Authors: Anna J. DeMarinis, M.A.,
MT (ASCP) SBB, CQA (ASQ); Carol Saunders, RN, BSN; Herbert Swarz, M.D.
Standard Operating
Procedures for Good Clinical Practice by Sponsors of Medical Device Clinical Trials
provides detailed SOPs to address specific requirements.
Organizations that sponsor clinical
research on new medical devices must implement procedures that adhere to both Good Clinical Practice guidelines (GCP) and federal
regulations. Although GCP is universally applicable to all types of clinical research, medical device research practices must adhere
to a discrete set of FDA regulations and guidance.
This SOP template is provided in a
three-ring binder with a CD-ROM containing an MS Word program for Windows users only.
Template topics and
features include:
- 30 SOPs addressing all GCP requirements and 80 detailed procedures
- Forms, checklists, and templates to integrate and document compliance
- Chapters on regulatory submissions and reporting, investigator selection and
qualification, ensuring investigator compliance, and monitoring clinical trials
Standard Operating
Procedures for Good Clinical Practice by Sponsors of Medical Device Clinical Trials
is also designed to be compatible with the other SOP templates in the series, which include:
To preview the
Table of Contents and other sample pages, click on the links below:
Table of Contents
Introduction
List of Attachments
Read the
license agreement for this SOP.
For a faxable
order form, click here.
Please contact
sales@centerwatch.com or (866) 219-3440 for more information.
