1st Edition

Writing and Managing SOPs for GCP

By Susanne Prokscha Copyright 2016
    224 Pages 9 B/W Illustrations
    by CRC Press

    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.

    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

    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.

    "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