-referenced to identify potential participants, these datasets are not considered as data products on this Data Sharing Agreement as no record level data from these dataset(s) will be provided to University of Oxford or the mailing provider. The processing of these datasets is covered under a separate Data Processing Agreement between NHS England and University of Oxford.
The level of the Data will be identifiable – necessary because the third-party messaging provider require enough information to be able to contact potential participants.
The Data will be minimised as follows:
Limited to individuals identified by NHS England as meeting the following criteria:
* Reside within England
* Male or Female
* Age 18 years or over
* Have a record of melanoma (based on the relevant ICD-10 code in the Hospital Episode Statistics data)
The University of Oxford are the research sponsor and the controller as 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.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for involvement in the MyMelanoma Study.
University of Oxford will promote this information via their study webpage and NHS England will also promote this information via a dedicated opt-out webpage for the study on its website. This will replicate the format used for other NHS DigiTrials Recruitment Pilots, and will be published shortly after this Agreement is approved. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection. As a result, their details will not be on the list passed to the third-party mailing provider (PSL Print Management Ltd and Datagraphic Ltd – see more information below) for invitations to be sent.
The funding is provided by Cancer Research UK (CRUK) Oxford Centre (University of Oxford) grant. The funding is for the MyMelanoma study but is not specifically limited to the MyMelanoma study. Funding is in place until 2030.
The funder will have no ability to suppress or otherwise limit the publication of findings.
NHS England are acting as a Processor on behalf of the University of Oxford and are responsible for:
1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees
2. Feeding back to University of Oxford the number of invitees actually fulfilled out of the total target population.
3. Removing objections or opt outs (where a national Data opt-out or a study-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to the third-party provider (Datagraphic Ltd) or NHS Notify for generating the invitation letters.
5. Agreeing with University of Oxford key processing timelines
6. Overseeing performance of Datagraphic Ltd and alerting performance issues to University of Oxford
7. Feeding back to University of Oxford performance in relation to Key Performance Indicators (KPIs) of Datagraphic Ltd and NHS England (inc. NHS Notify)
8. Where the number of potential invitees is less than the population available, invoking a system to choose invitees at random
9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations, as may be applicable.
10. Deploying the use of NHS Notify to manage the distribution of the invitations via approved third-party communication suppliers and maintaining an audit log of communications sent, delivery status and associated metadata. They will also ensure secure destruction of the letters and reporting back of returns data to the PDS team for the purposes of supporting data accuracy.
PSL Print Management Ltd are acting as a processor on behalf of NHS England and are responsible for maintaining a service contract with NHS England and managing the mailout performed by Datagraphic Ltd. PSL Print Management Ltd will not receive, store or have access to NHS England record level Data under this DSA. *
Datagraphic Ltd are acting as a processor on behalf of NHS England and PSL Print Management Ltd and are responsible for receiving the list of updated cohort participants from NHS England and mailing out to them accordingly.*
* PSL Print Management Ltd and Datagraphic Ltd work in partnership to provide robust, secure and time critical communication solutions. PSL Print Management Ltd provide project management, training and implementation skill and knowledge. Datagraphic Ltd develop, maintain and host the systems that enable secure and resilient communication to occur. Datagraphic Ltd also provide secure data processing, document composition, sortation, mail item production, enclosing, despatch and inbound mail services from their UK Midlands based development and production hub. NHS England maintains a service contract with PSL Print Management Ltd, and Datagraphic Ltd, in turn, are contracted to PSL, therefore both organisations are considered Processors in this DSA.
NHS England’s “NHS Notify” service is an alternative service for posting of invitation letters. NHS Notify is an NHS England service which enables a centralised standardised way to send and manage communications. NHS Notify utilise mailing services of third-party mailing providers. Reference to NHS Notify in this Data Sharing Agreement includes NHS Notify-approved third-party suppliers.
The University of Oxford leads on all study activity. Individuals from University of the Highlands and Islands (UHI), the NHS, and Melanoma Focus sit on the Study Management Group (an oversight committee) and provide input in an advisory capacity.
A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above.
All study participants including members of the public with relevant lived experience of melanoma (including current and past melanoma patients) are routinely invited to attend virtual meetings with key members of the study and research teams (referred to as MyMelanoma Participant Panel Meetings).
A Participant Panel meeting on 26th March 2024 was used to discuss the proposed use of the NHS DigiTrials Recruitment Service, including the acceptability of processing identifiable patient data without consent. The virtual meeting lasted 1hr 20mins and was attended by 16 volunteers. During the meeting, background information was provided on the Recruitment Scheme, the role of NHS England, how certain data supports the type of melanoma research MyMelanoma hopes to facilitate in the future, and why increasing recruitment numbers is essential in meeting study aims.
Additionally, the process of obtaining centrally held information and using this to send out study invitations was explained to attendees. Based on information provided during the session, discussion topics included:
• General acceptability. How do participants feel about receiving letters regarding potential research participation? Are centralised letters an effective way to communicate research opportunities to potential participants?
• Impact on participation. Do participants believe study invitation letters would encourage or discourage melanoma patients from participating in research?
• Inclusivity. Do centralised letters help ensure inclusivity in research participation? Are there any specific groups or communities that may face barriers in responding to study invitation letters?
• Feedback mechanisms. What mechanisms would you recommend for individuals to provide feedback or seek clarification after receiving a study invitation letter?
