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 6, April 17, 2007
Newest Member of Ash Team at Averion
As the Ash study continues to grow (from 10 to 20 sites!), so does the Averion in-house
team. Sharon Smith will be the Lead CRA for the Ash study. We hope to get Sharon
out on some co-monitoring visits in the very near future so you can meet her. The
study contact sheet will be updated with Sharon’s contact information and sent to all of
you. In the meantime, if you need to get in touch, she can be reached
at 508-597-6102 or by E-mail at firstname.lastname@example.org
Tip of the Month
Don’t forget to re-screen your screen failures! If a screened patient is a screen failure due to antibiotic use or a positive blood culture, be sure to re-screen the patient once they
become eligible again.
At least one copy of each CRF page needs to be completed
for each patient. If there is no data recorded on a CRF page,
please complete the header information and line through, initial
and date the page.
There will be a Principal Investigator/Study Coordinator
teleconference scheduled for Thursday April 19th at
1:00 PM EDT OR Friday April 27th at 1:00 PM EDT.
An agenda and call in number will be provided prior to
each call. Please email Sharon Smith at
email@example.com, if you haven’t RSVP’d yet.
New Site Updates
Enrollment Progress As of 4/17/07
Please remember to send in your enrollment log each Friday
|Dr. Hariachar, Hudson, FL (101)
|Dr. Stephanz, (102)
|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. Brown (120)
This year is the 111th Boston Marathon.
In terms of on-site media coverage,
the Boston Marathon ranks
behind only the Super Bowl as the
largest single day sporting event in
Helpful Tips from DaVita Labs
When reviewing monthly labs, if you are using the URR equivalent to the Kt/V less than 1.1, the minimum URR should be 68.
If a patient is a screen failure, please be sure to
record the reason for screen failure on the enrollment
log. If you are re-screening a patient, please
be sure to use a new screening number on the
enrollment log. If the original screening number is
required for the lab, be sure to use the new screening
number when logging the information on the
Averion enrollment log.
We like to keep in touch online.
Please send us your current E-mail address for all
study coordinators and Principal Investigators so that
we are able to communicate effectively via E-mail.
Don’t forget to fax your form back to Averion stating
your intention to participate (or if you wish to
decline participation) in the program. If you need
another form, please contact Rita or Allie at Averion.
If you have any questions, please contact Rita (508-597-5773) or Allie (508-597-6223) at Averion.
Don't forget about the available AZEPTIC Trial
patient & dialysis staff resources:
Patient enrollment kits, pens, t-shirts, sponsor
educational inservices, etc.
Please contact Dan Olson at
firstname.lastname@example.org if you have questions.
for additional patient & dialysis staff resources.
Over the course of the past few months, we have shared a great deal
of information about the incidence of catheter related bloodstream infections
and their significant impact on the lives of hemodialysis patients.
Medical advances to reduce or eliminate these infections are in
great demand, not only for patients in hemodialysis, but patients in
acute and chronic hospital care.
We at Ash Access Technology are committed to meeting this unmet
need. Our company was founded on the research and clinical successes
of Dr. Stephen Ash. Dr. Ash’s relentless problem-solving pursuit,
joined with the business acumen of our President and CEO, Bob
Truitt, provide the cornerstones of our company.
We have assembled a team of employees, who effectively put our
plans in motion. Many of you have met Carmine, Dan, Al and Roland.
Dr. Janusz Steczko and Lloyd Brewer provide R&D under Dr. Ash’s
direction and Ken Brown, an accomplished medical device engineer,
manages our hemodialysis and peritoneal catheter projects. We are
also grateful to have a solid and engaged Board of Directors who bring
many years of experience and practical wisdom.
The folks that comprise our company are driven by our shared passion
to solve the catheter infection challenge. And as much as we enjoy
our individual work in pursuing this goal, we also enjoy getting to do
this work together. Our team is indeed a team.
Yet, our founders, our employees, and our board do not complete the
picture of our company. At this particular point in time, though, the
most significant people on our team have not yet been mentioned. For
at this time, a time where our company’s flagship product is in its final
clinical study prior to FDA approval, the people carrying out that study
are absolutely essential to our success. You are the most significant
people we’ve got. You will be the ones to say “I was part of significantly
improving the way the world cares for catheter patients.” We
hope you are as excited as we are in seeing yourselves in such a
unique role for such a unique product and such a unique opportunity.
Your commitment and hard work are paying off. The Enrollment Surge
has begun, and with your continued dedication, we will complete this
study, and we will all be proud. We look forward to supporting your
work and seeing your successes in the weeks ahead. Thank you!
Device Accountability Logs
Please be sure you are keeping the Device Accountability Logs current and up to date at each of your dialysis units.
It is important to accurately log the use of all Zuragen at each dialysis unit. The Dialysis Binders provided to each
site/satellite site includes a Device Accountability Log—you should be using the Device Transfer Forms to document
moving the device from one unit to another. If you have any questions with this process, please contact the in-house
team at Averion or your monitor.
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!