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 and Mac users.

 
Template topics andfeatures 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:

• Policies and Standard Operating Procedures for the Institutional Review Board
• Standard Operating Procedures for the Conduct of Good Clinical Research
• Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials

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.

 
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