Medical Device Clinical Trials Guide from C.H.I.P.S.

Design, Execution, and Management of Medical Device Clinical Trials
by Salah M. Abdel-Aleem

Design, Execution, and Management of Medical Device Clinical Trials provides a uniform methodology for conducting and managing clinical trials.

Throughout the book, practical examples are discussed in a sequential manner as they occur in the study, starting from the development of the clinical protocol and the selection of clinical sites and ending with the completion of the final clinical study report.

Next, readers are guided through the development of important clinical documents, including informed consent forms, case report forms, and study logs. A careful review of the Food and Drug Administration (FDA) and International Conference on Harmonisation (ICH) regulations applicable to medical devices is also featured.

Additional coverage includes:

  • Qualification and selection of investigators
  • Study monitoring visits
  • Definitions and reporting procedures for adverse events
  • The use of biostatistical methodology in clinical research, including the use of biostatistics for sample size determination and study endpoints
  • The roles and responsibilities of all members of a clinical research team

The book concludes with an insightful discussion of special ethical conduct for human research and challenging issues to consider during the design of clinical studies. A glossary lists important clinical and statistical terms used in clinical research, and an extensive reference section provides additional resources for the most up-to-date literature on the topic.


  1. An overview of clinical study tasks and activities
  2. Development of clinical protocols, case report forms, clinical standard operating procedures, informed consent form, study regulatory binder, study research agreement, and other clinical materials
  3. Qualifications/selection of study investigators and study monitoring visits
  4. Adverse events definitions and reporting procedures
  5. Statistical analysis plan (SAP) and biostatistics in clinical research
  6. Final clinical study report
  7. Medical device regulations, combination product, study committees, and FDA-sponsor meetings
  8. Design issues in medical devices studies
  9. Investigator-initiated clinical research
  10. Ethical conduct for human research

Glossary of clinical trial and statistical terms

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Design, Execution, and Management of Medical Device Clinical Trials
by Salah M. Abdel-Aleem
2009 272 pages $83.95 + shipping
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