Confidentiality {27}
RAVE
Study identifiers will be strictly protected in this study. Subjects are assigned a unique study identification number, which is used on all electronic data files and study forms with the exception of the screening log. Identifying information such as name, date/time of birth, and medical record number (MRN) will be used on screening log for documentation and tracking purposes. Name and MRN will not be entered into the online study databases RAVE and REDCap. The password-protected screening log will be securely stored on hospital password-protected computers only. The log will be destroyed at the end of the study. Confidentiality will be protected by removing any information that can be associated with date/time of birth and other dates/time data points. The link between the identifying numbers and names will be securely locked and accessible only to personnel of the Weaning Trial including study coordinator and PI. Data for the in-hospital weaning data collection forms will be entered into the Medidata RAVE Electronic Data Capture (EDC) system. Medidata RAVE is a CFR 21 Part 11 compliant Electronic Data Capture System with ISO 27018 privacy protection certification. The RAVE system is an interface for data capture, queries, data cleaning, and site monitoring and reporting.In-hospital weaning data abstraction and collection forms will be entered into the web-based online EDC system RAVE database electronically, verified and stored without identifying information. REDCap EDC will be used for the post-hospital discharge questionnaires and follow-up data. Participants can complete study questionnaire electronically via REDCAP. These electronic data files are linked to the participant by the unique participant identification number only.