Protocol Opened: July 21, 2017
Study Contacts
CURRENT STUDY DOCUMENTS
T2016-003 Protocol Amendment #4 7-01-2019 (clean) | T2016-003 Protocol Amendment #4 7-01-2019 (clean) |
T2016-003 Protocol Amendment #4 7-01-2019 (tracked) | T2016-003 Protocol Amendment #4 7-01-2019 (tracked) |
Amendment #4 Summary of changes 7-01-2019 | Amendment #4 Summary of changes 7-01-2019 |
Amendment #4 Sample consent clean 7-01-2019 | Amendment #4 Sample consent clean 7-01-2019 |
Amendment #4 Sample consent redline 7-01-2019 | Amendment #4 Sample consent redline 7-01-2019 |
T2016-003 Amendment #4 Eligibility Worksheet | |
T2016 -003 Research Monitoring Plan | T2016-003 Research Monitoring Plan |
T2016-003 Amendment #4 Investigator Acknowledgement | T2016-003 Amendment #4 Investigator Acknowledgement |
FDA Approval Letter IND Exempt | FDA Approval Letter IND Exempt |
T2016-003 Investigator Meeting Presentation | T2016-003 Investigator Meeting Presentation |
T2016-003 Investigator Meeting Presentation Site Training Log | T2016-003 Investigator Meeting Presentation Site Training Log |
STUDY DOCUMENT ARCHIVE
T2016-003 (Amendment 1) Protocol 06Sep17 | T2016-003 (Amendment 1) Protocol 06Sep17 (clean) |
Amendment 1 Summary of Changes | Amendment 1 Summary of Changes |
Original T2016-003 Protocol 1-20-17 (clean) | Original T2016-003 Protocol 1-20-17 |
Sample Consent 1-20-17 | Sample Consent 1-20-17 |