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T2016-003 Dec/Vor

Protocol Opened: July 21, 2017

Study Contacts

  • Protocol Chair: Michael J. Burke, MD
  • Protocol Vice-Chair: Deepa Bhojwani, MD
  • Study Biology Chair: Sridhar Rao, MD, PhD

 

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 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
Amendments
CRFs and Roadmaps
Adverse Events and DLT
Correlative Studies
Data Safety Monitoring and Progress Reports
Enrollment Procedures