SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sites

To keep up with the always-evolving GCPs, your organization needs to spend valuable time updating or creating SOPs to reflect recent developments from the FDA.

We have done some of the work, so you do not have to. With SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sites, you can customize these SOPs easily to match your culture and internal processes. No matter your organization’s size or complexity, you’ll benefit greatly from this comprehensive compliance library. It will guide you through all aspects of your clinical trials, including:

• Document development and change control
• Records management, accountability and retention
• Conflict of interest
• Assessing study feasibility
• Investigational product management
• Protocol compliance
• Informed consent
• Protecting confidential information
• Clinical data management
• Electronic data management systems
• Inspections by regulatory authorities

Each of the 26 SOPs within this volume will provide you with valuable information on:

• Policy
• Scope
• Responsibility
• Process overview
• Specific procedures
• Applicable regulations, standards and guidelines
• References to related SOPs

Plus, SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sites integrates information from the latest FDA guidance, so you’ll understand:

• Procedural changes to align with the revised Common Rule
• General responsibilities of investigators
• Changes in current wording/emphasis needed to align with current best practices
• Use of electronic health records for source documents
• Changes in procedures needed to align with ICH E6(R2)
• Payment and reimbursement to research subjects — information sheet
• Institutional review board (IRB) written procedures
• Waiver of IRB requirements for drug and biological product studies
• Collection of race and ethnicity data in clinical trials
• IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects
• Minutes of IRB meetings — guidance for institutions and IRBs
• Use of electronic informed consent in clinical investigations — questions and answers

This comprehensive volume is organized into six sections that cover every aspect of clinical research:

• General administration, which includes SOPs on assuming and fulfilling responsibility for GCP, document development and change control, and records management and accountability and retention
• Regulatory affairs, including initial and ongoing submissions and conflict of interest
• Project management, which includes SOPs on assessing study feasibility, investigational product management, monitoring visits and compliance with protocol
• Subject management provides SOPs for subject recruitment, eligibility and enrollment and protecting confidential information
• Data management, which focuses on clinical data management and electronic data management systems
• Quality assurance, which provides procedures for audits and inspections by regulatory authorities

SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sites will provide you with peace of mind, allowing you to make sure all aspects of your clinical research operations are compliant. Every site needs that! You’ll get a downloadable MS Word Template with 26 individual customizable SOPs that make compliance stress-free. You’ll also get 26 valuable supporting documents and templates, including:

• Regulatory file content checklist
• IRB submission checklist
• Conflict of interest reporting forms
• Study budget worksheet
• Source documentation checklist
• Specimen shipping log

About the Author

Anthony Robinson has worked within clinical operations, regulatory, product strategy and business development at companies including Covance, Shire and Barclay Consulting LLC for the past 27 years. Currently president of Barclay Consulting, Mr. Robinson has led clinical trial and portfolio programs, submitted multiple pharmaceutical regulatory applications among various therapeutic areas, managed various collaborative service and site providers, executed market/business analyses and worked with teams to establish and optimize industry and regulatory-compliant operating processes.

Who Will Benefit

• Quality assurance
• Regulatory affairs
• Principal investigators
• Clinical trial associates
• Clinical trial coordinators
• Laboratory personnel