INFORMATION SHEET
Title of Project: The burden of inflammatory bowel disease (IBD) to society (the "Survey").
Purpose of the Survey
Inflammatory bowel disease (IBD - including both Crohn’s Disease and Ulcerative Colitis) is poorly understood by the general public. Even when people recognise the name of the disease, they rarely appreciate its severity and potential lifelong implications for patients and their families. This survey will evaluate the impact IBD has on sufferers and the results will be included in a ‘White Paper’ which is currently in development. The purpose of this White Paper is to present evidence demonstrating the impact of the disease on patients with comparisons being made with both other chronic diseases and with patients suffering from IBD in other countries. The ambition of the authors is that by making comparisons between patients across different countries, they will be able to identify whether outcomes vary between countries and potentially highlight lessons which could be learned from other countries about the care and treatment of patients with IBD.
The survey results will be shared with Crohns and Colitis UK.
The White Paper is being developed by Boston Consulting Group AG and is being sponsored by Takeda Pharmaceuticals International AG. As a pharmaceutical company committed to improving the health and wellbeing of patients with IBD, Takeda is sponsoring this work to create awareness of the impact of IBD amongst both the general public and policymakers. It is also hoped that this work will encourage the ongoing monitoring of patient reported outcomes in IBD across various countries with the long term result of improving patient care.
Your participation in this Survey is completely voluntary and monetary compensation or reimbursement will not be provided under any circumstances.
Collection and use of personal information
BCG understands that it is important to you that all your personal information be treated confidentially. BCG will not ask for your name, date of birth, any health or social security related identification numbers, nor contact details. BCG will not disclose any patient level data (ie the responses you submit as an individual) to any third party. BCG will only use the data collected from you for the purpose of the Survey, including the internal monitoring and evaluation of the Survey.
For the purposes of the White Paper publication, BCG will combine the data you provide during the Survey with data provided by other participants to generate a set of aggregated survey results (the “Aggregated Information”). The Aggregated Information will neither identify you, nor categorise information you have provided in a manner that would permit someone who knows you to identify you. The Aggregated Information will be used as the basis for undertaking various analyses which will appear in the White Paper, looking at topics such as the quality of life experienced by patients with IBD and the costs associated with the condition.
Data processing and storage
Your data will be collected via a survey tool provided by the Boston Consulting Group that does not allow identification of the participant and will be stored on an internal US-based server at BCG with restricted access to those BCG employees who have a need to access the information. BCG has in place technological and operational security processes designed to protect personally identifiable information from loss, misuse, alteration or destruction. Only authorised employees will have access to any data provided by you, and that access is limited by need.
Each person having access to any personally-identifiable information is obligated to maintain its confidentiality. BCG will take all steps that are generally accepted as industry standard to protect your personally-identifiable information.
Data ownership
BCG and Takeda will be considered the sole owners of the Aggregated Information.
You may access, correct, update, and/or delete as the case may be, any information that you submit to BCG. To do so, please contact us.
CONSENT FORM
You have read and understood the foregoing information, or it has been read to you. You consent voluntarily to participate in this Survey and understand that you have the right to withdraw from the Survey at any time. In addition, to the extent you provide your personal information, you consent to the use and processing of your personal data for purposes of the Survey.
ADVERSE EVENTS & PRODUCT COMPLAINTS
Should you raise during the Survey a product complaint, special reporting situation or an adverse event in a patient or group of patients, so that appropriate follow-up is taken we will need to report this complaint, special reporting situation or event even if it has already been reported by you directly to the company or the regulatory authorities. You will be asked if you are willing to waive the confidentiality given to you under the market research codes of conduct specifically in relation to product complaints, special reporting situations or adverse events. Everything else you report during the course of the survey will continue to remain confidential, and in accordance with market research codes of conduct, your identity and views in association with your identity will not be passed on to any third party.
