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 Clinical Trials was created to
help pharmaceutical and biotechnology companies maintain the quality
performance and ethical conduct of clinical trials.
Biomedical research requires specialized knowledge, which includes
regulatory requirements, Good Clinical Practice (GCP), and medical ethics.
Failure to understand the intricacies of conducting clinical trials may lead to
serious errors in the implementation of a study and compromise the ensuing
data. The first step is to establish operational policies and standard
operating procedures that address these issues.
This SOP template is provided in a three-ring binder with a CD-ROM
containing an MS Word program for Windows users only and is based on FDA
regulations and ICH guidelines.
Template features and topics 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, monitoring clinical trials, human subject protection,
and data handling
Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trialsare 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 Abbreviations
Standard Operating Policy and Procedure for Vendor Selection and a Agreements
Read the license agreement for this
SOP.
For a faxable order form, click here.
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or (866) 219-3440 for more information.
