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AEATF-II Mop Study: Supplemental Slides 1 Initial Protocol Review - PDF document

AEATF-II Mop Study: Supplemental Slides 1 Initial Protocol Review Milestones Jan 08 GPL submits protocol packages to IIRB and CDPR 22 Jan 08 IIRB approves protocol, consent form, recruiting flyer, and recruiting scripts 25 Feb 08 Approved


  1. AEATF-II Mop Study: Supplemental Slides 1

  2. Initial Protocol Review Milestones Jan 08 GPL submits protocol packages to IIRB and CDPR 22 Jan 08 IIRB approves protocol, consent form, recruiting flyer, and recruiting scripts 25 Feb 08 Approved proposal submitted to EPA 10 Mar 08 EPA Science & Ethics Review of proposal 9 Apr 08 HSRB Discussion of proposal 11 Apr 08 CDPR Review calls for revisions of protocol and consent form 25 Jun 08 HSRB final report of April meeting 2

  3. Protocol Revision Milestones 21 Jan 09 IIRB extends approval for another year 27 Jan 09 GPL submits revised proposal to CDPR 19 Feb 09 CDPR grants provisional approval, but calls for more changes 26 Feb 09 GPL submits further revised proposal to IIRB 16 Mar 09 IIRB approves Revised protocol, Consent Form, Recruiting Flyer, and Recruiting Scripts 17 Apr 09 CDPR grants final approval 3

  4. Recruiting/Enrollment Milestones 24 Apr 09 Start of subject recruitment through janitorial services 5 May 09 IIRB approves Protocol, Amendments 1 & 2, Revised Consent Form, Flyer, and Recruiting Scripts 25 Jun 09 IIRB approves Amendment 3 to allow enrollment one-by-one 1 Jul 09 Begin subject enrollment 10 Jul 09 IIRB approves Amendment 4 to recruit by newspaper ads 13 Jul 09 IIRB OK Newspaper recruiting ads 24 Jul 09 Complete subject enrollment 4

  5. Field Monitoring Milestones 27 Jul 09 IIRB approves Amendment 5 to randomize list of all enrolled subjects before assignment to MEs 27 Jul 09 Secured Site 1 (office building) 10-15 Aug 09 Monitoring at site 1 17 Aug 09 Secured Site 2 (retail) 21 Aug 09 IIRB approves Amendment 7 (New CF) 24-29 Aug 09 Monitoring at site 2 8 Sep 09 Secured Site 3 (meeting space) 28 Sep- Monitoring at site 3 3 Oct 09 5

  6. Analysis, QA Milestones 11 Aug 09 GPL begins sample analysis 13 Nov 09 GPL completes sample analysis 15 Jan 10 GPL submits closeout report to IIRB 2 Mar 10 “Last day of data collection” 20 May 10 GPL submits Amendment 6 to IIRB 24 May 10 IIRB approves Amendment 6 4 Jun 10 GPL submits/IIRB accepts Deviation Report 1 28 Jun 10 GPL submits/IIRB accepts Deviation Report 2 28 Jun 10 “Study completion” 6

  7. Molecular Structure of DDAC 7

  8. Gifu’s Earthquake Memorial Hall Dedicated to the Victims of the 28 October 1891 Mino-Owari Earthquake 8

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