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

 

Who should read it?

 

General Patient Information Sheet - Part 1 & 2 (Version 20)

 

Overview of why the study is being done and what it involves.

Details of study conduct and oversight

 

Everyone interested in taking part

Treatment Arm-Specific patient information sheet (PIS)

Arm A (Version 14)

Arm K (Version 5)

Arm L (Version 5)

 

 

Details of treatment associated with each arm of the study

 

Everyone allocated to the specific treatment

 

 

Additional Research Studies Patient Information Sheet (Version 15)

 

Details of quality of life study and other optional studies

 

Everyone interested in taking part

 

Privacy notice for the STAMPEDE trial

Introduction

 

The Medical Research Council Clinical Trials Unit at University College London (MRC CTU at UCL) has invited you to participate in 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.ctu.mrc.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 09 March 2021.

About MRC CTU at UCL

 

The 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 here: https://www.ctu.mrc.ac.uk/.

The MRC CTU is part of the School of Life and Medical Sciences at UCL, and is running the STAMPEDE trial. 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:

  1. Directly from you with your consent
  2. 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 will ask for your consent to collect your NHS number, date of birth, and postcode to 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 as cancer progression, new cancers 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.

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.

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

Systemic Therapy in Advancing or Metastatic Prostate cancer: Evaluation of Drug Efficacy

See the latest News in STAMPEDE through the link to the right.