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Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials

ISBN-10
1-933040-24-6

Publication date:
2005

Page count:
137

Preview sample pages:
Table of Contents

Introduction

List of Abbreviations

Standard Operating Policy and Procedure for Vendor Selection and a Agreements

Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials

Authors: Anna J. DeMarinis, M.A.,MT (ASCP) SBB, CQA (ASQ); Carol Saunders, RN, BSN; Herbert Swarz, M.D.

Format(s):

Price: $4,200.00 

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Standard Operating Procedures for Good Clinical Practice by Sponsors of Clinical Trials was created to help pharmaceutical and biotechnology companies maintain the qualityperformance and ethical conduct of clinical trials.

Biomedical research requires specialized knowledge, which includesregulatory 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 standardoperating 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 and Mac users 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

Recommended for:

  • Professionals at pharma and biotech companies involved with clinical trials
  • Professionals involved in clinical operations or clinical affairs
  • Quality assurance and regulatory professionals
  • Professionals involved with compliance to FDA, ICH and GCP guidelines

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: