SYMPLIFY Trial Communications via NHS DigiTrials

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Objective for processing

The University of Oxford and GRAIL Bio UK Ltd, as joint data controllers, are requesting a mailout via the NHS DigiTrials communications service. This mailout will be sent to a consented cohort of participants who have been recruited to SYMPLIFY, a study designed to assess GRAIL’s Galleri®(Trademarked) multi-cancer early detection (MCED) test in individuals referred with signs and symptoms of cancer. The University of Oxford and GRAIL Bio UK Ltd require access to NHS England Data for the purpose of the SYMPLIFY clinical trial. Note that all members of the team running the trial are based at the Oncology Clinical Trials Office (OCTO) and Primary Care & Vaccine Collaborative Clinical Trials Unit at University of Oxford (UoO). For the sake of consistency, and as UoO is listed as a data controller, when referring to UoO throughout the application, this encompasses the team at OCTO and Primary Care & Vaccine Collaborative Clinical Trials Unit. The following is a summary of the aims of the clinical trial provided on behalf of the University of Oxford and GRAIL Bio UK Ltd, that this Data Sharing Agreement is intended to facilitate: Background, Purpose and Rationale behind SYMPLIFY: SYMPLIFY is a multi-centre, observational trial with prospective collection and retrospective analysis of blood samples, with the primary aim to evaluate the performance of a multi-cancer early detection (MCED) test within the NHS in England and Wales. SYMPLIFY is a multi-centre, observational study with prospective collection and retrospective analysis of blood samples to evaluate the performance of a multi-cancer early detection test within the NHS in England and Wales. The study enrolled almost 6,000 participants between July and November 2021. Recruitment completed on 30 November 2021 with a total of 6,240 participants. Individuals consented are over the age of 18 years, willing and able to give informed consent for participation in the study, and referred to a Rapid Diagnostic Centre for non-specific cancer symptoms or a gynaecological, lung, upper gastrointestinal, or lower gastrointestinal urgent “2-week-wait” (2WW) cancer referral pathway. Participants were consented voluntarily and participants could choose to withdraw their consent at any point during the study. GRAIL’s Galleri®(Trademarked) MCED test can detect many types of cancer from a single blood sample. The test is called Galleri®™ and this trial aims to find out whether it is better at discovering cancer early, compared to other tests that the NHS currently uses. The Primary objective of the study is to evaluate the performance of a GRAIL’s Galleri® MCED test for the detection of invasive cancer. Although a test result of "cancer signal detected" may indicate the presence of cancer, further investigations to diagnose cancer are necessary in accordance with professional guidelines. As the test requires clinical validation, no individual results are returned to SYMPLIFY participants or the clinicians responsible for their care. The Secondary objectives of the study are to evaluate the: Individuals were recruited to the trial between July and November 2021, and referred to a Rapid Diagnostic Centre for non-specific cancer symptoms or a gynaecological, lung, upper gastrointestinal, or lower gastrointestinal urgent “2-week-wait” (2WW) cancer referral pathway. - Performance and yield of the MCED test by referral pathway(i.e. lung, upper Gastrointestinal (GI), lower GI, gynae, and Rapid Diagnostic Centres (RDC)) and cancer type and stage; A new exploratory objective for 2024 is to investigate cancers diagnosed within 2 years of being recruited into SYMPLIFY. This will allow the SYMPLIFY trial to check if there are any future diagnoses that may help assess the long-term accuracy of the GalleriTM test by re-examining the entire cohort in order to see if participants for whom a cancer diagnosis was not identified during the SYMPLIFY trial were then identified to have a cancer diagnosed in the cancer registry within 2 year of being recruited. - performance of the MCED test for the identification of cancer signal origin (CSO) by referral pathway. SYMPLIFY participants originally only consented to a 12 month follow-up period where the University of Oxford and GRAIL Bio UK Ltd could investigate any cancers diagnosed by the NHS. This Data Sharing Agreement is therefore a request for a mailout via the NHS DigiTrials Communications Service. The mailout will advise SYMPLIFY participants that the trial now wishes to review their medical records covering a period of 24 months from the date of their recruitment. The Exploratory objectives of the study are to: The following NHS England Data will be accessed: - evaluate