The CRA’s Guide to Monitoring Clinical Research, Fifth Edition

Accelerate your CRA career and get instant answers to your toughest clinical research procedural questions

Use this guide to turbo charge your career.

The faster you attain advanced levels of competence — especially on new electronic portals, questionnaires and processes — the more self-assured you’ll be and the more rapid your career development.

Likewise, in order to instill confidence in your clinical research teams, it pays when you show unhesitating knowledge of current FDA regulations, as well as Good Clinical Practice and pharmaceutical research guidelines from prevailing authorities.

This new edition of The CRA’s Guide to Monitoring Clinical Research — all 750 pages — helps you do both: You’ll have the profession’s definitive description of CRA job responsibilities, including new digital processes, as well as a complete guide to procedural regulations and guidelines.

Even as the CRA’s role becomes more complex, this new edition of The CRA’s Guide to Monitoring Clinical Research keeps you steps ahead.

The Guide puts you on the forefront — so you can help lead the way using new digital developments in clinical research to improve safety reporting, informed consent, and patient-reported outcomes.

The CRA’s Guide to Monitoring Clinical Research also ensures that you can rapidly embrace emerging techniques, such as remote monitoring, wearable devices and tablets … and smoothly adapt, integrate and employ them to the fullest advantage of your research.

Only The CRA’s Guide also helps you command the “soft skills” critical to a successful CRA career including:

• Communication insights: Every veteran CRA confirms it: Your success absolutely depends on communicating effectively with all members of your clinical research teams. That’s why The CRA’s Guide to Monitoring Clinical Research offers dozens of communications take-aways — inside techniques to attaining smooth cooperative relationships with your sites, as well as maintaining a high standard of due diligence.
• High index of suspicion: The CRA’s Guide is the only resource that helps you develop a sharp eye for potential problems and errors that can threaten the integrity of clinical trials. This heightened awareness helps the CRA know when to “communicate and escalate” in a timely fashion to prevent protocol or GCP violations.

The most complete guide to successful practices of high-performing CRAs — helps you respond to thousands of challenges in your busy career.

You’ll never need another professional guide — this one covers it all in 750 pages:

• 1. What is a CRA? Personality, Preparation, Future, Your Value
• 2. History Behind the Regulations: Human Subject Milestones
• 3. Regulations and GCPs: FDA, IHC, NIH, BIMO, Good Clinical Practice
• 4. Roles and Responsibilities in Clinical Trials: Sponsors, Review Boards, CIs
• 5. Research Process: Preclinical, IND Application, Clinical Trials
• 6. Devices and Biologics: Biologics and Vaccines
• 7. Globalization of Clinical Trials: Managing Multinational Trials
• 8. Institutional Review Boards and Data Safety Monitoring Boards
• 9. Informed Consent: Monitoring, Obtaining, Exceptions, Electronic
• 10. Preparing for a Study: Study Design and Statistical Issues
• 11. Preparing for a Study: Protocols, Case Reports, Electronic Data Capture
• 12. Clinical Investigators: Responsibilities, Locating, Evaluating, Selecting
• 13. Study Initiation: Documents, Financial Disclosure, Critical Meetings, Files
• 14. Study Monitoring: Plan, Visits, Confidentiality, Visit Reports, Follow-up
• 15. Adverse Events and Safety Monitoring: Regulations, Common Problems
• 16. Recruitment, Retention and Compliance: Study Subjects, Strategies, Retention
• 17. Study Closeout: Reasons, Procedures
• 18. Quality Management: Site Metrics
• 19. Audits: Sponsor Audits, IRB Audits, FDA Audits
• 20. Errors, Misconduct and Fraud
• 21. The Future for CRAs: Technology, Increased Responsibility, Regional Monitoring
• Appendix A: Resources
• Appendix B: Hints and Tips
• Appendix C: Sample Forms, Checklists and Logs
• Appendix D: Job Descriptions and Academic Programs
• Appendix E: ICH-FDA Comparison
• Appendix F: Harmonized Tripartite Guideline for Good Clinical Practice
• Appendix G: Title 21—Food and Drugs
  • Part 11—Electronic Records
  • Part 50—Protection of Human Subjects
  • Part 54—Financial Disclosure by Clinical Investigators
  • Part 56—Institutional Review Boards
  • Part 314—Applications for FDA Approval to Market a New Drug
  • Part 600—Biological Products
  • Part 601—Licensing
  • Part 610—General Biological Products Standards
  • Part 812—Investigational Device Exemptions
  • Part 814—Pre-market Approval of Medical Devices
• Appendix H: Exercises with Answers

The smartest investment you can make in your CRA library: Just $120

Who Will Benefit

• CRAs or clinical research monitors
• Clinical research managers or other clinical research staff with an interest in study monitoring
• Health professionals interested in pursuing a career as a study monitor
• Instructors conducting internal or external training and education programs
• Sites
• CROs