In summary, no attendee opposed the idea of MyMelanoma making use of the NHS DigiTrials Recruitment Scheme. Similarly, it was concluded that the potential benefits increased recruitment may bring out-weigh the potential risks. MyMelanoma participants are continuously encouraged to provide feedback on all study activity and procedures throughout the lifetime of the study at any time by contacting the study team.
Commercial entities may become involved in the research programme in the following way: Applying for use of the MyMelanoma Resource, in order to be used in future cancer research. This involvement is expected to generate a better understanding of melanoma biology, through research focused on the prevention, early-detection and treatment of melanoma. Results from such studies may lead to significant benefits for the cancer population.
Processing activities
University of Oxford will provide to NHS England the core eligibility criteria for those potential participants who will receive invitations.
NHS England will use the criteria provided by University of Oxford to identify potential participants who meet the criteria. NHS England will remove any records where a National Data Opt-Out or study-specific opt-out has been registered, as well as special categories of people for whom the data should not be disseminated.
NHS England will provide the relevant records of the identified potential participants from the Personal Demographics Service dataset to Datagraphic Ltd or the NHS Notify service via Secure Electronic File Transfer (SEFT). The Data will contain directly identifying data items including Title, First Name, Surname, Address and Postcode, which are required for the purposes of contacting potential participants. Datagraphic Ltd will also receive additional fields which will enable them to ensure that the correct invitation format and template are used for each round of invitations. Datagraphic Ltd will use Research Ethics Committee-approved template invitation letters.
NHS England will also provide an aggregate data quality report with small numbers supressed containing information about gender, age and geographic demographics of the mailing to University of Oxford. This report will also contain the total number of people who received the letter from Datagraphic Ltd, and the number of people removed from the cohort prior to mailing based on trial-specific opt out, national data opt out, and special categories of people for whom the data should not be disseminated, such as those on a witness protection programme.
Where the NHE Notify Service is used the Data will be transferred to an NHS Notify Service contracted mailing provider.
Otherwise, data will not be transferred to any other location. Datagraphic Ltd will contact individuals as specified by University of Oxford. All potential participants will receive a letter containing their Forename, Surname, address, postcode and an invitation QR code.
The invitation letters are refined via participant engagement and then tested in live settings, as outlined below.
Datagraphic Ltd or NHS England will send out invitations using an automated system.
The Data will be stored on servers at Datagraphic Ltd or NHS Notify service contracted mailing provider.
Processing will be from secure locations within England. The Data will not leave England at any time.
Access is restricted to substantive employees of NHS England and Datagraphic Ltd only. University of Oxford will only see participant data once a person signs up to the MyMelanoma study.
The University of Oxford and other recruiting sites will not have access to NHS England Data as described in this Data Sharing Agreement. The University of Oxford and other recruiting sites will not have access to individual’s data unless they are contacted directly by said individual following the mailout.
All personnel accessing the Data have been appropriately trained in data protection and confidentiality
Data sent to Datagraphic Ltd will not be linked with any other data.
Datagraphic Ltd will destroy all data files received from NHS England 2 weeks post mail-out, as instructed by NHS England.
Each time NHS England create and disseminate an extract, the records will be added to a mailing list cohort dataset. Should a fresh extract be produced, it will be checked to ensure that any records appearing in this mailing list dataset are removed in order to prevent potential participants receiving multiple invitations. This mailing list dataset will be maintained for six months after the invitation process is complete in case this is required for analysis purposes by University of Oxford, however it is anticipated that the data quality report will meet the trial's needs for monitoring how many individuals from different demographics were contacted in each 'mailing'. Only aggregated data would be used for such analysis.
Expected output
The expected outputs of this recruitment Agreement will be the University of Oxford reaching their recruitment target for the MyMelanoma Study, having sent adequate numbers of invitations to potentially eligible participants.
Progress against recruitment targets will inform:
* Establishing a large-scale, accessible research resource to support current and future melanoma research globally.
* Development of novel, translational research questions with potential scientific, medical and societal benefit
* Potential future academic and commercial collaborations with the aim of progressing cancer research.
Any reports will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. Identifiable health data will only be used to identify and invite potential participants.
The outputs will be communicated to relevant recipients through the following dissemination channels:
* Social media
* Press/media engagement
* Participant newsletters
Additionally, people who consent to take part will receive update emails annually giving news about how the research is progressing, news items from other participants, invitations to new projects to consider taking part in and seeking information on any new treatments received. Participants will of course be able to unsubscribe from this at any point.
The results of any tests performed on samples will not be returned to participants. The principal reason is that because the tests are being performed for research, therefore the significance for MyMelanoma participants of test results will not be clear until much later. Additionally, due to the scope and size of the study, it would also not be feasible to feedback results with the necessary support for participants. Research groups based in Oxford and the NHS are carrying out projects to devise mechanisms to address this issue and MyMelanoma study could utilise these systems if possible, at a later stage.
The single exception to this will be taken for people taking part in Route to Entry 3, with melanoma in their family. People who are considering participation in this study will be provided before consenting with additional information on what taking part means to them and what MyMelanoma would be able to do if a potentially important finding was made.
The University of Oxford hope to reach their recruitment target for the MyMelanoma study by 30th June 2026.
Expected measurable benefits
Achieving the recruitment target for the study is expected to enable the aims of the study to be realised, namely:
This resource will enable researchers to answer key research questions around melanoma, including:
* Why are some people more prone to develop melanoma, and what factors modify a genetic risk of melanoma?
* What are the long-term cancer risks in people who carry a genetic risk of melanoma?
* Are there biomarkers that can help identify those who are more likely to respond well to different treatments?
* What effects does a melanoma diagnosis, treatment and associated side effects have on the quality of life of people diagnosed with a melanoma?
* What is the biology underlying secondary melanomas and how is the immune system involved?
* What lifestyle factors play a role in melanoma?
The use of the Data from the NHS DigiTrials recruitment service could:
• inform study planning and decisions on how to improve equity in participation.
• support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).
Monitoring recruitment rate directly associated from the recruitment service will help determine whether the service can be used in future studies planned by the University of Oxford. Metrics derived from reports provided by DigiTrials will help identify sub-group populations which may be underrepresented in the overall cohort, driving future recruitment strategy aiming to maximise accessibility to research.
The ability to utilise large message quantities will help to optimise recruitment, in order to deliver the MyMelanoma study in a timely, effective and efficient manner. Using NHS England’s NHS DigiTrials Recruitment Service to generate mailing lists, in order to send invitations to members of the public about joining the MyMelanoma study is expected to significantly increase the recruitment reach of the study.
Participants will not benefit directly from signing up to the study, but the data they provide, and data generated from any samples they donate, will further research progress which may benefit others with similar health conditions in the future.
Recruiting individuals into the MyMelanoma study, using the NHS DigiTrials recruitment service, is ultimately expected to provide benefits to health and social care by creating the biggest melanoma data resource ever collected in the UK.
This resource will enable researchers to answer key research questions around melanoma, including:
* Why are some people more prone to develop melanoma, and what factors modify a genetic risk of melanoma?
* What are the long-term cancer risks in people who carry a genetic risk of melanoma?
* Are there biomarkers that can help identify those who are more likely to respond well to different treatments?
* What effects does a melanoma diagnosis, treatment and associated side effects have on the quality of life of people diagnosed with a melanoma?
* What is the biology underlying secondary melanomas and how is the immune system involved?
* What lifestyle factors play a role in melanoma?
The study team engage with various stakeholders and influencers to ask for their support with engaging members of the public who are eligible to join the MyMelanoma Study. They will be asked to raise awareness of the MyMelanoma study via their own communication channels which will increase familiarity and trust to the letter invite, for example:
* MyMelanoma website
* GP Practices
* Hospitals
* Integrated Care Boards
* Cancer Alliances
* Research Delivery Networks
* Charities
* Councils
* Healthwatch
* Community Organisations and groups
Benefits reported so far
NHS DigiTrials has sent approximately 150,000 and approximately 15,400 participants have been recruited.
Datasets on the current version
Legal basis for provision: Health and Social Care Act 2012 - s261(5)(d)
| Dataset | Type of data | Sensitivity | Frequency | Confidential data |
|---|---|---|---|---|
| Customer - Data Quality Report - Aggregate (Recruitment) | Anonymised - ICO Code Compliant | Non-Sensitive | One-Off | Section 251 NHS Act 2006 |
| Mailing - Cohort - Non-aggregate (Comms & Recruitment) | Identifiable | Sensitive | One-Off | Section 251 NHS Act 2006 |
Files released
Files released counts only files released externally by DARS. Access granted in NHS England's own systems, such as its Secure Data Environment, is not included.
No files recorded as released under this agreement.
Version history
The register lists each renewal of this agreement as a separate row. This site has 3 versions.
DARS-NIC-743571-K7X4R-v2.3 6 February 2026 to 5 February 2028
- Title
- MyMelanoma Study - NHS DigiTrials Recruitment Service
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Recruitment); Mailing - Cohort - Non-aggregate (Comms & Recruitment)
What changed from DARS-NIC-743571-K7X4R-v1.4
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2026-02-06 | |
| End date | 2028-02-05 | |
| Customer - Data Quality Report - Aggregate (Recruitment): common law duty of confidentiality | Section 251 NHS Act 2006 | |
| Mailing - Cohort - Non-aggregate (Comms & Recruitment): common law duty of confidentiality | Section 251 NHS Act 2006 |
Objective for processing
The University of Oxford requires access to NHS England data for the purpose of the
following study:
MyMelanoma study.
MyMelanoma study.
[9 paragraphs unchanged]
To recruit this number of individuals, it is expected that 170,000 individuals will need to be invited to the MyMelanoma Study using the NHS DigiTrials Recruitment service. NHS England may identify further eligible individuals to be contacted about the MyMelanoma Study, should the recruitment target not be met.
[1 paragraph unchanged]
MyMelanoma is performing a Study Within a Trial (SWAT) to evaluate the uptake of participants to the study, based on the invitation letter received. Whilst this SWAT does not form part of this Data Sharing Agreement, NHS England will be processing data on behalf of the University of Oxford but there will be no release of personal data outside of this DSA.
[16 paragraphs unchanged]
The Health Regulatory Authority (HRA) Confidentiality Advisory Group (CAG) provided support to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002, for the purpose of contacting potentially eligible participants.
[8 paragraphs unchanged]
4. Sending the list of invitees on to the third-party provider (Datagraphic Ltd)
or NHS Notify
for generating the invitation letters.
