How is information from a clinical trial kept confidential?
This information includes each person’s:
• medical history and diagnosis
• gender and race
• height and weight
• response to the trial medicine – that is, how it worked in treating the person’s disease
• side effects, if any, during the clinical trial.
This information is kept in special trial forms on a computer. On these forms, people are identified only by a trial participant number and when they were born.
Names and other information that can directly identify people, such as an address or personal ID number, is not included on these forms. The link between the trial participant number and the information that can directly identify the person is stored at the clinical trial site. It will be kept for as long as it is required by local laws. This is in line with the regulations of Good Clinical Practice, which apply to all clinical research with people. Names or other information that can directly identify the people taking part will never be shared outside of the clinical trial.
Clinical trial information is protected by the regulations of Good Clinical Practice and any local data privacy laws and regulations that apply. This ensures strict control over who can access the information. Information is kept confidential as far as possible.
Important information regarding LEO Pharma Clinical Trial Disclosure
Access to the site requires that you acknowledge and accept the following:
- The information on this website is provided solely to increase transparency of LEO Pharma clinical trials. It is not intended to promote any prescription, sale, or use, whether approved or off-label, of any medicinal product from LEO Pharma or from any other company.
- The documents on this site have been prepared in accordance with applicable ICH guidelines upon completion of the respective clinical trials. Except edits necessary for the protection of commercially confidential information and those for the protection of personal data, the documents are in the same format as they were originally prepared for approvals from the regulatory authorities.
- The documents provided on this site contain data and results regarding approved and non-approved uses, formulations or treatment regimens. As data and results from clinical trials are of a scientific nature, you cannot rely on this information as a recommendation or advice regarding the use/non-use of any products or treatment options.
- The information is not intended to replace the advice of a healthcare professional. As a patient, you must always consult your doctor for further information and instructions.
- The information is not intended to be used by physicians for making prescribing decisions. If you are a physician, you should always refer to the specific authority-approved labelling information approved for the product in the country or region of the patient.