the completeness of patient data collected from central databases locally within 3 months and by 9 months of enrolment, and centrally monthly from 3 through 12 months post enrolment • Personal Demographics Service – necessary for the purposes of providing key information to the third party mailing provider who have been contracted to contact participants on behalf of the trial. - estimate if clinical parameters further optimise the performance of MCED test, resource utilisation, the time to diagnostic resolution. and yield of non-cancer diagnoses by referral pathway at 12 months post enrolment The level of the Data will be identifiable – necessary because the third party mailing provider requires enough information to be able to contact potential participants. The Trial Management Group (TMG) will be responsible for day to day conduct of the study. The TMG consists of the Chief (Chair) and Lead Investigators, Trials Unit representatives, a University of Oxford representative and representatives from GRAIL. The study will be overseen by the relevant oversight committees of the two trials units involved, taking into account input from the GRAIL Clinical Advisory Group. The Data will be minimised as follows: GRAIL’s Galleri®(Trademarked) MCED test • Limited to individuals (<6,240 adults) who consented to be part of the SYMPLIFY trial A new Multi-Cancer Early Detection (MCED) test has been developed that can detect many types of cancer from a single blood sample. This test is called Galleri®™ and this trial aims to find out whether it is better at discovering cancer early, compared to other tests that the NHS currently uses. GRAIL's Galleri®™ MCED blood test is a qualitative, next-generation sequencing (NGS)-based screening test using cell-free DNA isolated from adult human peripheral whole blood. When a cancer signal is detected, the test can also localise the cancer signal with high accuracy. The test report describes one or two Cancer Signal Origins (CSOs). If the first CSO score is high (≥9.0), then only one CSOs is reported, otherwise the two top CSOs are reported. MCED has 21 possible CSOs: anus; bladder; urothelial tract; bone and soft tissue; breast; cervix; colon, rectum; head and neck; kidney; liver/bile duct; lung; lymphoid lineage; melanocytic lineage; myeloid lineage; neuroendocrine; ovary; pancreas, gallbladder; plasma cell lineage; prostate; stomach, oesophagus; thyroid gland; uterus. It is designed as a screening test and not to confirm a cancer diagnosis. Although the test result of "cancer signal detected" with Cancer Signal Origin may indicate the presence of cancer, further investigations to diagnose cancer are necessary in accordance with professional guidelines. As the test requires clinical validation, no individual results will be returned to the study participants or the clinicians responsible for their care. • Limited to only the identifiable information necessary for the purposes of sending a tailored letter to participants Patient and Public Involvement and Engagement (PPI&E) The University of Oxford are the research sponsor. Both the University of Oxford and GRAIL Bio UK Ltd are the controllers as the organisations responsible for ensuring that the Data will only be processed for the purpose described above. Ongoing PPI&E is conducted throughout the trial. Historical PPI&E was conducted to develop the participant facing materials and on questionnaires, and including specific questions to PPI groups around the sharing of pseudonymised data with GRAIL, LLC. Ongoing PPI&E includes, for example, PPI&E on new participant facing materials, survey feedback on the participant experience, and questionnaires for follow-up of participants. The University of Oxford’s lawful basis for processing personal data under the UK GDPR is: Transparency / Communication with Participants: 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 Health Research Authority (HRA) details in their Research Transparency Strategy that ‘Informing Participants’ is one of the four elements of research transparency, stating that it is a good practice requirement that people who have taken part in a research project are thanked for their contribution and told about what it helped the researchers to find out, where appropriate. Furthermore, the UK Policy Framework for Health and Social Care Research states in PRINCIPLE 11: Accessible Findings: “where appropriate, information about the findings of the research is available, in a suitable format and timely manner, to those who took part in it, unless otherwise justified." To this end, the SYMPLIFY team are looking to send an update(s) to participants to make them aware of the trial results to which they have contributed. This agreement is therefore being put in place with NHS Digital to facilitate this. GRAIL Bio UK Ltd’s