Adverse Event Wheel
The Adverse Event Wheel is a convenient 'dictionary'
of adverse event definitions for medical device studies. The definitions
are taken from 21 CFR Part 812, ISO/DIS 14155 Clinical Investigations
for Human Subjects--Good Clinical Trials (2008), and ISO 14155 (2003);
and is suitable for both investigational sites and clinical trial
When an event occurs, you spin the wheel until it
lands on the set of characteristics that fit the event (subject or
caregiver, device-related or not, serious or not, unanticipated or not,
unreasonable risk or not). The universal definitions are given on the
back of the wheel, along with instructions to report as described in the
This pocket-sized (4.25"),
laminated wheel is a useful way to quickly categorize adverse events. $15.00 US.
Certified Copy Stamp
Eventually you'll need
to photocopy a document and then verify that it is a true copy of the
original. Make it official with a red-inked Certified Copy stamp; convenient
footprint of 5/8" by 1 3/4". US $25.
Clinical Research Model Quality System
Gross income $300K
Gross income up to $300K
Stark NJ, Clinical Research Quality System,
2009 Edition, Clinical Device Group Inc,
Chicago, IL (2009).
Price based on company's gross income.
CRA Handbook 2009 Edition
Stark NJ, CRA Hanbook, 2009 Edition, Clinical Device Group Inc, Chicago, IL
(2009). Comb bound, illustrated,
190 pages. ISBN 1-889160-17-2. $50 US.
CRA Handbook 2009 Electronic
Stark NJ, CRA Handbook, 2009 Electronic Edition, Clinical Device Group Inc,
Chicago, IL (2009). Illustrated eBook on secured PDF. Link to downloadable file
delivered by email; 3MB file size; Resides on your hard drive, fully searchable
and easy to use. ISBN number 1-889160-20-2.
Buy a gift for your hard-working site
coordinator! The Date Wheel is a circular calendar for calculating follow-up
visit appointments. Flexible and coffee resistant, plastic laminated for
endurance, pocket-size. $8.00 each.
Investigator's Guide to Clinical Research
Stark NJ, Investigator's Guide to Clinical Research,
Clinical Device Group Inc, Chicago, IL. (2002)
Perfect bound, illustrated,
182 pages. ISBN 1-889160-19-9. $100 US.
Stark NJ, ed. US Guidances 2009 Edition, Clinical Device Group Inc, Chicago,
IL. eBook on secured PDF file. Link for downloadable file delivered by email;
19MB file size; Resides on your hard drive, fully searchable and easy to use.
ISBN 1-889160-21-0. $175 US.
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