The sourcebook for clinical research : a practical guide for study conduct /: a practical guide for study conduct. (2018)

• Record Type: Book
• Further Information: Note: Natasha Martien, Jeff Nelligan.
• Authors: Martien, Natasha; Nelligan, Jeff
• Contents: 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 www.ClinicalTrials.gov 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
• Publisher Details: London : Academic Press
• Publication Date: 2018
• Extent: 1 online resource
• Subjects: 615.5072/4; Clinical trials; MEDICAL / Pharmacology; Electronic books
• Languages: English
• ISBNs: 9780128162439; 0128162430
• Related ISBNs: 9780128162422; 0128162422
• Notes: Note: Includes bibliographical references and index.; Note: Online resource; title from PDF title page (EBSCO, viewed August 9, 2018)
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.