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The sourcebook for clinical research : a practical guide for study conduct / Natasha Martien, Jeff Nelligan.
Connect to full text Available online
View online- Format:
- Book
- Author/Creator:
- Martien, Natasha, author.
- Nelligan, Jeff, author.
- Language:
- English
- Subjects (All):
- Clinical trials.
- Clinical Trials as Topic.
- Medical Subjects:
- Clinical Trials as Topic.
- Physical Description:
- 1 online resource
- polychrome
- Place of Publication:
- London, United Kingdom : Academic Press is an imprint of Elsevier, [2018]
- System Details:
- text file
- Contents:
- 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
- Notes:
- Includes bibliographical references and index.
- Electronic reproduction. Ann Arbor, MI Available via World Wide Web.
- Description based on online resource; title from digital title page (viewed on September 04, 2018).
- ISBN:
- 9780128162439
- 0128162430
- Publisher Number:
- 99977907598
- Access Restriction:
- Restricted for use by site license.
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