Writing and Managing SOPs for GCP: 1st Edition (Hardback) book cover

Writing and Managing SOPs for GCP

1st Edition

By Susanne Prokscha

CRC Press

224 pages | 9 B/W Illus.

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Description

Writing and Managing SOPs for GCP isthe 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.

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

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

About the Author

Susanne Prokscha is a director in clinical data management for process and training at Onyx Pharmaceuticals in San Francisco, California. Shehas 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.

Subject Categories

BISAC Subject Codes/Headings:
COM021000
COMPUTERS / Database Management / General
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General