1. What information will be collected, and what will it be used for?

Key message: If you agree to take part in one of our studies, we will need to collect and use some information about you and your health. This is needed to produce the results of the study, to run the study, and to help make sure you and other people taking part in the study are safe.

If you agree to take part in this study, we will need to collect and use some information about you and your health. Some of this information will be used in the study analysis to help find out the results of the study. Other information is needed in order to run the study, make sure you and other people taking part stay safe, and make sure the study results will be reliable. The sections below explain the sorts of information we collect and why we need to do this.

We are able to use your information because we are conducting research in the public interest – this means the research results will be used to improve healthcare for patients in future. This also means we are allowed to use some types of information that have special protection in the law because they are particularly sensitive or private. In our studies, these special types of information can include information about your health, your ethnicity or race, your sex life or sexuality, or genetic information (for example, information about your DNA from biological samples you have given). We will never collect more information than we need for the research, and it will never be possible to identify you in any published research results.

Click on the sections below to find out more.

1.1. Information we need to collect to confirm it is safe and appropriate for you to join a study

If you agree to take part in a study, your study doctor or nurse will send us some information about you through our secure website or an automated phone system. This will contain your date of birth, your initials and some information about your health that will confirm that it is safe and appropriate for you to take part in the study, and that you have given your consent to take part. This information may also contain your NHS or CHI number, usually so that we can check you have not already joined the study. We will keep this information secure, use it to enrol you in the study and give you a unique study identification number that will go with all of your study information. We will then send an automated message by email back to your study doctor or nurse to confirm that you have been enrolled in the study. This message will contain a copy of the information they provided to us, for their records.

Your study doctor or nurse will then post us a copy of your completed consent form, so that we can be sure you have agreed to take part in the study. They will send this separately to other information about you, so that in the unlikely event that it does not reach us, it is not with the other information about you and your health. When the consent form gets to us, we will store it securely, again separately from any other information about you.

1.2. Information from your medical notes for running and analysing the study

Most of the information we collect about you will be from your medical notes, which contain details of all hospital visits and tests you have had. If you agree to take part in one of our studies, your study doctor or nurse will take information from your medical notes about you, about the health condition relevant to the study, and about other aspects of your health, and put it onto our study forms. The information will include results of tests and assessments done for the trial, and also information that was already in your medical notes, such as aspects of your past medical history.

These study forms collect only the information that we need to run and analyse each study, to help make sure that you are safe and to make sure that the study is being run correctly. The forms do not show your name, but only your initials, date of birth and the unique study identification number that we give to each study participant when they join a study. We need all three of these identifying pieces of information to make sure we know the information is about you, and not someone else.

In some studies, your study doctor or nurse will post the completed forms to us at the University of Leeds. When the forms arrive at the University, only specific members of the study team see them. The information on the forms is added to our secure study database, which only the study team can access. The paper forms are securely filed in locked cabinets within the CTRU office.

In other studies, your study doctor or nurse will add the information directly into our secure database. The only people who can access your information are your study doctor or nurse, and people at the CTRU who need access in order to run or analyse the study.

We then do some work to make sure the information is correct. This sometimes means we might need to contact your study doctor or nurse to ask them questions about the information they have given us. Whenever we contact your study doctor or nurse about any aspect of your trial participation, we usually only use your unique study identification number to refer to you. If we ever need to make sure there is no doubt that we are asking about your information (and not someone else’s), we will also use your date of birth and initials.

1.3. Questionnaires we will ask you to complete

Some other information we collect will be on questionnaires that we will ask you to complete. These will ask you about topics relevant to the research. They will only show your unique study identification number, date of birth and initials.

In some studies, we will ask you to complete questionnaires on paper. You may be asked to complete these at your study visits, but your study doctor and nurse will not see your answers when they do not need to. These will be dealt with just like the paper study forms mentioned above. Your study doctor or nurse will post them to us, then we will enter them into our database and securely file them.

In some other studies, we may send you copies of these paper questionnaires in the post so that you can complete them at a time to suit you. We will need to collect your home address in order to do this. When you have completed them, you should post them back to us, taking care to follow the instructions and use the correct address. When we have received them, we will enter your responses into our database and then securely file them.

