1st Edition

Writing and Managing SOPs for GCP




ISBN 9781482239355
Published July 29, 2015 by CRC Press
224 Pages 9 B/W Illustrations

USD $155.00

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Book Description

Writing and Managing SOPs for GCP is the first book to discuss managing Standard Operating Procedures (SOPs) for Good Clinical Practice (GCP) from conception to retirement. It recommends approaches that have a direct impact on improving SOP and regulatory compliance. Throughout the text, the book provides a user’s point of view to keep topics focused on the practical aspects of SOPs and SOP management.

The idea of specifically calling out approaches to SOP creation and maintenance in an effort to make it easier for users to stay in compliance is a theme found throughout all book chapters. Examples in each chapter provide accurate reflections of real-world experiences to illustrate the discussion. The book also includes an example "SOP of SOPs" along with an associated SOP template.

Table of Contents

FOUNDING PRINCIPLES

Introduction to SOPs

What Is an SOP?
Why Do We Have SOPs?
Why Do We Follow SOPs?
Beyond SOPs
Say What We Do, Do What We Say

Document Hierarchies

Controlled Documents and Managed Documents
Overview of the Hierarchy
More about Controlled Document Types
More about Managed Document Types
Other Document Types
Hard-to-Classify Documents
SOP of SOPs

When to Have an SOP

Should It Be an SOP?
When an SOP Is Not Needed
Other Ways to Introduce Consistency
SOP of SOPs

What the SOP Should Say

Who, What, When, and Where
How and the Level of Detail
Cover One Topic or Many Topics?
Too Many or Too Few SOPs
SOP of SOPs

Where to Put the Output

What Is a Trial Master File?
Contents of a TMF
The TMF Connection to SOPs
Not All Documents Belong in the TMF
SOP of SOPs

WRITING, REVIEWING, APPROVING, AND POSTING


Who Writes SOPs?

Which Department Provides the Author?
Selecting an Author
Clinical Development’s Controlled Document Group
SOP of SOPs

Document A Stable Process

SOPs Should Not Be Theoretical
Testing a Procedure
When You Cannot Pilot
SOP of SOPs

Mapping a New Process

Assemble a Team
Review Regulatory Requirements
List Steps or Actions in the Right Order
Who Is Responsible? Who Is Involved?
Identify Inputs and Outputs
Be Aware of Sequence and Prerequisites
Translate the Process into an SOP
Stay Aligned with Any Approved Process Maps
SOP of SOPs

The SOP Template

Document Header
Purpose and Scope
Definitions and Background
Responsibility
Procedure
Document Disposition
References
Appendices
Revision History
Other Considerations
SOP of SOPs

SOP Review and Approval

Concentric Rings of Review
Best Practices for Review
Approval
How Long Does this Take?
Reviewing Documents from Other Departments
SOP of SOPs

Posting: Setting Up for Success

Is it Really Ready to Post?
Communication Plans
SOP Release Cut-Over Rules
Posting SOPs
SOP of SOPs

MAINTAINING SOPs; MAINTAINING COMPLIANCE


Deviations from Controlled Procedures

Retrospective Deviations
Prospective Deviations
Documenting Deviations
Deviations from Supporting Documents
Is It Really a Deviation?
SOP of SOPs

Active SOP Maintenance

The Environment Changes
Documents Change
Initiating an Update
Regular SOP Review
SOP of SOPs

HELPING STAFF FOLLOW SOPs


Finding SOPs

Controlled Document Identifiers
Internal Web Pages
Indexes
SOP of SOPs

Training on SOPs

Options for Training
Who Has to Train on Which SOPs?
Training Periods
Delta Training and Minor Releases
SOP of SOPs

Department-Managed Documents

Founding Principles
Writing, Reviewing, Approving and Posting
Maintaining Compliance
Helping Staff Use Department-Managed Documents
The Document on Department-Managed Documents

ADDITIONAL TOPICS


Where to Start

When the Company Is Virtual
Small Companies Taking on Activities
As the Company Continues to Grow

SOPs During Mergers and Acquisitions

At First
The Transition Period
Later
Trial Master Files
SOP on Acquisitions and Mergers?

Controlled Glossaries

Starting the Glossary
Role Names in the Glossary
Maintaining the Glossary
Using Glossaries

Example SOP Template


Example SOP of SOPs

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Author(s)

Biography

Susanne Prokscha is a director in clinical data management for process and training at Onyx Pharmaceuticals in San Francisco, California. She has been involved in clinical data management (CDM) processes and technologies since the mid-1980s. Ms. Prokscha has worked both as a consultant and directly for large and small companies, gaining experience with a wide range of studies and a variety of clinical data management systems. Her interest in advancing the field of CDM and helping emerging CDM groups led her to write Practical Guide to Clinical Data Management. She currently focuses on process development, SOP writing, document management, and training for CDM and Biometrics groups.

Reviews

"Writing and Managing SOPs for GCP miraculously transforms the boring floss of standard operating procedures into the interesting gold of…SOPs. A reader of this book will find it is hard to imagine managing SOPs without having read the book."
—Norman M. Goldfarb, in Journal of Clinical Research Best Practices, Vol. 12, No. 2, February 2016