[2 paragraphs unchanged]
7. Feeding back to University of Oxford performance in relation to Key Performance Indicators (KPIs) of Datagraphic Ltd and NHS England
(inc. NHS Notify)
[2 paragraphs unchanged]
10. Deploying the use of NHS Notify to manage the distribution of the invitations via approved third-party communication suppliers and maintaining an audit log of communications sent, delivery status and associated metadata. They will also ensure secure destruction of the letters and reporting back of returns data to the PDS team for the purposes of supporting data accuracy.
[3 paragraphs unchanged]
NHS England’s “NHS Notify” service is an alternative service for posting of invitation letters. NHS Notify is an NHS England service which enables a centralised standardised way to send and manage communications. NHS Notify utilise mailing services of third-party mailing providers. Reference to NHS Notify in this Data Sharing Agreement includes NHS Notify-approved third-party suppliers.
[2 paragraphs unchanged]
All study participants including members of the public with relevant lived experience
[18 words unchanged]
of the study and research teams (referred to as MyMelanoma Participant Panel
Meetings)
Meetings).
[8 paragraphs unchanged]
Processing activities
[2 paragraphs unchanged]
NHS England will provide the relevant records of the identified potential participants from the Personal Demographics Service dataset to Datagraphic Ltd
or the NHS Notify service
via Secure Electronic File Transfer (SEFT). The Data will contain directly identifying
[45 words unchanged]
of invitations. Datagraphic Ltd will use Research Ethics Committee-approved template invitation letters.
NHS England will also provide an aggregate data quality report with small numbers supressed containing information about gender, age and geographic demographics of the mailing to University of
Oxford for the purposes of confirming that inclusion and exclusion criteria have been met for each mailing.
Oxford.
This report will also contain the total number of people who received
[35 words unchanged]
should not be disseminated, such as those on a witness protection programme.
Data will not be transferred to any other location. Datagraphic Ltd will contact individuals as specified by University of Oxford. All potential participants will receive a letter containing their Forename, Surname, address, postcode and an invitation QR code.
Where the NHE Notify Service is used the Data will be transferred to an NHS Notify Service contracted mailing provider.
Otherwise, data will not be transferred to any other location. Datagraphic Ltd will contact individuals as specified by University of Oxford. All potential participants will receive a letter containing their Forename, Surname, address, postcode and an invitation QR code.
[1 paragraph unchanged]
Datagraphic Ltd
or NHS England
will send out invitations
in approximately 10 batches of 17,000 letters - (up to approximately 170,000 total mailouts)
using an automated system.
The Data will be stored on servers at Datagraphic
Ltd.
Ltd or NHS Notify service contracted mailing provider.
[7 paragraphs unchanged]
Expected output
[5 paragraphs unchanged]
Any reports will not contain NHS England Data and will only contain
[15 words unchanged]
for the dataset(s) from which the information was derived. Identifiable health data
requested from NHS England
will only be used to identify and invite potential participants.
[7 paragraphs unchanged]
The University of Oxford hope to reach their recruitment target for the MyMelanoma study by 30th June
2025.
2026.
Benefits reported
None yet recorded - amendment to add Performance Uptake Report as part of Study Within a Trial (SWAT)
NHS DigiTrials has sent approximately 150,000 and approximately 15,400 participants have been recruited.
Unchanged: Expected measurable benefits.
DARS-NIC-743571-K7X4R-v1.4 2 January 2025 to 1 January 2026
- Title
- MyMelanoma Study - NHS DigiTrials Recruitment Service
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Recruitment); Mailing - Cohort - Non-aggregate (Comms & Recruitment)
What changed from DARS-NIC-743571-K7X4R-v0.2
Text removed is struck through; text added is underlined. Unchanged paragraphs are summarised rather than repeated.
| Field | Was | Became |
|---|---|---|
| Start date | 2025-01-02 | |
| End date | 2026-01-01 | |
| Customer - Data Quality Report - Aggregate (Recruitment): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Customer - Data Quality Report - Aggregate (Recruitment): common law duty of confidentiality | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 | |
| Mailing - Cohort - Non-aggregate (Comms & Recruitment): legal basis | Health and Social Care Act 2012 - s261(5)(d) | |
| Mailing - Cohort - Non-aggregate (Comms & Recruitment): common law duty of confidentiality | Mixture of confidential data flow(s) with consent and flow(s) with support under section 251 NHS Act 2006 |
Objective for processing
[13 paragraphs unchanged] MyMelanoma is performing a Study Within a Trial (SWAT) to evaluate the uptake of participants to the study, based on the invitation letter received. Whilst this SWAT does not form part of this Data Sharing Agreement, NHS England will be processing data on behalf of the University of Oxford but there will be no release of personal data outside of this DSA. [45 paragraphs unchanged]
Processing activities
No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).
University of Oxford will provide to NHS England the core eligibility criteria for those potential participants who will receive invitations.
[1 paragraph unchanged]
NHS England will provide the relevant records of the identified potential participants from the Personal Demographics Service dataset to Datagraphic
Ltd.
Ltd via Secure Electronic File Transfer (SEFT).
The Data will contain directly identifying data items including Title, First Name,
[39 words unchanged]
of invitations. Datagraphic Ltd will use Research Ethics Committee-approved template invitation letters.
NHS England will also provide an aggregate
data quality
report with small numbers supressed containing information about gender, age and geographic
[71 words unchanged]
should not be disseminated, such as those on a witness protection programme.
The
Data will not be transferred to any other location. Datagraphic Ltd will
[14 words unchanged]
letter containing their Forename, Surname, address, postcode and an invitation QR code.
