Clinical Trial Privacy Policy

This policy sets forth the policy of Liquidia Technologies, Inc. (“Liquidia” or “Sponsor”) with respect to data and records generated in connection with research studies.  You may also find this information in the Informed Consent that you signed in connection with your participation in a research study with Liquidia (the “Informed Consent”).  In the event of any conflict between this policy and your Informed Consent, your Informed Consent will control.

What will happen to your data?

This research study may be performed only by collecting and using your medical information. Anyone with access to your study records is required to keep your information confidential. Only a code number will be used to identify you and your samples. You will not be personally identified in any reports or publications that may result from this research study.

The study personnel, the Sponsor and its agents will need to review the medical information collected from you for use in this study in order to accurately record information for this study. In addition, in order to review the study findings, the US Food and Drug Administration (FDA) and other regulatory agencies may review your medical records. The following sections provide a specific description of how your information will be used and disclosed if you participate in this research study. By signing this consent form, you are authorizing such access. If you do not sign this form to authorize access, you will not be able to participate in this research study.

The medical information that will be collected from you if you participate in the study includes the following:

• Information obtained from procedures to determine your eligibility to participate in the study, including a routine medical history, physical examination, chest x-ray, ECG, blood and urine tests, echocardiogram, and spirometry testing
• Information that is created or collected from you during your participation in the study, including the results of the tests included in previous bullet point and any other procedures performed during the study
• Information contained in your medical records that is related to your medical history and treatment

The above information may identify you by name, address, telephone number, social security number, health plan number, study number, date of birth, dates of various medical procedures, and other identifying information.

If you sign this form and participate in the study, the study personnel will be authorized to use the information described above for the purposes of the research study. The study personnel will also be authorized to access the relevant information described above to the following parties involved in the research study:

• Liquidia Technologies (the Sponsor), the CRO or other agents designated by the Sponsor to collect or review study data for verification of study procedures and/or side effect reporting
• Other employees or students of the Sponsor or its authorized agents, who may accompany study monitors and auditors for quality and training purposes
• The IRB that oversees the research study at your site
• Government regulatory agencies, including the US FDA

The Sponsor has contracted a vendor that will deliver your study medication and device. They will know your real identity but will only be informed about your medical condition if it is necessary to perform their service.

Once your information is disclosed to the Sponsor, its agents, the IRB, or government agencies as described above, it is possible that your medical information will be re-disclosed and will no longer be protected by US federal privacy regulations. In addition to disclosures to the entities identified above, your coded health information may also be electronically disclosed to others involved in the research study, such as the following:

• Laboratories or offsite testing facilities for clinical tests required by study protocols
• Approved offsite storage facilities or cloud service providers to meet study record retention and storage requirements
• The Sponsor who directs the medical research studies
• Other third parties contracted by the Sponsor to provide services related to studies

The study data may be transferred to other countries for processing, including countries that are not covered by data protection legislation. The laws of your state may provide further protection.

While the study is in progress, your access to your study records will be temporarily suspended. You will be able to access your information when the research study is completed. You have the right to see and copy the medical information collected from you in the course of the study for as long as that information is maintained by the study personnel and other entities, subject to federal privacy regulation.

Study data, including your coded medical information, may be used and shared for pharmaceutical research purposes related to this study. This authorization has no expiration date. In signing this form, you authorize the use and disclosure of your information for purposes of the study at any time in the future.

You may withdraw your authorization at any time by sending a written request to your study doctor at their practice address. If you withdraw your authorization, data collected prior to your withdrawal may still be processed along with other data collected as part of the study. Normally, no new information will be collected for the study database unless you specifically consent it. However, the law does require that any side effects that you experience are documented and reported. To complete the study findings, your long-term health status may also be obtained from public sources.

This clinical study may only be performed by collecting and using your medical information. Therefore, by signing this form, you specifically authorize your relevant information to be checked, transferred, and processed as follows:

• The authorized representatives of Liquidia Technologies, the IRB, and inspectors for regulatory authorities may review your medical information by directly accessing your medical records.
• Study data and all specified study-related documents, including your coded medical information, will be stored for a minimum of 25 years and may be used and shared for legitimate study and scientific purposes during this time.