This section is to provide you with information on how your personal data will be processed in accordance with Data Protection law, when becoming a volunteer with Simbec-Orion Group limited. We remain responsible for the collection and processing of your personal data when you agree to become a volunteer.
Simbec-Orion Group Limited (“Simbec-Orion” or “we”) respects your privacy and rights to control your personal data. To comply with Data Protection Laws, we must tell you how we use any data collected from you and have a lawful reason to hold and store this data. The details we hold related to you may contain your personal data, including so-called ‘special categories’ data (together “data”).
What Are Personal And ‘Special Categories’ Data?
Personal data is any information which can identify you as an individual, whether directly or indirectly. This includes your name, date of birth, address, telephone number, email address, a photo of you and even an identification number.
Special categories of personal data are information about you which reveals your racial or ethnic origin, political opinions, religious or philosophical beliefs or trade union memberships. It also includes genetic information, biometric information, sexual orientation and information regarding your health.
We collect both personal data and special categories of data from you during your registration as a volunteer, the nature of our work requires us select individuals who meet a specific set of characteristics, which changes between each clinical trial we conduct.
Why We Need Your Information?
Becoming a volunteer requires us to collect and process various pieces of information from you to ensure that you can be assessed for each clinical trial that arises. This allows us to not only select suitable individuals for these trials, but also to ensure the health and safety of these volunteers.
Data Used Within A Clinical Trial
During your participation we process a vast amount of personally identifiable and special categories of data, and we take the appropriate measures to make sure the data is not personally identifiable. Where possible we use a Patient ID number instead of your name and record results of clinical trials against the Patient ID for example on an electronic Clinical Records Form (eCRF) and any data stored in a Trial Master file (TMF). This is often accompanied with health or clinical trial related data but without knowing further personal information it is not possible to identify you as an individual, but this data is kept separate regarding the volunteer database and Investigator Site File. Below is the type of data we process, why we need it and our lawful basis.
| Type of Data Collected | Why We collect | Lawful Basis |
| Personal Details. Includes such as Title, Name, Date of Birth, Contact Details, Next of Kin details and National Insurance Number | This information is required to ensure you are recorded and contactable if a suitable clinical trial arises, to process payment to you for participation and contact you pre and post study. We also record some of this information into TOPS Database (see below). Your next of kin details are also required in case of an emergency. | Processing is necessary for the performance of a contract to which the data subject is party or to take steps at the request of the data subject prior to entering a contract. |
| Social Details. Includes questions about whether you’ve had tattoos in the last 3 months and whether you have taken recreational drugs. | This information is required to assist us identify the correct profile of individuals that are required for participation in a clinical trial. This will be determined by the requirements of the clinical trial, but we need to retain this on record, so we can ascertain if you meet the requirements of the clinical trial. | Processing is necessary for the purposes of preventive or occupational medicine. Processing is necessary for reasons of public interest in public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, based on Union or Member State law. |
| Medical Data. Includes accident, medicinal, illness and dental information. Medical Data is also taken during participation in any of the clinical trials, such as blood type/levels/pressure, heart rate, medication and any adverse effects | This information is required so that we can ensure you are suitable for a specific clinical trial and so that we can fully assess your suitability for a clinical trial. We need to retain this information on record, so we can ascertain if you meet the requirements of the clinical trial, where will we then contact you about participation. | Processing is necessary for the purposes of preventive or occupational medicine. Processing is necessary for reasons of public interest in public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, based on Union or Member State law. |
| Females Only. Includes information about whether you are on medication for contraceptives or whether you are sterilised, post-menopausal, or you have had a hysterectomy and the dates for each. In addition to this the dates for Cervical Smear and Mammography are recorded if applicable | This information is required, so that our employees can fully assess your suitability for a specific clinical trial and/or ensure you are cared for appropriately during your time with us. We need to retain this information on record, so we can ascertain if you meet the requirements of the clinical trial, where will we then contact you about participation. | |
| Males Only. Confirmation and date of whether you have had a Vasectomy is recorded | This information is required, so that our employees can fully assess your suitability for a specific clinical trial and/or ensure you are cared for appropriately during your time with us. We need to retain this information on record, so we can ascertain if you meet the requirements of the clinical trial, where will we then contact you about participation. | Processing is necessary for the purposes of preventive or occupational medicine. Processing is necessary for reasons of public interest in public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, based on Union or Member State law. |
| Ethnicity Data. | We need to recruit individuals from different ethnic backgrounds for specific clinical trials. We would be grateful if you could tick the appropriate box that applies to you. | Processing is necessary for the purposes of preventive or occupational medicine. Processing is necessary for reasons of public interest in public health, such as ensuring high standards of quality and safety of health care and of medicinal products or medical devices, based on Union or Member State law. |