[4 paragraphs unchanged]
Access is restricted to substantive employees of NHS England and Datagraphic Ltd only.
University of Oxford will only see participant data once a person signs up to the MyMelanoma study.
[2 paragraphs unchanged]
The
Data
sent to Datagraphic Ltd
will not be linked with any other data.
[2 paragraphs unchanged]
Benefits reported
Yielded Benefits is not a requirement for new applications.
None yet recorded - amendment to add Performance Uptake Report as part of Study Within a Trial (SWAT)
Unchanged: Expected output, Expected measurable benefits.
Objective for processing
The University of Oxford requires access to NHS England data for the purpose of the following study:
MyMelanoma study.
The following is a summary of the aims of the study provided by the University of Oxford:
The primary aim of MyMelanoma is to recruit and maintain contact with a large group of melanoma patients to build the biggest melanoma data resource ever collected in the UK. The University of Oxford hope this resource will enable researchers to answer key unanswered questions about melanoma. These questions can be grouped under the following aims:
Increasing what is known about susceptibility to melanoma and the long-term cancer risks in carriers of high-risk susceptibility genes
The identification of lifestyle and genetic factors playing a role in melanoma development, progression, response to treatment and survival
The effects of melanoma diagnosis, treatment and associated side effects have on the quality of life of melanoma patients and survivors
The identification of prognostic and predictive biomarkers
Increasing knowledge of the biology which underlies tumour progression and the interaction between the host (immunology), the host’s environmental exposures and the tumour
Any individual residing in England, who has been treated for a melanoma arising from the skin, genitalia, nail web, eye or mucosal surface, by the NHS is eligible to participate in MyMelanoma.
For the MyMelanoma Study to achieve its objectives, 20,000 people will need to be recruited.
To recruit this number of individuals, it is expected that 170,000 individuals will need to be invited to the MyMelanoma Study using the NHS DigiTrials Recruitment service. NHS England may identify further eligible individuals to be contacted about the MyMelanoma Study, should the recruitment target not be met.
MyMelanoma is part of a series of recruitment pilots testing new user cases and capabilities for minimal viable product (MVP) NHS DigiTrials recruitment service. As part of the pilot, the University of Oxford will provide suitable feedback regarding response rates to the invitations in order for NHS DigiTrials to undertake suitable analysis of the service.
MyMelanoma is performing a Study Within a Trial (SWAT) to evaluate the uptake of participants to the study, based on the invitation letter received. Whilst this SWAT does not form part of this Data Sharing Agreement, NHS England will be processing data on behalf of the University of Oxford but there will be no release of personal data outside of this DSA.
The following NHS England Data will be accessed:
* Demographics – necessary for the purposes of identifying individuals who are eligible to participate in the MyMelanoma Study; and providing key information to the third-party messaging provider who have been contracted to contact potential participants.
Although the Hospital Episode Statistics dataset(s) are being cross-referenced to identify potential participants, these datasets are not considered as data products on this Data Sharing Agreement as no record level data from these dataset(s) will be provided to University of Oxford or the mailing provider. The processing of these datasets is covered under a separate Data Processing Agreement between NHS England and University of Oxford.
The level of the Data will be identifiable – necessary because the third-party messaging provider require enough information to be able to contact potential participants.
The Data will be minimised as follows:
Limited to individuals identified by NHS England as meeting the following criteria:
* Reside within England
* Male or Female
* Age 18 years or over
* Have a record of melanoma (based on the relevant ICD-10 code in the Hospital Episode Statistics data)
The University of Oxford are the research sponsor and the controller as 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.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The Health Regulatory Authority (HRA) Confidentiality Advisory Group (CAG) provided support to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002, for the purpose of contacting potentially eligible participants.
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for involvement in the MyMelanoma Study.
University of Oxford will promote this information via their study webpage and NHS England will also promote this information via a dedicated opt-out webpage for the study on its website. This will replicate the format used for other NHS DigiTrials Recruitment Pilots, and will be published shortly after this Agreement is approved. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection. As a result, their details will not be on the list passed to the third-party mailing provider (PSL Print Management Ltd and Datagraphic Ltd – see more information below) for invitations to be sent.
The funding is provided by Cancer Research UK (CRUK) Oxford Centre (University of Oxford) grant. The funding is for the MyMelanoma study but is not specifically limited to the MyMelanoma study. Funding is in place until 2030.
The funder will have no ability to suppress or otherwise limit the publication of findings.
NHS England are acting as a Processor on behalf of the University of Oxford and are responsible for:
1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees
2. Feeding back to University of Oxford the number of invitees actually fulfilled out of the total target population.
3. Removing objections or opt outs (where a national Data opt-out or a study-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to the third-party provider (Datagraphic Ltd) for generating the invitation letters.
5. Agreeing with University of Oxford key processing timelines
6. Overseeing performance of Datagraphic Ltd and alerting performance issues to University of Oxford
7. Feeding back to University of Oxford performance in relation to Key Performance Indicators (KPIs) of Datagraphic Ltd and NHS England
8. Where the number of potential invitees is less than the population available, invoking a system to choose invitees at random
9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations, as may be applicable.
