TMU Coordinators Call Minutes 07/24/2007

TMU Coordinators Call Minutes 07/24/2007

<p>TMU Call Minutes 01/22/2008</p><p>Present Columbia: Marlene Carlson and Fred Jarskog Duke: Mike Crouse and Joe McEvoy MGH/BIDMC (Harvard): Don Goff and Lisa Raeke MPRC: Pat Ball, Bob Buchanan, Jim Gold, Bob McMahon, and Chris Wells NIMH: Adam Haim NKI: Rosemary Coslit, Neikeisha Grenade, and Jim Robinson UCLA: Stephen Marder and Ayala Ofek Wash. U.: Myrtle Carter, John Csernansky, Emily Thomason and Pamela Voss</p><p>Action Items</p><p>Merck  Nothing to report</p><p>Allon  Nothing to report</p><p>Avera  Don Goff – Send DSMB correspondence to Pat Ball  Pat Ball – Send out DSMB correspondence to sites</p><p>Biovalve  Nothing to report</p><p>Epix  Nothing to report</p><p>All Protocols  Bob Buchanan – Sent out ranges for vitals.  All sites – Should send back CS and NCS ranges for vitals to Pat Ball.</p><p>Site Monitoring Visit  Nothing to report</p><p>Notes</p><p>Merck  Site Recruitment review  All sites approved with Inclusion/Exclusion criteria amendment (Columbia pending) Allon  Site Recruitment review</p><p>Avera  DSMB report is available for IRBs  Not all sites may be required to report  If needed please obtain correspondence from Pat Ball</p><p>Biovalve  Nothing to report</p><p>Epix  Developed serotonine 6 receptor antagonist  Created originally for weightloss  Found to improve cognition  Would like to develop protocol to test this  Currently deciding on proper dosage to examine in study  Resultant of negative effects found in 2nd study  Study utilized CANTAB battery  Ok in low dose (300/600mg once daily)  Worse then placebo results for high dose (600mg twice daily)  Drug may possess U-shaped response curve  May be phenomena associated due to confound from illness  fMRI study may not explain results and will take ~one year to complete  “Proof of Concept” study preferred using 300, 600 and 900mg  Face-to-face meeting may be best way to discuss matters with Epix </p><p>All Protocols  Vitals  Abnormal reading flag entries with error  While some entries may be abnormal, the abnormal level may not be clinically significant (or clinically significant)  Database cannot differentiate between vitals that are out of range and “clinically significant” or “not clinically significant”  Pulse, Respiration and EKG should be adjusted to include readings that are “not clinically significant”  CS ranges that require no action will need a note to file included in the subjects file.  If new sites are being added to expand recruitment base, please be sure to update 1572s</p><p>Site Monitoring Visit  Nothing to report</p><p>Next Coordinators call: January 29, 2008 Next TMU call: February 12, 2008</p>

View Full Text

Details

  • File Type
    pdf
  • Upload Time
    -
  • Content Languages
    English
  • Upload User
    Anonymous/Not logged-in
  • File Pages
    3 Page
  • File Size
    -

Download

Channel Download Status
Express Download Enable

Copyright

We respect the copyrights and intellectual property rights of all users. All uploaded documents are either original works of the uploader or authorized works of the rightful owners.

  • Not to be reproduced or distributed without explicit permission.
  • Not used for commercial purposes outside of approved use cases.
  • Not used to infringe on the rights of the original creators.
  • If you believe any content infringes your copyright, please contact us immediately.

Support

For help with questions, suggestions, or problems, please contact us