| Social and Demographic Data. Includes information recorded against your alcohol, nicotine, caffeine and food intake, and your religious beliefs. | This information is required to assist us identify characteristics of you as a clinical trial participant and present results of clinical trials in a methodical and standardised manner. Please provide detail of any religious beliefs you have which may impact your treatment in the unlikely event of a medical emergency. | |
| Bank Account Details. Such as sort code, account number and account holder. | We process this data to ensure you are paid for your participation in the clinical trial. | Processing is necessary for the performance of a contract to which the data subject is party or to take steps at the request of the data subject prior to entering a contract. |
| Subject ID Number. Is a number we provide that replaces your first and last name. This is to ensure we process the least amount of your personally identifiable data. | To distinguish between volunteers, identify any safety issues in relation to any volunteers, medication administering and to also ensure number of participants can be demonstrated. | The patient ID number is really a control we implement (pseudo reference) to protect your privacy, as opposed to processing personal data. Therefore, processing a patient ID is part of data processes in a clinical trial fall under the same legal basis. |
Data Processed During And After A Clinical Trial
Source data is retained and stored for each trial in line with good clinical practice and clinical trial regulations. In relation to volunteer data, source data will include volunteer data which can be defined as personal and special category data. Source data will be defined in the trial protocol or in a source data location agreement dependent on the trial in which a volunteer can or will participate. Based on the nature of source data defined in line with each and every clinical trial, this data will and can be stored in the volunteer database. For Simbec-Orion to fully evidence that any clinical trial activities have been conducted in line with clinical trial regulation and for necessary reconstruction and evaluation of the trial, source data in the form of certified copies of original records contained in the volunteer database will be retained in an Investigator Site File (ISF).
An Investigator Site File (ISF) is a collection of essential documents maintained at the investigator’s site during a clinical trial. It serves as a central repository for all records required to demonstrate compliance with regulatory guidelines, Good Clinical Practice (GCP), and the clinical trial protocol. The ISF is crucial for ensuring the integrity of the trial and facilitating audits and inspections. Source data, and therefore volunteer data can be retained within an ISF is retained for a minimum of 25 years.
Retaining this data gives a certified copy or snapshot of the source data used and required to confirm you as eligible for participant/subject and therefore enrolled onto a clinical trial. The certified copy of these documents being retained within the trial ISF allows for greater Data Protection compliance and the continued efficiency of conducting activities related to clinical trials at Simbec-Orion.
In addition, during a clinical trial, we may also create what is called a Trial Master File (TMF), which is prepared for the client/sponsor for any given trial. They are provided with the results of the clinical trial, along with medical information, which is presented in a manner that does not identify you as an individual. You will not be able to be identified by the data we provide to a client (your personal data will be ‘pseudonymised’). They require the clinical trial results and supporting documentation and do not require information which directly identifies you.
Details of the processing of data in relation to a particular trial in which you participate will be covered and consented for in the trial specific informed consent form prior to participation.
The Over-Volunteering Prevention System (Tops)
It is vital that you must not participate in too many clinical trials in each time frame. So, to help research units, the Health Research Authority keeps a database, called TOPS. This database contains information relating to healthy volunteers and when they take part in clinical trials.
We will enter only the following information into the TOPS database:
- your National Insurance number (if you’re born in the UK); or
- your passport number and country of origin (if you’re not born in the UK); and
- the date of your last dose of trial medicine.
You will not be identified by name or date of birth and your personal or medical details will not be entered onto this database or shared with other Research units. If you withdraw from a clinical trial before you receive any trial medicine, the database will show that you never received a dose. Only staff at Simbec-Orion and other medicines research units can use the database. We may call other Research units, or they may call us, to check your current and past participation in clinical trials. We subscribe to this database and use it to ensure that high standards of quality and safety are provided to you.
What Will My Personal Data Or Special Categories Of Data Be Used For?
The data, which you have provided by registering into the database, undergoing pre-screening and screening for clinical trials and any other information collected in connection with your visit(s), will be used by Simbec-Orion and Prince Charles Hospital only in the event of an emergency. We will use the information for the purpose of evaluating your eligibility and participation in a current clinical trial or future clinical trials. If your data is passed to PCH they will use your demographic data and religious information to decide on available treatment. We will keep all your data confidential and will not disclose it to third parties except where we are required to do so by law and regulatory guidelines in accordance with the principles of Good Clinical Practice. We will put in place safeguards to protect the confidentiality of your data. Occasionally, we may work with third parties that are in a country which may not have adequate data protection laws in place. In this case, we will ensure that your data is adequately protected by using a series of appropriate safeguards.
How Long Is My Data Kept For?
We only process personal data for as long as required, this could be dictated by a legal requirement, or we may have an appropriate justification to retain certain data in line with clinical trial guidelines.
