Zuragen™ Clinic Poster
Local Article Example
Q & A
Educational Incentive Program
CRF Re-order Form
CRF Helpful Hints
Hemodialysis Catheter (Material) Types
Temperature Conversion Chart
Issue 9, November 20, 2007
Welcome to Dee Scanlan!
Dee started working on the Ash Study as the Averion
Clinical Project Coordinator in September and has been a great help.
Please be sure to email her your enrollment logs each week!
Her contact information is below:
Welcome to our Newest Study Sites:
Dr. Shetye—Clearwater, Florida
Dr. Bernardo—Houston, Texas
Dr. Germain—Springfield, Massachusetts
Dr. Strom—Boston, Massachusetts
A special thanks to Dr. Cooper’s site in
Phoenix, Arizona. They have enrolled 29
patients since starting on the trial in August!
This is a new trial benchmark!
Monitoring Schedule/CRF BackLog/Outstanding Queries
Our monitors are working hard to catch up with the CRF review and
collection at all sites. Please make sure that you have
completed all outstanding action items and have caught up on your CRF
completion prior to your monitors scheduled visit. We are trying to get
to all the sites every four weeks and appreciate all of your assistance in
allowing us to follow our monitoring timelines. All DCFs received from
StatKing should be completed and returned to StatKing within 7 business
days of receipt. Please make sure you are completing the queries as soon
as possible so that we can continue to keep our databases updated.
- We are in our final push for enrollment. We have 29 patients left to
go and are counting on you to help us reach our goal of completing
enrollment by December 31, 2007.
- It is more important now than ever to make sure you are sending in
your updated enrollment logs each week. This is the only way we will
know if we have reached our goal.
- Once enrollment has been completed, we will be notifying you via fax
and email, so until then, please keep enrolling!
- We appreciate all of the work you are doing to continue
screening/randomizing patients, so please keep it up!
Enrollment Progress As of 11/20/07
Please remember to send in your enrollment log each Friday
|Dr. Hariachar, Hudson, FL (101)
|Dr. Fadem, Houston, TX (103)
|Dr. Rogers, Ocala, FL (104)
|Dr. Block, Denver, CO (105)
|Dr. Kopelman, Bakersfield, CA (106)
|Dr. Al-Makki, Lafayette, IN (107)
|Dr. Henriquez, Bronx, NY (108)
|Dr. Khwaja, Newport Beach, CA (109)
|Dr. Posner, Baltimore, MD (110)
|Dr. Roer, Waterbury, CT (111)
|Dr. Kapatkin, Brandon, FL (112)
|Dr. Halligan, Erie, PA (113)
|Dr. Abbott, Orlando, FL (114)
|Dr. Cheriyan, Fairfax, VA (115)
|Dr. Koeper, Appleton, WI (116)
|Dr. Herman, Buffalo, NY (117)
|Dr. Matalon, New York, NY (118)
|Dr. Williamson (119)
|Dr. Shetye (121)
|Dr. Cooper (122)
|Dr. Besarab (123)
|Dr. Germain (124)
|Dr. Bernardo (125)
|Dr. Strom (126)
The reason that we have so many myths associated with Thanksgiving is that it is an
invented tradition. It doesn’t originate in any one event. It is based on the New England
puritan Thanksgiving, which is a religious Thanksgiving, and the traditional harvest
celebrations of England and New England and maybe other ideas like commemorating the pilgrims. All of these have been gathered together and transformed into something
different from the original parts. - James W. Baker, Senior Historian at Plymouth Plantation
Allie Salvi is now Allie Gorman.
Her new email address is
Please be sure to contact
Rita or Allie with any study
Remember to document a
patient’s BFR at Qb -200 arterial
pressure prior to intervening with
tPA or a radiologic brush if any
suspected patency / flow
challenges are occurring with
their catheter. This number
needs to be below the
which was calculated at the
beginning of the trial and remains
with the patient throughout.
Well, here we are. Sixteen months have now passed since the first patient
was enrolled in the AZEPTIC™ Trial. Sixteen months, thousands of hours
of work and a strong commitment from you, our clinical study team, has
brought us to the verge of completing enrollment – and we are grateful.
Our study’s total enrollment is now 371, and that number is rapidly growing
toward our goal of 400. The good news is that our goal is in sight, yet we
know that finishing the last 10% of any project is always the toughest. The
goal is in sight – and it is clearly achievable. We know that those of you
who have produced the enrollment will continue to work hard toward that
end. And for those of you just coming onto the study, your responsiveness
and results have been incredible. We would never be in the position we
are in with this study unless you were the people “who finish what they
start” and not the “so on’s” that Byrne described.
It is Thanksgiving and the holiday season, and the most important thing we
can do at this time of year is to pause and be thankful for those people who
are closest to us. Our family and our friends make life worth living. So let’s
not let life’s hectic pace cloud that fact for each of us.
And while we are doing so, we at Ash Access are truly thankful for each of you. You have dedicated so much of yourself to reaching your
site’s goals and help our company reach its goal. We understand that this
has often come at the cost of your personal time with family or friends,
which makes us even more appreciative.
So as we look forward, we encourage you to finish strong. Your effort to
identify and enroll new patients is still needed. And just as that is before us,
your diligence in the accurate, thorough and timely completion of
Case Report Forms is also critical. You’ve done a great job in responding
to queries, and continuing that responsiveness remains to be so important.
In turn, we hope you have seen our commitment to you throughout your
time in our study, and we commit to you that our support will continue to
be stronger than ever. Should you need anything to assist your effort, do
not hesitate to contact us. HAPPY THANKSGIVING!
Monitor Phone Number: (765) 413-7676
All questions regarding
Inclusion/Exclusion criteria compliance, potential adverse
device effects, patient safety, and other medical issues related
to the study should be referred to the Medical Monitor.
Since you are reading this page, you are already aware of the Clinical Trial page on this website. Make sure you notice that the Clinical Trial page contains all issues of the study newsletter, a PDF of the trial poster and local newsletter example, site contact information, Q&A log, and CRF re-order form. Please contact Averion or Ash Access if you think of any useful additions to the website, or have any feedback!