Intended AudienceCollege Audience
Reviews'I have yet to find a more comprehensive and readable book on clinical trials. The authors have done a wonderful job and have provided a commendable service to the medical community.'- The Journal of the American Medical Association , 'I have yet to find a more comprehensive and readable book on clinical trials. The authors have done a wonderful job and have provided a commendable service to the medical community.' - The Journal of the American Medical Association
IllustratedYes
Table Of Content1. Lessons from a horse named Jim: A History of Regulations Affecting Clinical Research 2. The Process: Developing New Drugs and Devices 3. Good Clinical Practice and the Regulations 4. Informed Consent and Regulations 5. Adverse Effects 6. Monitoring 7. Deciding to be a Principal Investigator 8. The Protocol 9. Study Activities 10. Study Documents 11. Study Drug Management 12. Patient Data Forms 13. Appendices
SynopsisAn exciting, well-produced, practical volume giving pragmatic conduct and process of clinical trials bridging the gap between the theory of clinical trial design and statistical and clinical interpretations of data., Written by members of the Duke Clinical Research Institute (DCRI) who develop instructional materials for on-site clinical trialists, this exciting, well-produced, practical book bridges the gap between the theory of clinical trial design, along with the statistical and clinical interpretations of data, and the process of conducting clinical trials. The authors have pulled together information relating to the pragmatic conduct of clinical trials and organized all of it into a single, invaluable volume.