SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Medical Device Trials

Regulatory compliance is a moving target with requirements for clinical research operations changing and developing all the time.

Are your clinical procedures keeping pace with evolving GCPs?

Would it make your life easier to have a set of proven-compliant procedures for all aspects of your clinical research operations?

With over 1,000 pages chocked full of information, SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Medical Device Trials has the answers you need.

SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Medical Device Trials is organized in eight sections:

• General Administration outlines the activities that form the infrastructure of a clinical research program.
• Regulatory Affairs includes information about working with the FDA and outlines requirements for submissions, supplements and reports that must be sent to the FDA.
• Clinical Protocol includes requirements for protocol development review and approval and related documents.
• Study Startup includes the required steps to select and qualify investigative sites and to initiate a study at a research site.
• Project Management describes processes for managing the clinical investigation, including investigational product management and study documentation requirements.
• Subject Management provides procedures related to protection of research subjects.
• Data Management focuses on the management and handling of data collected during the clinical investigation at study sites and the use of Electronic Data Capture (EDC) systems.
• Quality Assurance provides procedures for conducting internal audits, auditing investigative sites, managing an FDA inspection and assisting a Clinical Investigator in preparing for an FDA inspection.

The manual is a collection of 27 SOPs for clinical research on investigational devices and provides you with the latest word on how to handle all aspects of your trials, including:

• Sponsor responsibilities and delegation
• Investigational device management
• Controlled documents and change control
• Research team training
• Conflict of interest disclosure
• Regulatory submissions and reporting requirements
• Investigational plan development
• Investigator selection and qualification
• Site enrollment and initiation
• Study closeout
• Human subject recruitment and protection
• Adverse device effects
• Data management and electronic systems
• Quality assurance audits and inspections

Whether you put the manual to practical daily use or to develop your training program, you’ll have the following information to guide you in each SOP:

• Policy
• Scope
• Responsibility
• Process overview
• Specific procedures
• Applicable regulations, standards and guidelines
• References to related SOPs
• List of relevant attachments provided in the appendix (64 in all), including forms, checklists, guidelines, templates and more.

The SOPs are structured to easily allow customization to match your company’s unique organization and internal processes. This approach allows users to choose their preferred methods for achieving goals. And it also allows companies of various sizes and levels of complexity to efficiently adopt these SOPs.

With SOPs for GCP-Compliant Clinical Trials: A Customizable Manual for Sponsors of Medical Device Trials, you’ll get an MS Word document of 27 SOPs and 64 related attachments that can be customized to meet your needs.

About the Authors

Sharon A. (Sherri) Bracy, M.A., has more than 27 years of experience in drug and device clinical development. She is principal of Bracy Consulting, at which she has developed processes and SOPs for clients (academic, nonprofit and industry) and supported implementation of new processes and procedures, including training programs. She has held positions of increasing responsibility and scope at Alcon Laboratories, R&D division, from biostatistician to clinical monitor, to positions focused on standards, processes, procedures and training. She established standard global clinical processes and procedures for both drug and medical devices studies, implemented clinical trial management and data systems and developed a comprehensive study manager and study monitor training program for both technical and soft skills (GCP, SOPs, clinical project management, monitoring). As director of R&D training, she developed and implemented training programs in quality systems, business competencies and business systems. She also led a quality process improvement group in defining and improving R&D business processes. She is a member of DIA and ACRP.

Jerry M. Stein, Ph.D., ACRP-CP, is a scientist with more than 40 years of experience conducting research in the clinic and the laboratory. He currently is a clinical research consultant working with emerging pharmaceutical and medical device companies. He is also an independent medical writer engaged in developing drug and medical device regulatory documents, project plans, manuscripts and clinical SOPs. During his long career at Alcon Laboratories, he progressed from clinical monitor to leading the centralized U.S. clinical monitoring organization. He brings a practical approach to the development of clinical SOPs based on his experience working on several SOP development teams, preparing FDA and international submissions, managing a complex monitoring organization and troubleshooting problematic study sites. He led successful R&D and clinical projects leading to the marketing of many of today’s most popular lens care and OTC dry eye products. He received a doctoral degree from Syracuse University in behavioral neuroscience. He has published more than 30 articles and is a member of the Association of Clinical Research Professionals (ACRP), American Medical Writers Association and the American Academy of Optometry. He serves as the Chair of ACRP’s editorial advisory board for their peer-reviewed journal, Clinical Researcher, and is an active member of several of the organization’s key committee.

Who Will Benefit

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