Privacy Notice

Coastal Digestive Health Research Institute (CDH Research Institute) is committed to protecting the privacy and security of your personal information it collects for the purpose of conducting clinical trials.

Coastal Digestive Health Research Institute is subject to applicable legislation in Australia, for example the federal Privacy Act (“the Act”), the Australian Privacy Principles (“APPs”), and state and territory legislation specific to privacy.

Purpose for Collecting Personal Information

Personal Information collected from Clinical Trial Participants is for the purpose of scientific research into the effects of medical treatment and for safety and reliability purposes.

Personal Information can be in any format, including electronic and paper, and consist of, and not be limited to:

• Personal details – date of birth, age in years, sex
• Health data
• Physical details – height, weight, Body Mass Index (BMI)
• Childbearing status
• Physical and mental health data, including medical and surgical histories, medication usage, physical examinations, health assessments (e.g., blood pressure, heart function, x-rays, magnetic resonance images (MRIs)), laboratory testing results from blood, urine and other tissues, and opinions of your disease state or general health
• Psychological details – e.g., quality of life questionnaires
• Data revealing racial or ethnic origin

Clinical Trial Data Transmission

CDH Research Institute is located on the Sunshine Coast in Queensland, Australia. Clinical Trial Data from Clinical Trial Participants will be processed at our site and uploaded to the sponsor portal.  We will ensure that there are adequate measures in place to protect your personal information.

Retention of Information

CDH Research Institute will retain Clinical Trial Data for 15 years in accordance with the retention period for clinical trial data under the Australian Therapeutic Goods Administration (TGA) https://www.tga.gov.au/ legislation.

Your Rights

Your rights related to the clinical trial are described in the Informed Consent Form that you received when enrolling in the clinical trial.

Security Measures

CDH Research Institute has taken appropriate technical and organisational security measures to protect Clinical Trial Data against unintentional or unlawful destruction, loss, alteration, unauthorised disclosure, unauthorised access, and any other unlawful or unauthorised form of processing. Measures include controlling physical access to the data, as well as the relevant access, security of availability and its separation from other data. We also consider the protection of Clinical Trial Data when developing or selecting hardware and software in line with data protection through technology and privacy.

Questions or Complaints Regarding Privacy

When contacting CDH Research Institute about privacy issues by email, please do not include any Personal Information (other than your contact information) in either the subject line or the content of your message. You may contact us with questions or complaints regarding this privacy notice or how we process your information by emailing us on research@coastaldigestivehealth.com.au.