lawful basis for processing personal data under the UK GDPR is: The SYMPLIFY team will also be using this mailing to remind its study participants of the plan to share pseudonymised record level trial data with GRAIL, LLC in the USA, who are joint Data Processors in the active agreement (currently v1.2) for outcomes data for the SYMPLIFY study (DARS-NIC-604851-W0M3S). This flow of data was always the intention of the study, and was stated in the consent form and patient information sheets at the time of patients consenting to the trial. However, it was advised by NHS Digital that - at the time - suitable transparency materials on the website did not clarify the flow of data, and this mailout will ensure participants are aware of the flow. The mailout provides participants with a reminder of this data flow and a 4 week period in which to withdraw from the study if desired. Article 6(1)(f) - processing is necessary for the purposes of the legitimate interests pursued by the controller. Organisations involved in this agreement, and their roles: GRAIL Bio UK has determined that the processing is necessary for its legitimate interests, specifically for conducting scientific research in the detection of cancer through the SYMPLIFY Study. The study seeks to understand how well the MCED test works, improve early cancer diagnosis, and potentially integrate this test into clinical practice. The research aligns with NHS England's goal of increasing early-stage cancer diagnosis, thereby providing significant public health benefits. • GRAIL Bio UK Ltd are a joint Data Controller for this agreement, who also process the data. They are responsible for sponsoring and funding the trial, as well as the building and maintenance of the Clinical Records Management System. The University of Oxford and GRAIL Bio UK Ltd’s lawful basis for processing special category data under the UK GDPR is: • University of Oxford are a joint Data Controller who also process the data and are responsible for implementing the trial and for primary objective analysis. 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. • GRAIL, Limited Liability Company (LLC). are the manufacturers of the MCED test, Galleri (Registered Trademark), and have set up the above UK subsidiary, GRAIL Bio UK Ltd, which is the sponsor of the NHS-Galleri trial. GRAIL, LLC will be receiving pseudonymised record-level NHS Digital data from King’s College London, and are therefore listed as a Data Processor in this agreement. This processing is in the public interest because the results of the study may help improve early diagnoses rates of cancer within the UK. More treatment options are available when cancer is detected earlier and outcomes are typically better. • NHS Digital are acting as a data processor on behalf of GRAIL Bio UK Ltd and University of Oxford and are responsible for running the cohort of participants via a vital status check as part of the NHS DigiTrials communications service. All individuals receiving communications under this Data Sharing Agreement have consented to be part of the SYMPLIFY trial. It is within their reasonable expectations to be kept informed regarding any planned changes to the trial. • PSL Print Management Ltd (formerly Print Search Lancashire) are acting as a data processor on behalf of NHS Digital and are responsible for maintaining a service contract with NHS Digital and managing the mailout performed by Datagraphic Ltd. PSL Print Management Ltd will not receive, store or have access to NHS Digital record level data under this agreement. * The funding is provided by GRAIL Bio UK Ltd. • Datagraphic Ltd NHS England are acting as a data processor Processor on behalf of NHS Digital the University of Oxford and PSL Print Management Ltd GRAIL Bio UK Ltd, and are responsible for receiving the list of updated cohort participants from NHS Digital and mailing out to them accordingly. * for: * 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 Digital maintains a service contract with PSL Print Management Ltd, and Datagraphic Ltd, in turn, are contracted to PSL, therefore both organisations are considered Data Processors on this agreement. 1. Processing the cohort supplied to NHS England by the trial and checking the details against the Personal Demographics Service for the purpose of validating postal address details; and checking whether any cohort members have died The SYMPLIFY study is funded by an unrestricted educational grant from GRAIL Bio UK Ltd and supported by NHS England, NHS Wales, the National Institute for Health Research (NIHR) and the Oxford NIHR Biomedical Research Centre. NHS England, NHS Wales and the NIHR will not have access to record-level NHS Digital data, and they do not in any way decide the purpose of the study, how it is run, or the means of data processing, nor have any access to record-level NHS Digital data. NHS Digital therefore do not consider them to be a Data Controllers. 