A report on the sponsors of cancer treatment clinical trials and their approval and monitoring mechanisms /
| Hoofdauteur: | |
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| Coauteur: | |
| Formaat: | Licensed eBooks |
| Taal: | Engels |
| Gepubliceerd in: |
Washington D.C. :
National Research Council,
1999.
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| Online toegang: | https://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&AN=123575 |
Inhoudsopgave:
- A Report on the Sponsors of Cancer Treatment Clinical Trials and Their Approval and Monitoring Machanisms
- Copyright
- Preface
- Report Reviewers
- Contents
- SUMMARY
- Cancer Treatment Trial Sponsors
- Quality Standards for Cancer Treatment Trials
- Common Elements of Clinical Trial Review Criteria
- Reviews for Scientific Merit
- Reviews and Procedures to Ensure the Safety and Rights of Participants
- INTRODUCTION
- ELIGIBILITY OF MEDICARE PATIENTS FOR CANCER CLINICAL TRIALS
- CRITERIA AND PROCEDURES FOR APPROVING AND MONITORING CLINICAL TRIALS
- The Two Prongs of Clinical Trial Protocol Review and MonitoringThe National Cancer Institute
- The Cancer Therapy Evaluation Program
- The Cancer Centers Program
- Department of Veterans Affairs
- The Cooperative Studies Program
- VA-Funded Research at Single VA Medical Centers
- INSTITUTIONAL REVIEW BOARDS
- THE FOOD AND DRUG ADMINISTRATION
- The Commercial IND Application
- Noncommercial INDs
- Protection of Human Subjects
- COMMON ELEMENTS OF CLINICAL TRIAL REVIEW CRITERIA
- Reviews for Scientific Merit