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| − | The Stage I-B and II teleconferences are bi-weekly and are on alternating week.
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| − | The Stage I-B meetings are scheduled for Thursday.
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| − | The Stage II meetings are scheduled for Wednesday.
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| | '''Teleconference Information''' | | '''Teleconference Information''' |
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| | Passcode: 745896 | | Passcode: 745896 |
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| − | '''Stage I-B Webinar Info:'''
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| − | https://www.webmeeting.att.com
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| − | Meeting # 8662132145
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| − | Participant Code 3172766628
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| | '''Stage II Webinar Info:''' | | '''Stage II Webinar Info:''' |
| − | https://www302.livemeeting.com/cc/globalsubmit/join?id=CDISCHL7&role=attend | + | To join the meeting via Adobe Connect: https://collaboration.fda.gov/fdscm/ |
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| − | ----
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| − | '''Meeting Dates, Times, and Agendas'''
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| − | ----
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| − | '''Stage II'''
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| − | '''Date:''' Wednesday, October 1, 2008
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| − | '''Time:''' 11:00AM - 1:00PM (EST)
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| − | '''Agenda:''' (1) Define experimental ID (Hernandez) and
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| − | (2) Continue with the SDTM exposure domain (EX) and start with adverse events (AE) and labs (LB) if time permits in à HL7 Study Participation RMIM classes and attributes mapping discussion
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| − | ----
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| − | '''Stage I-B''' Out-of-Cycle meeting
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| − | '''Date:''' Thursday, October 2, 2008
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| − | '''Time:''' 11:00AM - 12:00PM (EST)
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| − | '''Agenda:''' BRIDG GAP Harmonization
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| − | '''Stage I-B'''
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| − | '''Date:''' Thursday, October 9, 2008
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| − | '''Time:''' 11:00AM - 12:00PM (EST)
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| − | '''Agenda:''' BRIDG GAP Harmonization
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| − | ----
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| − | '''Stage II'''
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| − | '''Date:''' Wednesday, October 15, 2008 '''RESCHEDULED to Wednesday, October 22, 2008'''
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| − | '''Time:''' 11:00AM - 1:00PM (EST)
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| − | '''Agenda:''' TBD
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| − | ----
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| − | '''Stage I-B'''
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| − | '''Date:''' Thursday, October 23, 2008
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| − | '''Time:''' 11:00AM - 12:00PM (EST)
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| − | '''Agenda:''' DAM Mapping, October 30-31, 2008 meeting agenda
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| − | ----
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| − | '''Stage I-B Face-to-Face Meeting'''
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| − | '''Date:''' Thursday, October 30, 2008 and Friday, October 31, 2008
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| − | '''Time:''' October 30th - 1:30PM - 5:00PM (EST)
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| − | '''Location:''' Marriott Crystal Gateway, 1700 Jefferson Davis Hwy, Arlington, VA 22202 - Madison Conference Room (Ground Level)
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| − | '''Agenda:''' Project ballot status, DAM, Subject Data requirments and storyboards
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| − | '''NOTE:''' Different Dial-in number: 1.866.803.2146 and Passcode 2794274
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| − | ----
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| − | '''Stage II'''
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| − | '''Date:''' Wednesday, October 29, 2008 '''RESCHEDULED to Wednesday, November 5, 2008'''
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| − | '''Time:''' 11:00AM - 1:00PM (EST)
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| − | '''Agenda:''' TBD
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| − | ----
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| − | '''Stage I-B'''
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| − | '''Date:''' Thursday, November 6, 2008
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| − | '''Time:''' 11:00AM - 12:00PM (EST)
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| − | '''Agenda:''' TBD
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| − | ----
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| − | '''Stage II''' '''CANCELLED'''
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| − | '''Date:''' Wednesday, November 12, 2008
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| − | '''Time:''' 11:00AM - 1:00PM (EST)
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| − | '''Agenda:''' TBD
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| − | ----
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| − | '''Stage I-B'''
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| − | '''Date:''' Thursday, November 20, 2008
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| − | '''Time:''' 11:00AM - 12:00PM (EST)
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| − | '''Agenda:''' Review Subject Data storyboards
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| − | ----
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| − | '''Stage II'''
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| − | '''Date:''' Wednesday, November 26, 2008
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| − | '''Time:''' 11:00AM - 1:00PM (EST)
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| − | '''Agenda:''' Review and discuss Study Participation and Study Design DSTU (September 2008)ballot comments
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| − | ----
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| − | '''Stage I-B'''
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| − | '''Date:''' Thursday, December 4, 2008 '''CANCELLED'''
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| − | '''Time:''' 11:00AM - 12:00PM (EST)
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| − | '''Agenda:''' Review Subject Data storyboards
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| − | ----
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| − | '''Stage II'''
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| − | '''Date:''' Wednesday, December 10, 2008
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| − | '''Time:''' 11:00AM - 1:00PM (EST)
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| − | | |
| − | '''Agenda:''' Review and discuss Study Participation and Study Design DSTU (September 2008)ballot comments
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| − | ----
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| − | '''Stage I-B'''
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| − | '''Date:''' Thursday, December 18, 2008
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| − | '''Time:''' 11:00AM - 12:00PM (EST)
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| − | '''Agenda:''' Review Subject Data storyboards
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| − | ----
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| − | '''Stage II'''
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| − | '''Date:''' Wednesday, December 24, 2008 '''RESCHEDULED to Wednesday, December 17, 2008'''
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| − | '''Time:''' 11:00AM - 1:00PM (EST)
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| − | '''Agenda:''' Review and discuss Study Design DSTU (September 2008)ballot comments
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| − | ----
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| − | '''Stage I-B'''
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| − | '''Date:''' Thursday, January 1, 2008 - HOLIDAY "No Meeting"
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