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 sponsors.

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 protocol.

This pocket-sized (4.25"), laminated wheel is a useful way to quickly categorize adverse events. $15.00 US.

Biocompatibility Testing and Management, Fourth Edition (2003)

Stark NJ, Biocompatibility Testing & Management, Fourth Edition, Clinical Device Group Inc, Chicago, IL (2003). Perfect bound, illustrated, 350 pages. ISBN 1-889160-11-3. $250.00 US.

Biological Safety Model Quality System

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 Trials Design, Third Edition (2000)

Stark NJ, Clinical Trials Design, Third Edition, Clinical Device Group Inc, Chicago, IL (2000). Perfect bound, illustrated, 300 pages. ISBN 1-889160-02-4. $250 US.

Clinical Research Model Quality System

Gross income >$1M

$5000

Gross income $300K - $1M

$3775

Gross income up to $300K

$1500

Stark NJ, Clinical Research Quality System, 2009 Edition, Clinical Device Group Inc, Chicago, IL (2009). Three-ring bound. ISBN: 1-889160-18-0. 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 Edition

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. $50 US.

Date Wheel

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.