A clinical trial is complex, with numerous regulations, administrative processes, medical procedures, deadlines, and specific protocol instructions to follow. The Sourcebook for Clinical Trials provides a comprehensive overview of the clinical trial process covering the basics to more advances topics. The book discusses foundational elements defining clinical trials and types of research studies, research personnel and responsibilities, and understanding the role of HIPAA and PHI. The book also covers pre-trial preparation and regulatory requirements, subject recruitment, mechanics and trial conduct, review boards and agencies involved in the clinical trial process as well as post-trial study closeout. The inclusion of helpful resources, sample forms, and checklists make The Sourcebook for Clinical Trials an essential step-by-step resource for those involved in conducting, managing, or overseeing clinical trials.
- Offers guidance that is crucial for guaranteeing compliance to clinical trial protocols during each stage of the clinical trial process
- Lays out vital information in an easy, accessible format to keep investigative teams current on federal regulations and good clinical practice
- Provides up-to-date and extensive coverage of Federal and IRB regulations and helpful worksheets, templates, checklists, and protocol resources for clinical trial personnel to utilize
SECTION ONE: FOUNDATIONAL ELEMENTS a. What is the purpose of medical research? b. Defining the Types of Research Studies a. What is a Clinical Trial? b. How does a Clinical Trial differ from Clinical Research? c. How to Secure a Clinical Trial d. Marketing Your Medical Facility to Sponsors e. Principal Investigator Responsibilities f. Research Coordinator Responsibilities g. Understanding the Role of HIPAA and PHI in a Clinical Trial
SECTION TWO: PREPARATION AND REGULATORY REQUIREMENTS BEFORE THE CLINICAL TRIAL BEGINS a. A Clinical Trial Contract (also known as a Clinical Services Agreement or a Clinical Trial Agreement) b. Consent Forms and Documentation a. Consent regulations and a sample consent form b. Advanced Topics and sample language: i. Certificate of Confidentiality ii. Genetic Information Nondiscrimination Act (GINA) iii. Tissue Specimen Banking iv. Determining Cognitive Ability to Consent c. Assent for Children d. Waiver of consent e. The Clinical Trial's Medicare Coverage Analysis f. The Clinical Trial Budget g. The Confidentiality Disclosure Agreement (also known as the Non-Disclosure Agreement) h. Clinical Trial Feasibility Analysis i. Conflict of Interest Considerations in a Clinical Trial j. How to Register a Clinical Trial at [external URL]
SECTION THREE: RECRUITING CLINICAL TRIALS SUBJECTS a. Activities Preparatory to Research for Clinical Trials b. How to Recruit Subjects for a Clinical Trial c. How to Advertise a Clinical Trial
SECTION FOUR: MECHANICS OF A CLINICAL TRIAL a. The Various Forms Used in a Clinical Trial b. Regulatory Binder Checklist c. Study Closeout Checklist d. Project Management for Clinical Trials e. Choosing a Clinical Trials Management System (CTMS) f. De-identification and Chart Reviews g. Clinical Trial Coding for Claims and Billing Considerations
SECTION FIVE: BOARDS AND AGENCIES INVOLVED IN CLINICAL TRIALS a. The Institutional Review Board and the Clinical Trial b. Data Safety Monitoring Board c. FDA Audits d. Clinical Trials and the Association for the Accreditation of Human Research Protection Programs (AAHRPP)
SECTION SIX: CLINICAL TRIAL CONDUCT
A DAILY PERSPECTIVE a. Adverse Events and Reporting in a Clinical Trial b. AE and Reporting Table c. The Code of Federal Regulations and ICH GCP (International College of Harmonization Good Clinical Practice) d. FDA vs HHS regulations e. Blinding and Unblinding in a Clinical Trial f. Translation and Interpretation
SECTION SEVEN: AFTER THE TRIAL IS OVER a. Study Closeout b. Document Retention in a Clinical Trial and Retention Timetable c. Publishing the Results of a Clinical Trial d. ICH GCP Essential Documents
SECTION EIGHT: EXCEPTIONAL CIRCUMSTANCES IN CLINICAL TRIALS a. Expanded Access Protocol (Compassionate Use) in a Clinical Trial b. Charging for an Investigational New Drug in a Clinical Trial c. Emergency Use of a Test Article in a Clinical Trial d. Research on Decedents and PHI in a Clinical Trial e. Children in Clinical Trials f. Impaired Decision Making Capacity (IDMC) g. Research Subject Advocate, Legally Authorized Representative and Witness
SECTION NINE: EDUCATION AND CERTIFICATION IN CLINICAL TRIALS a.Certifications in Clinical Trials
SOCRA, ACRP, MAGI b. Selected College Programs in Clinical Trial Conduct
SECTION TEN: NEWEST CHANGES a. SIRB (Smart IRB) b. Clinicaltrials.gov registration and reporting c. ICH GCP E6 R2 d. Common Rule change
Accomplished six sigma black belt operations expert and health care professional with more than 15 years of senior-level experience in healthcare management and clinical research at prominent U.S. institutions. Demonstrated success in operations, regulatory compliance, financial management, contracting, personnel management, marketing and training. Experience in all medical disciplines, including: cardiology, oncology, psychiatry, infectious disease, endocrinology and ophthalmology. Extensive knowledge of CFR, ICH GCP, and HIPAA regulations. Expertise in investigator initiated and industry sponsored trials, including negotiations with Pfizer, Glaxo Smith Kline, Shire, Merck, and Medtronics, with CROs such as ICON, inVentiv, and Parexel; and with NIH subawards through Duke Clinical Research Institute, St. Jude's Children's Research Hospital, and Children's Hospital of Philadelphia. Over 900 clinical trials managed. Professional affiliations include SOCRA, NCURA and MAGI; Maryland SOCRA Chairperson, 2008 - 2011.
Accomplished communications professional with more than 25 years of senior-level experience in media relations, speechwriting, campaign advance, and journalism. Demonstrated success in the Legislative Branch and the Executive Branch; served as a Presidential appointee in the U.S. Departments of State and Health and Human Services and as a senior career official in the audit and oversight community. Extensive work in health care, entitlements, and defense matters. 14 years of service in the U.S. Army Reserve/Army Guard with an Honorable Discharge and receipt of federal Cabinet awards.