Adverse Event Note/Mouse Pad

 

The Adverse Event Pad 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 (2010); and is suitable for both investigational sites and clinical trial sponsors.

When an event occurs during a clinical investigation, locate its characteristics on the inner circles of the wheel, and then identify the type of adverse event from the outer circle.

This note/mouse pad (8 7/8'' x 7 1/4 "), has 10 pages and is a useful way to quickly categorize adverse events. $8.00 US.

Biocompatibility Testing and Management, Fourth Edition (2003)

Stark NJ, Biocompatibility Testing & Management, Fourth Edition, Clinical Device Group Inc, Chicago, IL (2003).

This book is as meaningful today as the day it was written. Perfect bound, illustrated, 350 pages. ISBN 1-889160-11-3. Table of Contents. $250.00 US.

Biological Safety Quality System Manual

Biocompatibility Test Matrix Note/Mouse Pad

The Biocompatibility Test Matrix Pad is a convenient tool for identifying biocompatibility tests. Identify device or material by nature of body contact and contact duration. Then select the categories of biological safety tests recommended by the current version of ISO 10093-1 in black numbers and by US G95-1 in red numbers.

This note/mouse pad (8 7/8'' x 7 1/4 "), has 10 pages and is a useful way to quickly make test selection. $8.00 US.

Stark NJ, Applied Regulations, Third Edition, Clinical Device Group Inc, Chicago, IL. (2002). Perfect bound, illustrated, 270 pages. ISBN 1-889160-02-4. Table of Contents. $250 US.

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". Description. $25 US.

Stark NJ, Clinical Evaluation Report Procedure and Template, 2009. Delivered by email.

An editable standard operating procedure and clinical evaluation report template available as Word documents. The procedure and template are based on the recommendations of GHTF Study Group 5, the requirements of MEDDEV 2.7.1, the essential requirements of the MDD 93/42/EEC, and the AIMD 90/385/EEC. They may be used to prepare clinical evaluation reports for the European market and the resulting reports have been accepted by Notified Bodies. These proven instructions have been personally developed by Dr. Nancy J. Stark, requiring more than 80 hours of labor.

For those who wish to develop their own clinical evaluation reports these time-saving, customizable documents will provide your staff with step-by-step instructions. US$ 5000.

Stark NJ, Clinical Trials Design, Third Edition, Clinical Device Group Inc, Chicago, IL (2000). Perfect bound, illustrated, 300 pages. ISBN 1-889160-02-4. This is one of the few books about writing protocols and designing trials that links study hypotheses to product claims. It is intended for use by medical device manufacturers. Table of Contents. $250 US.

Clinical Research Quality Management System Manual

Stark NJ, Clinical Research Quality Management System Manual, 2009 Edition, Clinical Device Group Inc, Chicago, IL (2009). You receive editable Word documents of the entire system on CD, and an easy-to-read paper copy that is three-ring bound for notes and organization ideas. ISBN: 1-889160-18-0. Table of Contents. $3000.

Stark NJ, CRA Handbook, 2011 Edition, Clinical Device Group Inc, Chicago, IL (2011). We designed the CRA Handbook to put the device regulations, FDA monitoring guidance, ISO 14155 outline and checklists, and checklists of clinical trial documentation in one convenient location. People tell us their old handbooks are full of 'stickies', margin notes, highlights, and folded corners as they mark the paragraphs important to them.

The 2011 version was updated for consistency with the international standard ISO 14155 "Clinical Investigations of Medical Devices in Human Subjects—Good Clinical Practices," Part 809 was added in recognition of the increasing importance of in vitro diagnostic products, and a list of the diverse and often difficult-to-find horizontal FDA standards relating to device trials was added, for a total of 16 chapters. Many people want a paper copy for their briefcase and an electronic copy for their laptop.

The paper edition is comb-bound, compact, lies flat for easy reading, and lends itself to field notes, 220 pages, 15 figures and tables. ISBN 1-889160-24-4. Table of Contents. $50 US.

CRA Handbook 2011 Electronic Edition

Stark NJ, CRA Handbook, 2011 Electronic Edition, Clinical Device Group Inc, Chicago, IL (2011). The illustrated e-book is offered as a secured non-printable pdf Acrobat document.

The 2011 version was updated for consistency with the international standard ISO 14155 "Clinical Investigations of Medical Devices in Human Subjects—Good Clinical Practices," Part 809 was added in recognition of the increasing importance of in vitro diagnostic products, and a list of the diverse and often difficult-to-find horizontal FDA standards relating to device trials was added, for a total of 16 chapters and 15 tables and figures. Many people want an electronic copy for their laptop and a paper copy for their briefcase.

Designed to upload to your hard drive, be fully searchable, and annotate-able with Acrobat Writer; the 3MB file is delivered by email. ISBN number 1-889160-25-3. Table of Contents. $50 US.

Date Wheel/Project Wheel

The Date Wheel is a circular calendar.

Some people give them to their investigative staff for calculating subject's follow-up visit appointments.

Other people buy for their project team to help plan project schedules. For example, I can set the arrow at today's date and count ahead, say, 8 weeks to get the date I'll finish a protocol. Then I move the schedule ahead another 4 weeks to get the date I'll finish the case report forms, and so on.

Flexible and moisture-resistant, plastic laminated for endurance, pocket-size. Description. $10.00 each.

Stark NJ, Good Monitoring Practices, Fourth Edition, Clinical Device Group Inc, Chicago, IL (2004), 240 pages. Perfect bound, illustrated. ISBN 1-889160-02-4. Table of Contents. $250 US.

Stark NJ, Investigator's Guide to Clinical Research, Clinical Device Group Inc, Chicago, IL. (2002) Perfect bound, illustrated, 182  pages. This short, direct-to-the-point book, is intended to help you train new investigators to current good clinical practices. ISBN 1-889160-19-9. Table of Contents. $100 US.