Data Collection and Privacy
- Your information will be kept strictly confidential and be stored securely. Access to your identifiable information will be restricted only to study staff at your hospital, with the exception of your date of birth and initials which will be entered into the study database.
- The only people allowed to look at information that could identify you will be your doctors, study staff, authorised representatives of the Sponsor and regulatory authorities who may want to check that the study is being carried out correctly.
- Information about you may be obtained from your health records held at your hospital and other health services for the purpose of this research.
- Information collected for the study will be stored securely at your hospital for 15 years after the study has ended (as per regulatory requirements) and is the responsibility of the Principal Investigator.
- This study is partnered with another adaptive clinical trial known as REMAP-CAP, which is sponsored by Monash University. Both trials are trying to find the best treatment options for patients with acute respiratory infections, such as COVID-19.
- The de-identified data collected in ASCOT will be shared and analysed with data collected in REMAP-CAP, and potentially other studies, to help reach answers more quickly or with more accuracy.
- Information that has had personal identifiers removed (e.g., your name and personal details, with the exception of date of birth and initials) will be replaced with a unique study code. This information will be entered by study staff into a secure password protected web-based database kept on a secure server in Monash University.
- The University of Melbourne (ASCOT Sponsor) and Monash University (REMAP-CAP Sponsor) will be responsible for maintaining the confidentiality of the information in the database.
- In accordance with relevant Australian privacy and other relevant laws, you have the right to request access to your information collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected. Please contact the study team member named on this document if you would like to access your information.