PSL Print Management Ltd are acting as a processor on behalf of NHS England and are responsible for maintaining a service contract with NHS England and managing the mailout performed by Datagraphic Ltd. PSL Print Management Ltd will not receive, store or have access to NHS England record level Data under this DSA. *
Datagraphic Ltd are acting as a processor on behalf of NHS England and PSL Print Management Ltd and are responsible for receiving the list of updated cohort participants from NHS England and mailing out to them accordingly.*
* PSL Print Management Ltd and Datagraphic Ltd work in partnership to provide robust, secure and time critical communication solutions. PSL Print Management Ltd provide project management, training and implementation skill and knowledge. Datagraphic Ltd develop, maintain and host the systems that enable secure and resilient communication to occur. Datagraphic Ltd also provide secure data processing, document composition, sortation, mail item production, enclosing, despatch and inbound mail services from their UK Midlands based development and production hub. NHS England maintains a service contract with PSL Print Management Ltd, and Datagraphic Ltd, in turn, are contracted to PSL, therefore both organisations are considered Processors in this DSA.
The University of Oxford leads on all study activity. Individuals from University of the Highlands and Islands (UHI), the NHS, and Melanoma Focus sit on the Study Management Group (an oversight committee) and provide input in an advisory capacity.
A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above.
All study participants including members of the public with relevant lived experience of melanoma (including current and past melanoma patients) are routinely invited to attend virtual meetings with key members of the study and research teams (referred to as MyMelanoma Participant Panel Meetings)
A Participant Panel meeting on 26th March 2024 was used to discuss the proposed use of the NHS DigiTrials Recruitment Service, including the acceptability of processing identifiable patient data without consent. The virtual meeting lasted 1hr 20mins and was attended by 16 volunteers. During the meeting, background information was provided on the Recruitment Scheme, the role of NHS England, how certain data supports the type of melanoma research MyMelanoma hopes to facilitate in the future, and why increasing recruitment numbers is essential in meeting study aims.
Additionally, the process of obtaining centrally held information and using this to send out study invitations was explained to attendees. Based on information provided during the session, discussion topics included:
• General acceptability. How do participants feel about receiving letters regarding potential research participation? Are centralised letters an effective way to communicate research opportunities to potential participants?
• Impact on participation. Do participants believe study invitation letters would encourage or discourage melanoma patients from participating in research?
• Inclusivity. Do centralised letters help ensure inclusivity in research participation? Are there any specific groups or communities that may face barriers in responding to study invitation letters?
• Feedback mechanisms. What mechanisms would you recommend for individuals to provide feedback or seek clarification after receiving a study invitation letter?
In summary, no attendee opposed the idea of MyMelanoma making use of the NHS DigiTrials Recruitment Scheme. Similarly, it was concluded that the potential benefits increased recruitment may bring out-weigh the potential risks. MyMelanoma participants are continuously encouraged to provide feedback on all study activity and procedures throughout the lifetime of the study at any time by contacting the study team.
Commercial entities may become involved in the research programme in the following way: Applying for use of the MyMelanoma Resource, in order to be used in future cancer research. This involvement is expected to generate a better understanding of melanoma biology, through research focused on the prevention, early-detection and treatment of melanoma. Results from such studies may lead to significant benefits for the cancer population.
Expected output
The expected outputs of this recruitment Agreement will be the University of Oxford reaching their recruitment target for the MyMelanoma Study, having sent adequate numbers of invitations to potentially eligible participants.
Progress against recruitment targets will inform:
* Establishing a large-scale, accessible research resource to support current and future melanoma research globally.
* Development of novel, translational research questions with potential scientific, medical and societal benefit
* Potential future academic and commercial collaborations with the aim of progressing cancer research.
Any reports will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. Identifiable health data requested from NHS England will only be used to identify and invite potential participants.
The outputs will be communicated to relevant recipients through the following dissemination channels:
* Social media
* Press/media engagement
* Participant newsletters
Additionally, people who consent to take part will receive update emails annually giving news about how the research is progressing, news items from other participants, invitations to new projects to consider taking part in and seeking information on any new treatments received. Participants will of course be able to unsubscribe from this at any point.
The results of any tests performed on samples will not be returned to participants. The principal reason is that because the tests are being performed for research, therefore the significance for MyMelanoma participants of test results will not be clear until much later. Additionally, due to the scope and size of the study, it would also not be feasible to feedback results with the necessary support for participants. Research groups based in Oxford and the NHS are carrying out projects to devise mechanisms to address this issue and MyMelanoma study could utilise these systems if possible, at a later stage.
The single exception to this will be taken for people taking part in Route to Entry 3, with melanoma in their family. People who are considering participation in this study will be provided before consenting with additional information on what taking part means to them and what MyMelanoma would be able to do if a potentially important finding was made.
The University of Oxford hope to reach their recruitment target for the MyMelanoma study by 30th June 2025.
Benefits reported
None yet recorded - amendment to add Performance Uptake Report as part of Study Within a Trial (SWAT)
DARS-NIC-743571-K7X4R-v0.2 1 November 2024 to 31 October 2025
- Title
- MyMelanoma Study - NHS DigiTrials Recruitment Service
- Commercial
- No
- Sublicensing
- No
- Datasets
- 2
- Files released
- 0
Datasets: Customer - Data Quality Report - Aggregate (Recruitment); Mailing - Cohort - Non-aggregate (Comms & Recruitment)
Objective for processing
The University of Oxford requires access to NHS England data for the purpose of the following study:
MyMelanoma study.