2. Sending the cohort information to the third-party provider (Datagraphic Ltd) for generating the letters to be sent to the living participants GDPR Legal Basis for the Processing of Personal Data: 3. Agreeing with the University of Oxford and GRAIL Bio UK Ltd’s key processing timelines University of Oxford, as joint Data Controller, are using Article 6:1(e): Specific task in the ‘public interest’ or task that has a clear basis in law. 4. Overseeing performance of Datagraphic Ltd and alerting performance issues to the University of Oxford and GRAIL Bio UK Ltd. GRAIL Bio UK Ltd, as a joint Data Controller, are using Article 6(1)(f) "processing is necessary for the purposes of the legitimate interests pursued by the controller or by a third party except where such interests are overridden by the interests or fundamental rights and freedoms of the data subject which require protection of personal data, in particular where the data subject is a child." Processing personal data is necessary for GRAIL Bio UK Ltd’s legitimate interests which are described in this application. The data to which access is requested are proportionate and necessary to achieve those interests. GRAIL Bio UK Ltd have completed a legitimate interests assessment (LIA) and are satisfied that the interests of the data subjects do not override their legitimate interests; that they would reasonably expect the processing and it would not cause unjustified harm. The data subjects interests and fundamental rights are protected through appropriate minimisation of fields and patient records being processed; protection of the data in a secure environment, and guaranteeing secure destruction at any stage at the request of NHS Digital or after a defined period on completion of the project. NHS Digital have compared this LIA against the ICO’s checklist (https://ico.org.uk/for-organisations/guide-to-the-general-data-protection-regulation-gdpr/lawful-basis-for-processing/legitimate-interests/) and are content that all requirements are met. 5. Feeding back to the University of Oxford and GRAIL Bio UK Ltd performance in relation to Key Performance Indicators (KPIs) of Datagraphic Ltd and NHS England. Additionally (as health data is a special category of Personal Data), both University of Oxford and GRAIL Bio UK Ltd are using Article 9:2(j): Special category data used for “Archiving in the public interest, scientific or historical research or statistical purposes”, with a basis in law. 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 Agreement. In the future, GRAIL Bio UK Ltd may receive commercial benefit (including intangible or indirect commercial benefits such as positive publicity) from the successful outcomes of the trial. GRAIL Bio UK Ltd and the NHS have entered into a partnership whereby the Galleri®™ test will be piloted in clinical trials within the NHS in England. If the test is shown to work as intended in these clinical trials, the NHS may purchase the test from GRAIL and make the test routinely available in the future to benefit patients. 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. Access to confidential patient identifiable data is restricted to employees or agents of Datagraphic Ltd using devices owned by Datagraphic Ltd. PSL Print Management Ltd 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 Data under this DSA. A Public and Patient Involvement and Engagement group were consulted on: - What they thought about the SYMPLIFY trial asking to collect data for longer than they originally planned to - Whether they expected to be contacted to consent again, or would be happy to be given the option to opt-out - How they would react to being contacted again No objections were raised by the group to the principle of collecting data for an additional year, especially in the context of no additional burden being placed on participants by data linkage. All were happy with the opt-out option rather than being asked to re-consent. The letter to participants informing them of plan to continue collecting data and giving an option to opt out was discussed extensively. While the group agreed a letter was essential, they emphasised the need to be sensitive towards participants. GRAIL Bio UK Ltd may receive commercial benefit (including intangible or indirect commercial benefits such as positive publicity) from the successful outcomes of the trial. GRAIL Bio UK Ltd and the NHS have entered into a partnership whereby the Galleri®™ test will be piloted in clinical trials within the NHS in England. If the test is shown to work as intended in these clinical trials, the NHS may purchase the test from GRAIL and make the test routinely available in the future to benefit patients.