In other studies, we may ask you to complete questionnaires in a secure online system. We will send you a message by email or text (depending on your preference) when your next questionnaire is ready to complete. We will need to collect your email address or phone number in order to do this. The answers you provide will be saved securely in our database, and only members of the study team who need to run or analyse the study will have access to them.

1.4. Information from your electronic health records for study analyses

As well as the information that your hospital will send to us on the paper study forms or enter into our database, we may also obtain information about you held in NHS databases managed by NHS Digital (https://digital.nhs.uk/) or other providers. To do this, we will securely send some of your information (such as your name, your date of birth or your NHS or CHI number) to the information provider, and they will send back the information about you that we need for the study. The patient information sheet you get when you are considering taking part in a trial will make clear how this works, if this sort of thing is happening in your study.

We do this because it is a more efficient way to collect certain information about your health. By using information collected from routine health visits, we can reduce the amount of time you and your hospital need to give to a study. When we do this, we will only use the information mentioned above to identify you. We will follow strict rules when working with other organisations to maintain confidentiality and protect your information.

NHS Digital and other providers will only provide information to us when they are satisfied that you have agreed to us doing this and that we need your information for research in the public interest. They also need to be satisfied that we will handle all your information securely. When they share your information with us, they can visit us to carry out an audit at any time to check that we are using your information correctly.

You can find out more about the work of NHS Digital at their website: https://digital.nhs.uk/.

1.5. Information relating to your biological samples (for example your blood or urine)

The patient information sheet you get before you agree to join one of our studies will explain which samples you might need to give if you agree to take part.

When studies involve collection of biological samples, the samples will be collected by your hospital team. They will then be sent to study labs, usually just with your unique study identification number, and sometimes also with your initials and date of birth. The labs will analyse the samples, and send the results securely to us so that we can use them in the study analyses. In these studies, the staff at the labs will not be able to identify you from the information they have.

In some studies, the samples may also show your name and NHS or CHI number when they are sent to the labs. These details are needed because the results of the tests will be sent back to your hospital and used in your care, and we need to be absolutely sure that your test results get to you and not to someone else. The labs will also send the test results securely to us so that we can use them in the study analyses.

If you agree to provide samples for future research, these will be sent to a study lab (sometimes called a ‘biobank’) and securely stored with your unique study identification number. In some cases, there may also be other information that may identify you, but you will have been told about this if so. In any case, the staff at the lab will not be able to identify you from the information they have. If other researchers in future request to use the samples for worthwhile research in the public interest, they will be sent the samples but usually without your unique study identification number (a different unique number, created specifically for this purpose, may be used instead). They are likely to need a bit more information about you for their research, to link their analysis of the samples to other information about your health. If they do need this information, they will contact us to request it. See section 5 to find out more about how we share information for future research. These researchers will never be able to see who you are from the information they have, even when they combine the results of analysing your samples with the other information we share with them.

1.6. Information we need to collect to make sure you and others are safe

During and after your time on a study, your hospital will need to inform us urgently if you experience certain serious types of event, such as if you unexpectedly have to go to hospital overnight for any reason. This sort of reporting is required by laws and other rules about research. Your hospital reports this to us on a study form (usually a paper form that is faxed to us) that will show your unique study identification number, initials and date of birth, but nothing else that could identify you.

We will then need to share this information with other organisations. In studies involving medicinal products (for example drugs or chemotherapy), we will need to share the information with regulatory authorities who oversee drug safety (such as the UK regulator, the Medicines and Healthcare products Regulatory Agency, or MHRA) and with the company that makes the medicine, so that they have up-to-date information about how safe the medicine is. In all studies, we have to share this information with the Research Ethics Committee that has approved the research. We sometimes also need to share the information with the other healthcare centres taking part in a study. No one in these organisations will be able to identify you from the information we share with them. See section 5 for more about how we share this information.

