Confidentiality {27}
Data protection and data security measures will be implemented for the collection, storage and processing of patient data in accordance with principles 6 and 12 of the World Health Organization Good Clinical Research Practice handbook. Participants’ data will be collected via a secure electronic data capture system. System access rights will be controlled by BI, and dataset access will be limited to BI. BI endorses the Principles for Responsible Clinical Trial Data Sharing set out by the Pharmaceutical Research and Manufacturers of America and the European Federation of Pharmaceutical Industries and Associations. BI provides redacted clinical study reports and clinical documents on request. Furthermore, BI provides qualified scientific and medical researchers access to de-identified, analysable patient-level clinical study data. Further information can be found on BI’s Data Transparency website (Individual patient data obtained as a result of this trial are considered confidential, and disclosure to third parties is prohibited with the following exception: personalised treatment data may be given to the patient’s personal physician or to other appropriate medical personnel responsible for the patient’s welfare. Data generated at the site as a result of the trial will be available for inspection on request by the participating physicians, the sponsor’s representatives, the IRB/IEC and regulatory authorities.Before providing any copy of patient source documents to the sponsor or external suppliers, the investigator will ensure that all patient identifiers (e.g. name, initials, address, telephone number and social security number) have been removed or redacted.