Processing activities

All organisations party to this agreement must 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 i.e: employees, agents and contractors of the Data Recipient who may have access to that data). The University of Oxford will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Sex and a unique person ID) for the consented SYMPLIFY trial participants. The University of Oxford will not supply the details of any participants who are known to have withdrawn consent for all forms of follow-up. Proposed Methodology:: NHS England will process the supplied participant list and check the details against the Personal Demographics Service for the purpose of validating postal address details; and checking whether any cohort members have died. >Cohort: NHS England will provide the relevant records of the living participants from the Personal Demographics Service dataset to Datagraphic Ltd. The Data will contain directly identifying data items including: Title, First Name, Surname, and Full Address including Postcode which are required for the purposes of contacting participants. 1. GRAIL Bio UK Ltd will create a list of participant Study IDs (excluding anyone GRAIL Bio UK Ltd knows to have withdrawn consent for all forms of follow-up), NHS Number and Date of Birth and provide this securely to NHS Digital using Secure Electronic File Transfer (SEFT) Datagraphic Ltd will use template letters designed by the University of Oxford to contact the participants. The content of the communication will be checked by NHS England to ensure that it aligns with the purposes outlined within this Data Sharing Agreement. 2. The cohort is validated using an automated pipeline to check for errors. The letters will provide information about how to opt-out of further use of their data in the trial. Any participants who have opted out will be removed from the list of participants held by the trial and by NHS England, in relation to the activity specified. 3a. If the file has more than 2% errors, the file is sent back from NHS Digital to GRAIL Bio UK via SEFT to be reviewed and corrected. Where letters are returned to sender, Datagraphic Ltd will generate a report for NHS England specifying any individuals who were non-contactable. 3b. If the file has less than 2% errors, this will be accepted by NHS Digital and processed using an automated pipeline to check for vital status and addresses. The Data will not be transferred to any other location. Datagraphic Ltd will contact individuals as specified by the University of Oxford and GRAIL Bio UK Ltd. All participants will receive a letter containing their Forename, Surname, and full Address including Postcode. >Vital Status Check The Data will be stored on servers at Datagraphic Ltd. NHS Digital will perform a vital status check and remove any additional participants known to have died (whom GRAIL Bio UK Ltd may not have been aware of due to the intermittent nature of the vital status update that SYMPLIFY receives). The Data will be accessed onsite at the premises of Datagraphic Ltd, or by authorised personnel via remote access. >Data Out The Controllers must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract. After performing the vital status check, NHS Digital will then retrieve the latest address and postcode for the remaining participants: For remote access: • A file containing participant's Title, Forename, Surname, Address and Postcode will be sent to NHS Digital's third party mail house, Datagraphic Ltd from NHS Digital via SEFT. - Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA; • Datagraphic Ltd will then mail out to individuals using an ethically approved letter provided by GRAIL Bio UK Ltd. - Access controls granting users the minimum level of access required are in place; • All participants will receive a letter containing their Title, Name, Address and Postcode. - Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data; • Datagraphic Ltd will destroy all data received from NHS Digital within 20 working days after mailing as instructed by NHS Digital. - Multifactor authentication (MFA) is required for remote access; NOTE: For this agreement, no data will be returned to GRAIL Bio UK Ltd. GRAIL Bio UK Ltd do not store participant address details for the SYMPLIFY study therefore do not require for these to be returned. GRAIL Bio UK Ltd obtain outcomes data (including Civil Registration - Deaths data) via a separate agreement (DARS-NIC-604851-W0M3S) and therefore do not require vital status information to be returned under this agreement. - Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access; > Return to sender and follow up queries - All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy. The letter will provide details for how to contact the SYMPLIFY team at University of Oxford for follow up enquiries. A 'return to sender' address will need to be included on the letters, which will be Datagraphic Ltd. When the returned item is received, Datagraphic Ltd will carry out an automatic reconciliation using a 2D Mailcare barcode contained within the address window, which identifies the mail date and originating client. The unopened letter will be scanned, and the return recorded. The database is updated with a ‘reason code’ for the undelivered mail items, alongside the original address fields, and the piece of mail is then securely destroyed. The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose). >Opt Outs Processing will be from secure locations within England and Wales. The Data will not leave England and Wales at any time. The mailing(s) will include information for participants on how to opt out of SYMPLIFY should they wish. This information will also be on the trial website and included in the privacy notice. Participants will be able to write or e-mail their intention to the SYMPLIFY team at University of Oxford who will update their records accordingly. Access is restricted to employees agents of NHS England and Datagraphic Ltd only. Any such participants would be removed from the list of participant IDs that GRAIL Bio UK Ltd send to NHS Digital for any subsequent mailing(s) (along with those who have died, withdrawn consent for follow-up or elected to receive communications electronically). v Grail Bio UK Ltd, GRAIL LLC and PSL Print Management Ltd are not permitted to access the Data. All personnel accessing the Data have been appropriately trained in data protection and confidentiality. The Data will not be linked with any other data. Datagraphic Ltd will destroy all Data received from NHS England within 30 days, and no less than 10 days after contacting the participants, as instructed by NHS England. If there are any errors with the communication, NHS England can request a legal hold – preventing destruction of the data file – until there is a resolution.