In some of our studies, your study doctor and nurse will not know what treatment you are receiving. This is so that their decisions and behaviour are not influenced by their knowledge of your treatment. This sort of study is called a ‘blinded’ study, and can have more reliable results than studies that are not blinded. The patient information sheet about a study will make clear if your study is a blinded study. In the unlikely event of a medical emergency happening while you are on a blinded study, your study doctor and nurse might need to urgently find out what treatment you have had. They can do this by providing your unique study identification number either to a specific team at the University of Leeds, or through a service provided by another organisation. Your study doctor or nurse will then instantly receive the details of your treatment. No other information about you will be used in this process.

1.7. Other types of information

Various other kinds of information may be needed for our studies. The patient information sheet about a study will make clear if these apply, or you can ask your study doctor or nurse if you are not sure.

  • In some studies, we might need to ask doctors who work with us to give advice on specific situations, or check the information that your study doctor or nurse have provided to us on the study forms. To do this, we might need to collect copies or scans of parts of your medical notes. If this is needed, we will ask your study doctor or nurse to remove all information that could identify you, and just add your unique study identification number before sending it to us (or sometimes also your initials and date of birth if we need to be absolutely certain that the information is your information).
  • In some studies, it is particularly important that we check the study processes are being followed, or check that study measurements are being taken correctly. To do this, we will need to collect videos, sound recordings or photographs of parts of your body, or of surgery or other medical procedures you have done. Your study doctor or nurse or someone working with them will usually be the person to make the recording or take the photograph. They will then remove any identifiable details and just add your unique study identification number (or sometimes also your initials and date of birth if we need to be absolutely certain that the information is your information). They will then send them securely to us, usually by a very secure internet transfer system. We will make sure they are securely stored, separately from any information that could directly identify you. We will then share the recordings with authorised doctors who are reviewing them on our behalf (see section 5 for more information on this). If this applies to a study you are taking part in, or considering taking part in, the details will be in the study patient information sheet.
  • In some studies involving radiotherapy, we need to check that the radiotherapy is given in the same way to different people at different hospitals. To help us check this, some information about your radiotherapy and other medical information may be sent to a specialised team at a hospital in the UK. Any information that can identify you (such as your name) will be removed before it is sent to them. The team at the hospital will carry out a review of the radiotherapy information, and send the results of this review securely back to your study doctor. In some cases, we may also receive a copy of the results, but without any information that could identify you. This network of specialists around the UK is called Radiotherapy Trials Quality Assurance (RTTQA) and you can find out more about them on their website: http://rttrialsqa.org.uk/rttqa/.
  • In some studies, we need to check that study measurements have been done correctly. To do this, we will need to collect images from medical imaging such as X-rays, MRI scans or CT scans. We will make sure that any information that could identify you is removed from the scans before they are sent to us. Instead, they will just show your unique study identification number (or sometimes also your initials and date of birth if we need to be absolutely certain that the information is your information). The scans will be sent to us securely, and we will store them securely, separately from any information that could directly identify you and accessible only by people who need to run and analyse the study. We will then share the recordings with authorised doctors who review them on our behalf (see section 5 for more information on this).
  • In some studies, we will collect your postal address, email address, phone number or other contact details so that we can send you things such as study questionnaires, reminders to complete study questionnaires, thank you cards when you have completed the study, or the results of the study when they are available. We may also need to collect your address in studies where we deliver study treatment (bottles of pills, for example) directly to your home. You can usually choose which details to provide. We will ask you to add them to a contact details form, which your study doctor or nurse will then post to us, separately from other information about you. Once we receive this form, we will store it securely and separate from other information about you. We will enter your details into a secure database separate from any of your medical information. We will only use your contact details for the purposes specified in the study patient information sheet.
  • In some studies, we will be able to reimburse you for extra travel you might need to do, or for any other costs. If this is relevant to you, it will be made clear to you in the study patient information sheet. In order to reimburse you for the costs, we need to collect your bank details. We will ask you to provide these on a specific form, and post the form back to us, taking care to use the right address. We will pass the bank details and some identifiable information (including your name) to the University of Leeds Finance department, who will use them to process the payments you are owed. We will store your details securely, separately from any other information about you. The Finance department will keep your details as long as needed, in line with University of Leeds policies on data retention (find at more at this website: https://dataprotection.leeds.ac.uk/)
  • There may be other types of information about you needed for a certain study. If this is the case, it will be made clear to you in the patient information sheet before you agree to take part.