We will keep your data for a minimum of 2 years. If we have had no contact with you during this time and you have not screened or participated in a clinical trial, we will first reach out to see if you wish to still be part of our database. If you do not respond after 3 attempts your data will be removed from our database. Even if you did complete a clinical trial, your information will be removed from the database, however certified copies of relevant information will be retained in the ISF for the purpose of trial reconstruction and regulatory compliance. If we need to contact you about the clinical trial after you’ve finished it, we might be able to trace you through the remaining information collected and stored in the Investigator Site File. If you have participated in a clinical trial and we have made payments to you, information used for the purpose of processing trial payments (expenses or inconvenience payments) will be retained for 7 years from the point of last payment to align with financial reporting requirements.
Is My Data Shared?
We only share your information with organisations that are approved by us and involved in delivering our services. We use third party providers to help us attract more volunteers. Information completed and submitted online, can be retained, so that they can be contacted for suitable clinical trials. We also have several Contact Associates, who solely represent and are employed by Simbec-Orion. They may contact you to discuss further screening questions, obtain further detail and assist us in obtaining, selecting and screening volunteers for our clinical trials. We may also in an event of emergency share your demographic data and religious data with Prince Charles Hospital.
What If My Data Is Incorrect Or Is Out Of Date?
If you believe that the data, we hold about you is inaccurate in any way, perhaps you have moved home or changed your name (for instance), you should write to us and ask us to correct it. You can contact us at Simbec-Orion Ltd, Simbec House, Merthyr Tydfil Industrial Park, Merthyr Rd, Pentre Bach, Merthyr Tydfil CF48 4DR. We aim to update our records, if appropriate, and get back to you within a month, or you can provide us with the most relevant information at your next screening visit.
Your Personal Data Rights
You have a great deal of rights over your personal information. You have the following rights to your data, irrespective of any trial participation. You have:
- The right to be informed about how your personal information is being used (like this notice!)
- The right to access the personal information we hold about you
- The right to rectify inaccurate or out of date personal information we hold about you
- The right to request that we delete your data, or stop processing it or collecting it, in some circumstances
- The right to stop direct marketing messages.
- The right to request that we transfer or port elements of your data either to you or another provider
- The right to complain to the Supervisory Authority — in the UK, the Information Commissioner’s Office, who can be contacted directly on 0303 123 1113 or you can raise concerns by visiting https://ico.org/concerns
In order to exercise any of these rights please contact Enrolment Services at Simbec-Orion Ltd, Simbec House, Merthyr Tydfil Industrial Park, Merthyr Rd, Pentre Bach, Merthyr Tydfil CF48 4DR. Alternatively, you may content our Data Protection Officers, TechGDPR DPC GmbH, at simbecorion.dpo@techgdpr.com or at TechGDPR, Heinrich-Roller-Straβe 15, 10405 Berlin, Germany.
Can I Withhold Or Withdraw My Consent?
In short, yes. We will not record your data unless you have provided us with your consent to become a healthy volunteer. Registration into our database and participation in any clinical trial is your decision and will only be carried out with your freely given consent. Being a healthy volunteer does not mean that you must take part in any clinical trial. Participation in any clinical trial with Simbec-Orion will only be done with your consent.
You can withdraw your consent at any time and to ask for your records to be removed from our database. This includes withdrawal against medical advice. Medical advice may be given to you to help you make an informed decision, but ultimately, the decision to withdraw will be yours and can be made at any time.
Storing Your Personal And Special Categories Of Data
Becoming a volunteer is your decision. If you wish to be placed on our volunteer database, we will record both personal and special categories of your data. This is so that we can assess if you are suitable to take part in a clinical trial. Simbec-Orion is required to have a lawful reason to process your information as a volunteer and this reason is with your consent.
In addition, we would like to contact you in the future in relation to any clinical trials which we may, at our sole discretion, consider you to be eligible for. If you wish to remain on the database but wish to no longer receive communication regarding trials you may be eligible for, you can choose to opt out of this correspondence:
You can opt-out of this at any time by sending an e-mail to: enrolmentservices@simbecorion.com. You should state your name and email address on such communications and a member of Simbec-Orion’s team will process your request.
Data Protection Consent
By agreeing to this form and selecting the box as outlined on your application, you are confirming that you have read the above information and statement and give your consent for Simbec-Orion to record and retain your personal and special categories of data for the purposes and duration(s) stated above.
I confirm that I have read these terms and understand that Simbec-Orion will be holding and processing my personal and special categories of data for the purposes stated above. Simbec-Orion are also required to process your bio-metric data (a photograph), we do this to ensure we can identify you for security purposes. We do not share this data with any other third-party, we solely use this data for the purpose of recognition. For the completion of your enrolment and part of your eligibility, we are required to collect this data. By selecting the box below, you also explicitly consent to the use of your bio-metric data
