MRC Clinical Trials Unit at UCL
2nd Floor
90 High Holborn
London
WC1V 6LJ
Email: mrcctu.stampede@ucl.ac.uk
Participant Information
The participant information section contains information relating to trial participation as well as results summaries developed to communicate results to trial participants and others that may be interested.
Trial Participant Information Sheets
Patient Information Sheets (PIS) describe all of the relevant trial related information in detail. Please see the table below for a breakdown of the different PIS' STAMPEDE has.
STAMPEDE: Patient Information Sheets (PIS) |
|
|
What PIS? |
Content |
|
Overview of why the study is being done and what it involves. Details of study conduct and oversight |
|
|
Treatment Arm-Specific patient information sheet (PIS)
|
Details of treatment associated with each arm of the study |
|
Additional Research Studies Patient Information Sheet (Version 15) |
Details of quality of life study and other optional studies |
Privacy notice for the STAMPEDE trial
Introduction
University College London (UCL) have provided the following privacy notice for patients enrolled into the STAMPEDE trial which aims to test if different ways of treating prostate cancer can improve disease control, reduce relapse and improve life expectancy.
This privacy notice explains who we are, the personal data we collect, how we use it, who we share it with, and your legal rights. This notice is in addition to UCL’s privacy policy (https://www.mrcctu.ucl.ac.uk/privacy/) and applies specifically to personal information held for research purposes in the STAMPEDE trial.
We keep this Privacy Notice under regular review. It was last updated on 18 August 2022.
About MRC CTU at UCL
The trial is run by UCL by the Medical Research Council Clinical Trials Unit at UCL (MRC CTU at UCL). MRC CTU at UCL is one of the UK’s leading centres for clinical trials. Our research helps to improve health care in the UK and around the world, resolving internationally important questions in infections and cancer, and delivering swifter and more effective translation of scientific research into patient benefits. The MRC CTU at UCL obtains appropriate ethical and legal approvals for all trials and studies that it runs. You can find out more about the MRC CTU at UCL here: https://www.mrcctu.ucl.ac.uk/.
The MRC CTU at UCL is part of the UCL’s School of Life and Medical Sciences. UCL is the study sponsor and is the data controller.
Collecting personal information
Personal data, or personal information, means any information about an individual from which that person can be identified. It does not include data where the identity has been removed (anonymous data). Information about your health is a special category of personal data.
To safeguard your rights we will collect the minimal personal information necessary for our STAMPEDE trial. We collect personal information, which includes information about your health and treatment, from the following sources:
- Directly from you with your consent
- From third party sources which routinely collect your health data (such as NHS Digital, other UK NHS bodies, and disease registries) with your consent.
Personal information specifically collected for STAMPEDE trial include hospital admissions, including diagnoses and treatment, and information on cancers and on deaths.
Using your personal information
All of the personal information we collect is only used for the purposes of carrying out our scientific research in the public interest.
UCL is the data controller for processing personal data in the STAMPEDE trial. This means they are responsible for ensuring that the processing of your data complies with the General Data Protection Regulation (GDPR; https://www.gdpr.org) and related legislation. The lawful basis for processing personal information in STAMPEDE trial is GDPR 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,” and Article 9(2)(j) for special category data – “processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes.” We demonstrate that our research serves the interests of society by following the UK Policy Framework for Health and Social Care Research (https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/).
Data linkage
We ask for your consent to collect your NHS number, date of birth and postcode so we can link to your health records in databases held by NHS Digital, other NHS national bodies, Public Health England, Healthcare Quality Improvement Partnership, and cancer registries. The data we receive will provide us information on your long-term health outcomes, such if your cancer gets worse, other cancer diagnoses and the treatment you may receive. Linkage to these databases will enable us to better understand the long-term health issues arising in people who have prostate cancer, and tailor future treatment accordingly. Collecting information in this way should make things easier for the staff at your hospital, allowing them to spend more time on clinical care.
There is more information about the trial in the Patient Information Sheet and Consent Form that you received when you joined the trial. You can also contact the research nurse or doctor at your hospital if you have any questions.
|
Please read this section if you joined the trial before February 2013 There is a group of trial participants for who we do not know if they gave explicit consent for linkage to their health records held by national data providers (such as NHS Digital). Before February 2013, consenting to data linkage was not compulsory when joining STAMPEDE. We now know that five of those participants had refused consent to data linkage. However, we are unable to find out if more people refused consent to linkage when they joined the trial because: 1) older hospital patient records are in storage because their participation in the trial (follow-up) is complete; and 2) some men have moved away from their hospital or have died, so it is not possible to contact them. In 2018, we sent a newsletter to all trial participants via their hospitals to inform them about the collection of their linked health information held by data providers (NHS Digital, Public Health England, and the National Cancer Registration and Analysis Service). We asked for permission from the Health Research Authority’s (HRA) Confidentiality Advisory Group (CAG) to allow us to access linked health records without explicit consent. We also spoke to patients with prostate cancer and the public about accessing linked health records of trial participants without that explicit consent. Each felt it was acceptable because the patients had already agreed to participate in the trial. You can find out more about the Confidentiality Advisory Group from here: https://www.hra.nhs.uk/about-us/committees-and-services/confidentiality-advisory-group/. |
Retention and storage of your data
The CTU stores all personal identifiable data securely, and only authorised trained staff are permitted access. Your NHS number, date of birth, and postcode will be stored in the UCL Data Safe Haven until they are transferred to the data providers (NHS Digital, other NHS national bodies, Public Health England, Healthcare Quality Improvement Partnership, and cancer registries) for linkage with your health records. The UCL Data Safe Haven is known as a Trusted Research Environment – a secure space where sensitive personal data is stored and accessed.
Your NHS number, date of birth, and postcode will only be used by the data providers to link to your health records in their databases so that they can extract the appropriate data for our use. The NHS number and the other personal data used for linkage are removed before the data is sent to us for analysis.
We retain personal information for as long as is necessary to support the research study and its findings, and in line with research retention schedules and regulatory requirements specific for research. For STAMPEDE, your data will be held for 25 years after the end of the study.
We have put in place appropriate security measures to prevent your personal data from being accidentally lost, used or accessed in an unauthorised way, altered or disclosed. We have established procedures to deal with any suspected personal data breach and will notify you and any applicable regulator of a breach where we are legally required to do so.
NHS Digital, other NHS national bodies, Public Health England, Healthcare Quality Improvement Partnership, and cancer registries and UCL (by MRC CTU) will access identifiable information on participants. There will be no access to data by other third parties not listed in this agreement. No individual patients will be directly identified through any published results from the study.
Researchers (under the supervision of UCL) who wish to access the data from this study and/or contact participants about future research will have to apply to the CTU’s Data Access Committee.
Your legal rights
You have rights over your personal information by law. Your usual rights to access, change or move your information are limited because of exceptions applicable to some types of research, and also because we need to manage your information in specific lawful ways in order for the research to be reliable and accurate.
You have the right to request the restriction or suppression of your personal data, so you have the right to withdraw your consent to data linkage at any time. Please talk to your study doctor or nurse who will then inform the STAMPEDE team of your decision. Contact details for members of your study team will be listed within your Patient Information Sheet (PIS). This decision will not affect the care you receive in any way. If you do this, we will use your data up to the point that you say you no longer wish to participate.
If you would like further information or have any concerns about the use of your personal information, please contact our Data Protection Officer by email data-protection@ucl.ac.uk or by writing to University College London, Gower Street, London WC1E 6BT.
STAMPEDE