SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Drug and Biologics Trials

If you’re challenged by changing clinical trial rules and procedures, SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Drug and Biologics Trials is exactly what you need. This is the industry’s most comprehensive, customizable and easy-to-use set of SOPs.

This is an entire compliance library in one complete volume, including the latest on:

• New requirements established in the 2016 revision of ICH E6
• New FDA guidances, including new data integrity expectations
• The impact of risk-based monitoring
• Processes addressing the use of new technology in conducting clinical trials
• The impact of the revised Common Rule
• The increased use of centralized institutional review boards (IRBs)

With SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Drug and Biologics Trials, you’ll get 33 individual SOPs to use as is or to customize to meet your organization’s specific needs and in all aspects of your trials — from general administration and regulatory compliance, to trial design, operation and analysis.

You’ll find extremely valuable sections on:

• General administration, with SOPs on fulfilling regulatory obligations, document development and change control, and sponsor research team training
• Regulatory affairs, with SOPs on FDA contacts and meetings, and FDA submissions
• Protocol development, which addresses elements of trial design including case report forms, protocol amendments and investigator documents
• Study start-up, which focuses on investigator selection and qualification and initiation visit and site training
• Clinical operations and project management, with SOPs on communications with IRBs, managing investigational product management, records retention, close-out visits and termination of research
• Subject management, with SOPs on human subject protection, recruitment, protected information and adverse event recognition
• Data management, which focuses on data collection and transcription and electronic data collection and management
• Quality assurance, with SOPs on audits and regulatory inspections
• Interim analysis, which includes SOPs on assessing the need for and establishing a data monitoring committee

In addition to the downloadable MS Word Template of 33 SOPs, SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Drug and Biologics Trials has 82 related resources including forms, checklists and templates to help you carry out your SOPs with ease. These key resources include:

• Delegation of Responsibility Form
• SOP Template
• IND Format and Content Checklist
• Feasibility Evaluation Report
• CAPA Plan Form
• Electronic Data Management 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

• Pharmaceutical company professionals involved with clinical trials
• Biotech company professionals involved with clinical trials
• Clinical operations professionals
• Clinical affairs professionals
• Quality assurance professionals
• Regulatory professionals
• Compliance professionals using FDA, ICH and GCP guidelines