The following is a summary of the aims of the study provided by the University of Oxford:
The primary aim of MyMelanoma is to recruit and maintain contact with a large group of melanoma patients to build the biggest melanoma data resource ever collected in the UK. The University of Oxford hope this resource will enable researchers to answer key unanswered questions about melanoma. These questions can be grouped under the following aims:
Increasing what is known about susceptibility to melanoma and the long-term cancer risks in carriers of high-risk susceptibility genes
The identification of lifestyle and genetic factors playing a role in melanoma development, progression, response to treatment and survival
The effects of melanoma diagnosis, treatment and associated side effects have on the quality of life of melanoma patients and survivors
The identification of prognostic and predictive biomarkers
Increasing knowledge of the biology which underlies tumour progression and the interaction between the host (immunology), the host’s environmental exposures and the tumour
Any individual residing in England, who has been treated for a melanoma arising from the skin, genitalia, nail web, eye or mucosal surface, by the NHS is eligible to participate in MyMelanoma.
For the MyMelanoma Study to achieve its objectives, 20,000 people will need to be recruited.
To recruit this number of individuals, it is expected that 170,000 individuals will need to be invited to the MyMelanoma Study using the NHS DigiTrials Recruitment service. NHS England may identify further eligible individuals to be contacted about the MyMelanoma Study, should the recruitment target not be met.
MyMelanoma is part of a series of recruitment pilots testing new user cases and capabilities for minimal viable product (MVP) NHS DigiTrials recruitment service. As part of the pilot, the University of Oxford will provide suitable feedback regarding response rates to the invitations in order for NHS DigiTrials to undertake suitable analysis of the service.
The following NHS England Data will be accessed:
* Demographics – necessary for the purposes of identifying individuals who are eligible to participate in the MyMelanoma Study; and providing key information to the third-party messaging provider who have been contracted to contact potential participants.
Although the Hospital Episode Statistics dataset(s) are being cross-referenced to identify potential participants, these datasets are not considered as data products on this Data Sharing Agreement as no record level data from these dataset(s) will be provided to University of Oxford or the mailing provider. The processing of these datasets is covered under a separate Data Processing Agreement between NHS England and University of Oxford.
The level of the Data will be identifiable – necessary because the third-party messaging provider require enough information to be able to contact potential participants.
The Data will be minimised as follows:
Limited to individuals identified by NHS England as meeting the following criteria:
* Reside within England
* Male or Female
* Age 18 years or over
* Have a record of melanoma (based on the relevant ICD-10 code in the Hospital Episode Statistics data)
The University of Oxford are the research sponsor and the controller as 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.
This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.
The Health Regulatory Authority (HRA) Confidentiality Advisory Group (CAG) provided support to temporarily lift the Common Law Duty of Confidentiality under section 251 of the National Health Service Act 2006 and its current Regulations, the Health Service (Control of Patient Information) Regulations 2002, for the purpose of contacting potentially eligible participants.
In addition to the National Data Opt-out, members of the public will be able to specifically request not to be contacted for involvement in the MyMelanoma Study.
University of Oxford will promote this information via their study webpage and NHS England will also promote this information via a dedicated opt-out webpage for the study on its website. This will replicate the format used for other NHS DigiTrials Recruitment Pilots, and will be published shortly after this Agreement is approved. NHS England will record these requests not to take part and ensure that anyone who has registered for this will be excluded from the cohort selection. As a result, their details will not be on the list passed to the third-party mailing provider (PSL Print Management Ltd and Datagraphic Ltd – see more information below) for invitations to be sent.
The funding is provided by Cancer Research UK (CRUK) Oxford Centre (University of Oxford) grant. The funding is for the MyMelanoma study but is not specifically limited to the MyMelanoma study. Funding is in place until 2030.
The funder will have no ability to suppress or otherwise limit the publication of findings.
NHS England are acting as a Processor on behalf of the University of Oxford and are responsible for:
1. Applying the inclusion and exclusion criteria from the invitation request to the datasets to generate a list of invitees
2. Feeding back to University of Oxford the number of invitees actually fulfilled out of the total target population.
3. Removing objections or opt outs (where a national Data opt-out or a study-specific right to object has been registered, as well as special categories of people for whom the data should not be disseminated. The purpose of the restriction is to ensure that patient information that might imply a location is protected.)
4. Sending the list of invitees on to the third-party provider (Datagraphic Ltd) for generating the invitation letters.
5. Agreeing with University of Oxford key processing timelines
6. Overseeing performance of Datagraphic Ltd and alerting performance issues to University of Oxford
7. Feeding back to University of Oxford performance in relation to Key Performance Indicators (KPIs) of Datagraphic Ltd and NHS England
8. Where the number of potential invitees is less than the population available, invoking a system to choose invitees at random
9. Maintaining a record of people invited and ensuring they are excluded from second rounds of invitations, as may be applicable.
PSL Print Management Ltd are acting as a processor on behalf of NHS England and are responsible for maintaining a service contract with NHS England and managing the mailout performed by Datagraphic Ltd. PSL Print Management Ltd will not receive, store or have access to NHS England record level Data under this DSA. *
Datagraphic Ltd are acting as a processor on behalf of NHS England and PSL Print Management Ltd and are responsible for receiving the list of updated cohort participants from NHS England and mailing out to them accordingly.*
* PSL Print Management Ltd and Datagraphic Ltd work in partnership to provide robust, secure and time critical communication solutions. PSL Print Management Ltd provide project management, training and implementation skill and knowledge. Datagraphic Ltd develop, maintain and host the systems that enable secure and resilient communication to occur. Datagraphic Ltd also provide secure data processing, document composition, sortation, mail item production, enclosing, despatch and inbound mail services from their UK Midlands based development and production hub. NHS England maintains a service contract with PSL Print Management Ltd, and Datagraphic Ltd, in turn, are contracted to PSL, therefore both organisations are considered Processors in this DSA.
