If you are invited to take part in a study with SHORE-C you will be asked to complete a study consent form. This is composed of a number of study specific statements accompanied by a box to be initialled/ticked to confirm your agreement and/or consent to each statement. It also contains one or more statements enabling you to confirm that you understand the reason why SHORE-C will hold your data and if applicable, your agreement for SHORE-C to hold your name and contact details for the purpose of collecting patient reported data. You will be asked to confirm that you have read and understood any participant information documents. Where data are collected at more than one time point for SHORE-C led research, you will be asked to confirm that you are happy to continue in the study at each time point. You may also be invited to give permission for anonymised interview quotes or photographs to be used for illustrative purposes.

Where is your data stored?

Research data

SHORE-C investigator led research involves the collection and storage of patient reported outcome (PRO) and other data. In addition, SHORE-C undertakes collection of PRO data for other clinical research studies sponsored and managed by external academic or pharmaceutical organisations. Data collected are the responses to paper or online questionnaires, free text generated during an interview, or audio recordings or transcripts.

Personal data

We may ask for your consent to hold your name and contact details and other study data classed as personal. Contact data (home address, email address, telephone number) will be used for the purposes of sending questionnaires, or other study related documents to you and to enable us to conduct telephone interviews or call you for any study related queries. We will also hold contact information for people attending our communication workshops for the purpose of sending out information about the workshop, confirming bookings and if agreed sending out information about future events that may be of interest.


Data sharing

Data collected for SHORE-C led studies may be transferred to an external statistician for analysis. SHORE-C will provide anonymised data in the format required by the statistician and will work with the statistician to resolve data queries and undertake any further data cleaning required. Data collected by SHORE-C for externally sponsored and managed studies will be transferred according to protocol and according to any other arrangements e.g. for trials reports or as stated in a contract. SHORE-C will provide data in the format requested and will provide assistance to resolve data queries and undertake any further data cleaning required.

Any requests for data collected and held by SHORE-C must be made in writing. This includes requests from members of study oversight committees, including the chief investigator, where the proposed use of the data does not form part of the protocol analysis or study contract. SHORE-C deposits some study data into the University of Sussex data repository (Figshare).

Withdrawal from studies?

Your participation in our studies is voluntary and at any time during a study, you have a right to withdraw consent. Unless otherwise stated in the study information and the consent form you sign, we will only use any study data collected up until the time you withdraw and will destroy any personal details that we hold (i.e. name and contact details).

Research data lifecycle

  • If you agree to take part in one of our SHORE-C studies, you will be asked to sign a consent form. If we are collecting quality of life data as part of a large clinical trial conducted elsewhere, the consent form will contain a section pertaining to quality of life. We may ask for your consent to hold your name and contact details and other study data classed as personal.
  • When taking part in a study, you will be allocated a study number, which will be used as a code to identify you on all your study data (including study forms, questionnaires, and interview data). The reason for collecting your study data will depend upon the study design and will be explained in your participant information leaflet.
  • Your personal details will not be passed to anyone outside the study research team. The study research team may include persons working on the study at other locations, such as the hospital where you are being treated and the clinical trials unit conducting the study.
  • Any study data held electronically on a database will be identified using your study code only. We may periodically transfer these data to other members of the research team for the preparation of trial progress reports and analyses. It will not be possible to identify you on the data files sent from SHORE-C.
  • At the end of a study, your study data may be transferred to another research unit for statistical analysis and publication of the study results, but it will not be possible to identify you in the data files transferred.
  • Authorised persons from the UK Regulatory Authority (the Medicines and Healthcare Products Regulatory Authority) or the study Sponsor (the organisation responsible for the overall conduct of the study) may require access to your study data as part of a clinical trials regulatory inspection. These inspections are conducted to ensure that studies are carried out to the highest possible scientific standards. All will have a duty of confidentiality to you as a research participant.
  • At the end of your participation in a study we will destroy any contact details held at SHORE-C unless you have been offered the option to receive a copy of the published study results, in which case we will hold your details until we have sent them to you. Only your name will be kept on your consent form, held separately from study data, and destroyed at the end of the archiving period.
  • Any study data (and signed consent forms) held at SHORE-C following study closure, will be archived for at least five years, according to applicable regulatory requirements (Good Clinical Practice, MHRA Clinical Trials Guidance). It will not be possible to identify you from the data held. At the end of the archiving period, arrangements for confidential destruction will be made. SHORE-C will archive SHORE-C owned data. Arrangements for archiving data collected for externally sponsored and managed studies will be determined during study design and may be written into a protocol or contract.