Expected output

The key immediate expected output of this Agreement will be a mailing communication delivered to the participants of the SYMPLIFY trial. trial programme in Q4 2024. The ultimate output of this data processing will be participants being mailed a letter to inform them of an update to the SYMPLIFY trial and to remind them of the flow of data being sent to the USA. No other outputs are expected (such as results, presentations or reports) as a result of this Data Sharing Agreement. The SYMPLIFY trial has a separate data sharing agreement (DARS-NIC-604851-W0M3S) for outcomes data relating to the study, which should generate outputs such as results, presentations or reports. The communication will provide information which explains that an additional year of follow-up data is required; how participants can opt-out of this further processing; and the results from analysis already published by the SYMPLIFY trial to date. No other outputs are expected as a result of this Data Sharing Agreement (e.g. results, presentations or reports). The communications delivered will facilitate further outputs to be delivered under Data Sharing Agreement DARS-NIC-604851-W0M3S. DARS-NIC-604851-W0M3S will request an additional 12 months of Cancer Registration data for SYMPLIFY trial participants who have not opted out of further processing, from which further trial outcomes can be addressed.

Expected measurable benefits

Keeping participants informed of results of trials they are involved with is a high priority according to the Health Research Authority and is best practice. The communications will also provide an opportunity to inform participants regarding the planned sharing of data with USA so ensure transparency. This communication will enable the trial to request further health outcome information on their participants under DARS-NIC-604851-W0M3S. DARS-NIC-604851-W0M3S hopes to investigate cancers diagnosed by the NHS in accordance with professional guidelines, within 2 years of a false positive multi-cancer early detection result. This, in turn, is intended to add to the body of evidence which will inform better care and treatment decisions for individuals affected by cancer. GRAIL Bio UK Ltd and University of Oxford hope that by communicating with participants via this mailout, that they will help to keep them engaged with the work of SYMPLIFY and make it clear that participants are partners in the research. Keepings participants informed is hoped to create a positive individual experience for the participant, knowing that their contributions have helped to inform the best possible experience and outcomes for individuals affected by cancer. This is turn may encourage sign up to research in future. The letters will Keeping participants informed on the use of their data is also intended to provide them with an opportunity to remind participants that information about how express their data are handled is available on the trial website. wishes regarding continued participation. There is evidence that good communication helps to build trusting relationships between patients and health professionals, leads to greater satisfaction for both groups, helps people to take more responsibility for their own health and reduces medical errors and mishaps. Maintaining effective communication with participants is also expected to benefit the reputation of the organisations running the trial, which is turn is hoped to increase their ability to connect with broader participant communities for future research.

Benefits reported

Yielded Benefits is not a requirement for new applications. DARS-NIC-661736-Y2Q9R-v0 enabled the SYMPLIFY trial to communicate details of a planned transfer of participant data to GRAIL LLC in the United States of America. The SYMPLIFY trial did not receive any objections to this communication. The communication enabled GRAIL LLC to complete analysis of their multi-cancer early detection test under DARS-NIC-604851-W0M3S.