The University of Oxford leads on all study activity. Individuals from University of the Highlands and Islands (UHI), the NHS, and Melanoma Focus sit on the Study Management Group (an oversight committee) and provide input in an advisory capacity.
A Public and Patient Involvement and Engagement group helped refine the purpose of the research. The group supported the collection of the data for the purposes described above.
All study participants including members of the public with relevant lived experience of melanoma (including current and past melanoma patients) are routinely invited to attend virtual meetings with key members of the study and research teams (referred to as MyMelanoma Participant Panel Meetings)
A Participant Panel meeting on 26th March 2024 was used to discuss the proposed use of the NHS DigiTrials Recruitment Service, including the acceptability of processing identifiable patient data without consent. The virtual meeting lasted 1hr 20mins and was attended by 16 volunteers. During the meeting, background information was provided on the Recruitment Scheme, the role of NHS England, how certain data supports the type of melanoma research MyMelanoma hopes to facilitate in the future, and why increasing recruitment numbers is essential in meeting study aims.
Additionally, the process of obtaining centrally held information and using this to send out study invitations was explained to attendees. Based on information provided during the session, discussion topics included:
• General acceptability. How do participants feel about receiving letters regarding potential research participation? Are centralised letters an effective way to communicate research opportunities to potential participants?
• Impact on participation. Do participants believe study invitation letters would encourage or discourage melanoma patients from participating in research?
• Inclusivity. Do centralised letters help ensure inclusivity in research participation? Are there any specific groups or communities that may face barriers in responding to study invitation letters?
• Feedback mechanisms. What mechanisms would you recommend for individuals to provide feedback or seek clarification after receiving a study invitation letter?
In summary, no attendee opposed the idea of MyMelanoma making use of the NHS DigiTrials Recruitment Scheme. Similarly, it was concluded that the potential benefits increased recruitment may bring out-weigh the potential risks. MyMelanoma participants are continuously encouraged to provide feedback on all study activity and procedures throughout the lifetime of the study at any time by contacting the study team.
Commercial entities may become involved in the research programme in the following way: Applying for use of the MyMelanoma Resource, in order to be used in future cancer research. This involvement is expected to generate a better understanding of melanoma biology, through research focused on the prevention, early-detection and treatment of melanoma. Results from such studies may lead to significant benefits for the cancer population.
Expected output
The expected outputs of this recruitment Agreement will be the University of Oxford reaching their recruitment target for the MyMelanoma Study, having sent adequate numbers of invitations to potentially eligible participants.
Progress against recruitment targets will inform:
* Establishing a large-scale, accessible research resource to support current and future melanoma research globally.
* Development of novel, translational research questions with potential scientific, medical and societal benefit
* Potential future academic and commercial collaborations with the aim of progressing cancer research.
Any reports will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived. Identifiable health data requested from NHS England will only be used to identify and invite potential participants.
The outputs will be communicated to relevant recipients through the following dissemination channels:
* Social media
* Press/media engagement
* Participant newsletters
Additionally, people who consent to take part will receive update emails annually giving news about how the research is progressing, news items from other participants, invitations to new projects to consider taking part in and seeking information on any new treatments received. Participants will of course be able to unsubscribe from this at any point.
The results of any tests performed on samples will not be returned to participants. The principal reason is that because the tests are being performed for research, therefore the significance for MyMelanoma participants of test results will not be clear until much later. Additionally, due to the scope and size of the study, it would also not be feasible to feedback results with the necessary support for participants. Research groups based in Oxford and the NHS are carrying out projects to devise mechanisms to address this issue and MyMelanoma study could utilise these systems if possible, at a later stage.
The single exception to this will be taken for people taking part in Route to Entry 3, with melanoma in their family. People who are considering participation in this study will be provided before consenting with additional information on what taking part means to them and what MyMelanoma would be able to do if a potentially important finding was made.
The University of Oxford hope to reach their recruitment target for the MyMelanoma study by 30th June 2025.
Benefits reported
Yielded Benefits is not a requirement for new applications.
Register history
When this agreement appeared in, or was edited in, each monthly edition of the register. Built by comparing every edition this site holds.
-
December 2024 —
first listed. 1 version: DARS-NIC-743571-K7X4R-v0.2
-
February 2025
1 version added: DARS-NIC-743571-K7X4R-v1.4
-
June 2026
1 version added: DARS-NIC-743571-K7X4R-v2.3
Cite this page
NHS England (2026) Data Uses Register, September 2026 edition, agreement DARS-NIC-743571-K7X4R, “MyMelanoma Study - NHS DigiTrials Recruitment Service”. Read via NHS Data Access Explorer (unofficial), https://healthdatauses.uk/agreements/dars-nic-743571-k7x4r/ (accessed [date]).
This address stays the same, but the page is rebuilt with each monthly edition, so the citation names the edition it shows. Every edition's data is kept in the facts store.
Source: datausesregister_september2026.xlsx, September 2026 edition of the NHS England Data Uses Register. Search that workbook for DARS-NIC-743571-K7X4R to see the original rows.